ZONARE ZS3 DIAGNOSTIC UNLTRASOUND SYSTEM
Device Facts
| Record ID | K120703 |
|---|---|
| Device Name | ZONARE ZS3 DIAGNOSTIC UNLTRASOUND SYSTEM |
| Applicant | Zonare Medical Systems, Inc. |
| Product Code | IYN · Radiology |
| Decision Date | Apr 13, 2012 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric, 3rd-Party Reviewed |
Indications for Use
The device is intended for use by a qualified physician for ultrasound evaluation of: Ophthalmic; Fetal/obstetric, gynecological; Abdominal (renal, GYN/Pelvic; Intra-operative (abdominal, thoracic, and vascular), Intra-operative neurological; Pediatric; Small organ (thyroid, breast, testes, etc), Adult & Neonatal Cephalic; Trans-rectal, Trans-vaginal, Trans-cranial, Trans-esophageal (non-cardiac); Musculoskeletal (conventional & superficial); 3D/4D; Cardiac - Adult/Pediatric/Fetal; Echo, Intra-Cardiac; Pelvic: Peripheral vascular; harmonic tissue and contrast imaging and Tissue elasticity, Vet and others as stated in 1.3.
Device Story
ZONARE ZS3 is a mobile, general-purpose diagnostic ultrasound system. It integrates a previously cleared portable scanner into a dedicated cart, creating a streamlined, non-convertible unit. The system uses the same software base as the ZONARE z.one Ultra. It receives ultrasound signals via transducers, which are digitized and preprocessed by the system. The system supports B-mode, M-mode, Pulsed Wave Doppler, Color Doppler, and harmonic/contrast imaging. It includes multi-transducer ports, an embedded hard drive, and a DVD drive. Operated by physicians in clinical settings, the system provides real-time ultrasound images to assist in diagnostic evaluations. The integration of components into the cart base is intended to improve image quality through a higher signal-to-noise ratio and support future enhancements. The device is used for a wide range of clinical applications, including cardiac, vascular, and musculoskeletal imaging, aiding in clinical decision-making through visual diagnostic data.
Clinical Evidence
No clinical data. The device relies on bench testing, including verification and validation of software, acoustic output, biocompatibility, and electrical/mechanical safety standards (IEC 60601 series, ISO 10993, ISO 14971).
Technological Characteristics
Mobile ultrasound system using patented zone sonography. Features multi-transducer ports, embedded hard drive, and DVD. Connectivity includes standard ultrasound interfaces. Software-driven signal processing. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, and ISO 10993. Sterilization/disinfection follows standard clinical protocols for transducers.
Indications for Use
Indicated for qualified physician use for diagnostic ultrasound imaging or fluid flow analysis of the human body, including ophthalmic, fetal/obstetric, gynecological, abdominal, intra-operative, pediatric, small organ, cephalic, trans-rectal, trans-vaginal, trans-cranial, trans-esophageal, musculoskeletal, cardiac, and peripheral vascular applications.
Regulatory Classification
Identification
An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Predicate Devices
Reference Devices
Submission Summary (Full Text)
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# ZONARE 510(k) Summary of Safety & Effectiveness
Prepared in accordance with 21 CFR Part 807.92(c)
APR 1 3 2012
| The assigned 510(k) number is: | K120703 |
|--------------------------------|---------|
|--------------------------------|---------|
Applicant Information:
| Date Prepared: | February 22, 2012 |
|---------------------|--------------------------------------------------------------------------------------|
| Name: | ZONARE Medical Systems, Inc.<br>420 North Bernardo Avenue<br>Mountain View, CA 94043 |
| Contact Persons: | Linda J. Moore<br>Director, Regulatory Affairs & Quality Assurance |
| Telephone Numbers: | 650-230-2724 |
| Fax Number: | 650-967-9036 |
| Email | lmoore@zonare.com |
| Device Information: | |
| Trade Name: | ZONARE ZS3 Ultrasound System |
Device Name: ZONARE Diagnostic Ultrasound System
| | FR Number | Product Code |
|------------------------------------------|-----------|--------------|
| Ultrasonic Pulsed Doppler Imaging System | 892.1550 | 90-IYN |
| Ultrasonic Pulsed Echo Imaging System | 892.1560 | 90-IYO |
| Diagnostic Ultrasound Transducer | 892.1570 | 90-ITX |
Marketed Device(s): The ZONARE ZS3 Ultrasound System is a combination of the currently marketed ZONARE z.one Ultra Ultrasound System consisting of a convertible scanner and cart(s) previously cleared on (K082326) (K101091). The ZS3 combines the scanner and cart into a singular unit, which still resembles the currently marketed z.one Ultra Ultrasound system in looks, features and functionalities, including the same software revision, driving both systems.
Device Description: The ZONARE ZS3 is a general purpose diagnostic ultrasound system which consists of a the previous cleared portable scanner integrated into the ZONARE z.one Ultra Smartcart to enable the user to focus on performing patient scans with a more streamline unit. No longer convertible, the ZONARE ZS3 will still be considered a mobile system as it will be lightweight and easy to move from room to room. The new system, which uses the same software base as the currently approved z.one Ultra ultrasound system, will have . hardware changes which are minimal, but require some redesign in the cart base in order to put working components of the scanner inside the cart. Otherwise, the user interface and other features/functionalities of the system are substantially equivalent to the ZONARE Ultra Ultrasound System in both indications for use and system functionality. The new ZS3 will be based on the ZONARE's patented zone sonography, and with the scanner's internal components now inside the cart base, the ZS3, without compromising safety and
510k Submittal ZONARE Medical Systems. Inc.
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effectiveness, should improve image quality through a higher signal to noise ratio, as well as support a wider range of future enhancements. Features, such as multi transducer ports will be standard in the system as will an embedded hard drive and DVD. The system with the ZONARE Ultra current suite of transducers. Signals received from the transducer module are digitized and preprocessed. The transducer module comes into contact with the patient and both transmit and receive ultrasound energy. There is no difference between the currently cleared ZONARE transducers (K101091) and the transducers as shown in this submission for the ZS3.
The system provides holders for transducer models, and will be offered with battery chargers and other accessories. The modification for this submission includes no new indication for use but does have 1 transducer the C10-3 added as appendix E to the ZONARE z.one Ultra Ultrasound system which will be declared new to this system.
Indications For Use: The device is intended for use by a qualified physician for ultrasound evaluation of: Ophthalmic; Fetal/obstetric, gynecological; Abdominal (renal, GYN/Pelvic; Intra-operative (abdominal, thoracic, and vascular), Intra-operative neurological; Pediatric; Small organ (thyroid, breast, testes, etc), Adult & Neonatal Cephalic; Trans-rectal, Trans-vaginal, Trans-cranial, Trans-esophageal (non-cardiac); Musculoskeletal (conventional & superficial); 3D/4D; Cardiac - Adult/Pediatric/Fetal; Echo, Intra-Cardiac; Pelvic: Peripheral vascular; harmonic tissue and contrast imaging and Tissue elasticity, Vet and others as stated in 1.3.
Comparison with Predicate Device: With respect to features and applications, the ZONARE ZS3 Ultrasound System, is comparable and substantially equivalent to the currently marketed ZONARE z.one Ultrasound System, and the additional predicate device listed in predicate devices section in terms of features and functionality. Additionally, the ZONARE ZS3 Ultrasound System and the ZONARE z.one Ultrasound System have the same important safety and effectiveness features, as well as share the same software, materials, and design/construction as shown in the predicate device comparison table.
Non-clinical tests: The device has been evaluated according to the applicable medical device quality systems, safety standards for acoustic output, biocompatibility, verification and validation, cleaning, and disinfection effectiveness as well as for thermal, electrical, and mechanical safety, those applicable to ZONARE's ultrasound product(s) are:
| ISO 14971 | Medical Devices – applications of risk management to medical devices |
|----------------|-------------------------------------------------------------------------|
| IEC/UL 60601-1 | Medical Electrical Equipment (MEE) – General Requirements for Safety |
| IEC 60601-1-1 | Medical Electrical Equipment for Systems |
| IEC 60601-1-2 | EMC |
| IEC 60601-1-4 | MEE – Programmable electrical medical systems |
| IEC 60601-2-37 | Safety of ultrasonic medical diagnostic and monitoring equipment |
| IEC 62304 | Medical Device software – software life cycle processes |
| ISO 10993 | Biological evaluation of medical devices |
| AIUM | Medical Ultrasound Safety, American Institute of Ultrasound in Medicine |
Clinical Tests: Non Required
Conclusion: The device conforms to applicable medical device safety standards and compliance for safety and effectiveness which is verified through defined verification and validation, and market surveillance. Driven by the same software, which is used by the currently marketed ZONARE z.one Ultra Ultrasound System, which has been shown to be safety and effective, the ZONARE ZS3 Ultrasound system is substantially equivalent with respect to safety and effectiveness to devices current cleared for market.
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#### DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
APR 1 3 2012
ZONARE Medical Systems, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services 1394 25th Street NW BUFFALO MN 55313
Re: K120703
Trade/Device Name: The ZONARE ZS3 Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, ITX, and IYO Dated: March 28, 2012 Received: March 29, 2012
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices; good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for use with the The ZONARE ZS3 Ultrasound System, as described in your premarket notification:
#### Transducer Model Number
Curvilinear Transducer C4-1 Curvilinear Transducer C6-2 Curvilinear Transducer C9-3 Phased (Sector) Array Transducer C10-3 Curvilinear Transducer C8-3 (3D/4D) Curvilinear Transducer C9-4t Phase (Sector) Array Transducer P4-1c Phased (Sector) Array Transducer P10-4 Endo-Cavity Transducer E9-4 Endo-Cavity Transducer E9-3 (3D)
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Linear Transducer L10-5 Linear Transducer L8-3 Linear Transducer L12-4v Linear Transducer L14-5sp Linear Transducer L14-5w
#### Tran-Esophageal Transducer P8-3TEE
### St. Jude EP ViewFlex PLUS ICE Catheter model # VF-PM Part #09-2005 (off the shelf)(P9-3ic)
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance
If you have any questions regarding the content of this letter, please contact Jeffrey Ballyns at (301) 796-6105.
Sincerely Yours Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure(s)
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# Indications for Use Statement
#### 510(K) Number (if known):
The ZONARE ZS3 Ultrasound system Device Name:
Indications for use:
The device is intended for use by a qualified physician for ultrasound evaluation of Ophthalmic; Fetal/obstetric, gynecological; Abdominal (renal, GYN/Pelvic; Intra-operative (abdominal, thoracic, and vascular), Intraoperative neurological; Pediatric; Small organ (thyroid, breast, testes, etc), Adult & Neonatal Cephalic; Transrectal, Trans-vaginal, Trans-cranial, Trans-esophageal (non-cardiac); Musculoskeletal (conventional & superficial); 3D/4D; Cardiac – Adult/Pediatric/Fetal; Echo, Intra-Cardiac; Pelvic; Peripheral vascular; harmonic tissue and contrast imaging and Tissue elasticity.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C
(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Samue Evans
Division Sign-Off
Division Sign-Off Office of In Vitro Diagnostic Devices Evaluation, and Safet 510(K)
Page 1 of
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#### 1.3. Diagnostic Ultrasound Indications for use
#### 510(K) Number (if known):
### System Name: ZONARE ZS3 Ultrasound Diagnostic System Device Name: System Union of all Transducer Types
Indications for Use: This device is intended for use by a qualified physician for the following: Feal, Abdominal, Intracgerative, Pediatric, Ophthalmic, Intra-cardiats (breast/testes, thyroid, etc), Transvaginal. Transretal, Transranial, Trans-arethal, OBGYN, Cardiac, Pelvic, Neonatal/Adult cephalic, Vasue elasticity, Musculoskeletal, cardiac, Superficial Musculoskeletal, and Peripheral Vascular applications and others as shown below.
| | Clinical Application | | Mode of Operation | | | | | | |
|----------------------------------------------------------------------------------------------------|------------------------------------------------|----|-------------------|------|--------------------|-------------------|-----------------------|-----------|--|
| General | Specific | B | M | PWD2 | CWD/<br>CWD<br>Aux | Color<br>Doppler3 | Combined<br>Modes4 | Other5, 8 | |
| Ophthalmic | Ophthalmic | N | | N | | N | N | | |
| | Fetal | N | N | N | | N | N | N5 | |
| | Abdominal | N | N | N | | N | N | N5 | |
| | Intra-operative (Specify)6 | N | N | N | | N | N | N5 | |
| | Intra-operative (Neuro) | N | N | N | | N | N | N5 | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | N | N | N | | N | N | N5 | |
| | Pediatric Aux | | | | | | | | |
| | Small Organ (Thyroid,<br>Breast, Testes. etc.) | N | N | N | | N | N | N5 | |
| | Neonatal Cephalic | N | N | N | | N | N | N5 | |
| General<br>Application | Adult Cephalic | N | N | N | | N | N | N5 | |
| | Trans-rectal | N | N | N | | N | N | N5 | |
| | Trans-vaginal | N | N | N | | N | N | N5 | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | N | N | N | | N | N | N5 | |
| | Musculo-skel.<br>(Conventional) | N | N | N | | N | N | N5, 8 | |
| | Musculo-skel.<br>(Superficial) | N | N | N | | N | N | N5, 8 | |
| | Intra-luminal | | | | | | | | |
| | Other (Specify)<br>(3D/4D) | N | N | N | | N | N | | |
| Cardiac | Cardiac Adult | N1 | N | N | | N | N | N5 | |
| | Cardiac Adult Aux | | | | | | | | |
| | Cardiac Pediatric | N | N | N | | N | N | N5 | |
| | Cardiac Pediatric Aux | | | | | | | | |
| | Trans-esoph. (Cardiac) | N | N | N | | N | N | N5 | |
| | Other (Specify)<br>(3D/4D) | N | N | N | | N | N | | |
| | Other (Intra-Cardiac)* | N | N | N | | N | N | | |
| Peripheral vascular | Peripheral Vessel | N | N | N | | N | N | N5 | |
| | Peripheral Vessel Aux | | | | | | | | |
| | Other (Specify)<br>(3D/4D) | N | N | N | | N | N | | |
| Clinical Application | Mode of Operation | | | | | | | | |
| General<br>(Track I Only) | Specific<br>(Track 1 & III) | B | M | PWD2 | CWD<br>aux | Color<br>Doppler3 | Combined<br>Modes4 | Other5, 8 | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | P | P | P | | P | P | | |
| | Abdominal | P | P | P | | P | P | | |
| | Intra-operative (Specify)7 | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | P | | P | P | | |
| | Pediatric Aux | | | | | | | | |
| | Small Organ (Thyroid,<br>Breast, Testes, etc.) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skel.<br>(Conventional) | P | P | P | | P | | | |
| | Musculo-skel.<br>(Superficial) | | | | | | | | |
| | Intra-luminal | | | | | | | | |
| | Other (Specify)<br>(3D/4D)<br>contrast | P | P | P | | P | P | | |
| | Cardiac Adult | P1 | P | P | | P | P | | |
| | Cardiac Adult Aux | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| Cardiac | Cardiac Pediatric Aux | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Other (specify) 3D/4D | | | | | | | | |
| | Other (intra-cardiac)* | | | | | | | | |
| | Peripheral Vessel | | | | | | | | |
| Peripheral vascular | Peripheral Vessel Aux | | | | | | | | |
| | Other (Specify) 3D/4D | | | | | | | | |
| N = new indication; P-previously cleared by FDA 510(k) K082326 & K101091, E=Added under Appendix E | | | | | | | | | |
| 1 Includes B-Mode and Harmonic (contrast) imaging (HI) | | | | | | | | | |
| 2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF) | | | | | | | | | |
| 3 Includes Color Doppler (CD); Directional Power Doppler (DPD), and Power Doppler (PD) | | | | | | | | | |
| 4 Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent (CD, DPD, PD, or BD) | | | | | | | | | |
| 5 Color M-Mode (CM) | | | | | | | | | |
| 6 Abdominal includes renal, GYN/Pelvic | | | | | | | | | |
| 7 Intra operative include abdominal, thoracic (cardiac) and vascular (PV) | | | | | | | | | |
| 8 Freehand tissue elasticity | | | | | | | | | |
| Prescription Use | | | | | AND/OR | | Over-The-Counter Use | | |
| (21 CFR 801 Subpart D) | | | | | | | (21 CFR 801 Subpart C | | |
| Clinical Application | Specific<br>(Track I & III) | B | M | PWD2 | CWD | Color<br>Doppler3 | Combined<br>Modes4 | Other5, 8 | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | P | P | P | | P | P | P1 | |
| | Abdominal6 | P | P | P | | P | P | P2 | |
| | Intra-operative<br>(Specify) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | P | | P | P | P3 | |
| General<br>applications | Small Organ (Thyroid,<br>Breast. Testes, etc.) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-<br>Card.) | | | | | | | | |
| | Musculo-skel.<br>(Conventional) | | | | | | | | |
| | Musculo-skel.<br>(Superficial) | | | | | | | | |
| | Intra-luminal | | | | | | | | |
| | Other (Specify) (3D/4D) | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral<br>Vascular | Peripheral Vascular | P | P | P | | P | P | P3 | |
| | Other (Specify) | | | | | | | | |
N = new system indication; P = previously cleared by FDA 510(k), E=Added under Appendix E
Includes B-Mode and Harmonic (contrast) imaging (HI)
2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)
3 Includes Color Doppler (CD). Directional Power Doppler (DPD). and Power Doppler (PD)
' Includes B+M. B+M+CM. B+CD+M+CM. B+CD+PWD where CD could represent (CD. DPD. PD. or BD)
5 Color M-Mode (CM)
Abdominal includes renal. GYN/Pelvic
Intra operative include abdominal, thoracic (cardiac) and vascular (PV)
Freehand tissue elasticity
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C
## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off Office of In Vitro Diggnostic Devices Evaluation and 510(K)
Page 1 of
510(k) Submittal ZONARE Medical Systems, Inc.
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# System Name: ZONARE ZS3 Ultrasound Diagnostic System
Device Name: Curvilinear Transducer C4-1
Indications for Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Con
Division Sign-Off
Office of In Vitro Diagnostic Devices Evaluation and Safety 510(K) 416016
Page 1 of _
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### System Name: ZONARE ZS3 Ultrasound Diagnostic System
Device Name: Curvilinear Transducer C6-2
Indications for Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P=previously cleared by FDA 510(k) K082326 & K101091, E=Added under Appendix E
Includes B-Mode and Harmonic (contrast) imaging (HI)
2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)
3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)
4 Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent (CD, DPD, PD, or BD)
3 Color M-Mode (CM)
6 Abdominal includes renal, GYN/Pelvic
7 Intra operative include abdominal, thoracic (cardiac) and vascular (PV)
8. Freehand tissue elasticity
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
ffice of In Vito Diagnostic Devices 510(K)
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#### System Name: ZONARE ZS3 Ultrasound Diagnostic System
Device Name: Curvilinear Transducer C9-3
Indications for Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | 一方面。在此中的一次,一起来了。 在 | | | Mode of Operation ! \ \ 22 > > > > > | | | ーのある。 。 | |
|-------------------------|------------------------------------------------|-----|---|--------------------------------------|-----|------------------|--------------------|-----------|
| General | Specific<br>(Track I & III) | B | M | PWD2 | CWD | Color<br>Doppler | Combined<br>Modes* | Other . * |
| Ophthalmic | Ophthalınic | | | | | | | |
| | Fetal | P | P | P | | P | P | P |
| | Abdominal6 | P · | p | P | | P | P | ps |
| | Intra-operative<br>(Abdominal) | P | P | P | | P | p | P |
| | Intra-operative<br>(Vascular) | P | P | P | | P | P | ર્જિ |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | p | P | | P | P | P> |
| | Small Organ (Thyroid,<br>Breast, Testes, etc.) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| General<br>applications | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-<br>Card.) | | | | | | | |
| | Musculo-skel.<br>(Conventional) | P | P | P | | P | P | ps |
| | Musculo-skel.<br>(Superficial) | P | P | P | | P | P | ్స్ |
| | Intra-luminal | | | | | | | |
| | Other (Specify) (3D/4D) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral | Peripheral Vascular | P | P | P | | P | P | PS |
| Vascular | Other (Specify) | | | | | | | |
N = new indication; P=previously cleared by FDA 510(k) K082326 & K101091, E=Added under Appendix E
1 Includes B-Mode and Harmonic (contrast) imaging (HI)
2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)
3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)
4 Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent (CD, DPD, PD, or BD)
3 Color M-Mode (CM)
6 Abdominal includes renal, GYN/Pelvic
1 Intra operative include abdominal, thoracic (cardiac) and vascular (PV)
8 Freehand tissue elasticity
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
#### Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Raming Ranss
Division Sign Off
of In Vitro Diagnostic Devices 210(K)
4 . .
{9}------------------------------------------------
#### System Name: ZONARE ZS3 Ultrasound Diagnostic System
Device Name: Phased (Sector) Array Transducer C10-3
Indications for Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | |
|------------------------|------------------------------------------------|-------------------|---|------|-----|-------------------|--------------------|--------|
| General | Specific<br>(Track I & III) | B | M | PWD2 | CWD | Color<br>Doppler3 | Combined<br>Modes4 | Other8 |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | N | N | N | | N | N | N5 |
| | Abdominal6 | N | N | N | | N | N | N5 |
| | Intra-operative (specify) | N | N | N | | N | N | N5 |
| | Intra-operative (Neuro) | N | N | N | | N | N | N5 |
| | Laparoscopic | | | | | | | |
| | Pediatric | N | N | N | | N | N | N5 |
| | Small Organ (Thyroid,<br>Breast, Testes, etc.) | | | | | | | |
| | Neonatal Cephalic | N | N | N | | N | N | N5 |
| General<br>application | Adult Cephalic/ trans<br>cranial | N | N | N | | N | N | N5 |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-<br>Card.) | | | | | | | |
| | Musculo-skel.<br>(Conventional) | | | | | | | |
| | Musculo-skel.<br>(Superficial) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | N | N | N | | N | N | N5 |
| | Cardiac Pediatric | N | N | N | | N | N | N5 |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Other (Specify)<br>(3D/4D) | | | | | | | |
| Peripheral vascular | Peripheral Vascular | N | N | N | | N | N | N5 |
| | Other (Specify) 3D/4D | | | | | | | |
P=previously cleared by the FDA . E=Added under Appendix E N = new indication;
1 Includes B-Mode and Harmonic (contrast) imaging (HI)
2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)
3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)
4 Includes B+M, B+M+CM, B+CD+M+CM, B+CD+PWD where CD could represent (CD, DPD, PD, or BD)
2 Color M-Mode (CM)
6 Abdominal includes renal, GYN/Pelvic
7 Intra operative include abdominal, thoracic (cardiac) and vascular (PV)
8 Freehand tissue elasticity
Over-The-Counter Use Prescription Use AND/OR (21 CFR 801 Subpart C (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
#### Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Sammu Mains
Division Sign-Off
Division Sign-Off Office of In Vitro Diagnostic Devices Evaluation and Safety 510(K)
#### 510(K) Number (if known):
510(k) Submittal ZONARE Medical Systems, Inc.
{10}------------------------------------------------
### System Name: ZONARE ZS3 Ultrasound Diagnostic System Device Name: Curvilinear Transducer C8-3 (3D/4D)
Indications for Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Specific<br>(Track I & III) | Mode of Operation | | | | | | |
|-------------------------|------------------------------------------------|-------------------|---|------|-----|-------------------|--------------------|----------|
| General | | B | M | PWD2 | CWD | Color<br>Doppler3 | Combined<br>Modes4 | Other5,8 |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | P | P | P | | P | P | P5 |
| General<br>applications | Abdominal6 | P | P | P | | P | P | P5 |
| | Intra-operative<br>(Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | | P | P | P5 |
| | Small Organ (Thyroid,<br>Breast, Testes, etc.) | | | | | | | |
| | Peonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-<br>Card.) | | | | | | | |
| | Musculo-skel.<br>(Conventional) | | | | | | | |
| | Musculo-skel.<br>(Superficial) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Specify) (3D/4D) | P | P | P | | P | P | P7 |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vascular | Peripheral Vascular | P | P | P | | P | P | P5 |
| | Other (Specify) | | | | | | | |
N = new indication; P=previously cleared by FDA 510(k) K101091, E=Added under Appendix E
I Includes B-Mode and Harmonic (contrast) imaging (HI)
2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)
3 Includes Color Doppler (CD). Directional Power Doppler (DPD), and Power Doppler (PD)
1 Includes B+M, B+M+CM, B+CD+M+CM, B+CD+PWD where CD could represent (CD, DPD, PD, or BD)
3 Color M-Mode (CM)
6 Abdominal includes renal, GYN/Pelvic
7 Intra operative include abdominal, thoracic (cardiac) and vascular (PV)
& Freehand tissue elasticity
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign Off
Division Sign-Off Office of In Vitro Diagnostic Devices Evaluation and 510(K)
510(K) Number (if known):
· 510(k) Submittal ZONARE Medical Systems, Inc.
Page 1 of
б
{11}------------------------------------------------
### System Name: ZONARE ZS3 Ultrasound Diagnostic System Device Name: Curvilinear Transducer C9-4t
Indications for Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application<br>(Track I Only) | | Specific<br>(Track 1 & III) | B | M | PWD2 | CWD | Color<br>Doppler3 | Combined<br>Modes4 | Other5,8 |
|----------------------------------------|------------------------------------------------|-----------------------------|---|---|------|-----|-------------------|--------------------|----------|
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | | | | | | | | |
| | Abdominal | P | P | P | | P | P | | |
| | Intra-operative<br>(Specify)7 | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | P | | P | P | | |
| | Small Organ (Thyroid,<br>Breast, Testes, etc.) | | | | | | | | |
| | Neonatal Cephalic | P | P | P | | P | P | | |
| | Adult Cephalic | | | | | | | | |
| General<br>application | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-<br>Card.) | | | | | | | | |
| | Musculo-skel.<br>(Conventional) | P | P | P | | P | P | | |
| | Musculo-skel.<br>(Superficial) | P | P | P | | P | P | | |
| | Intra-luminal | | | | | | | | |
| | Other (Specify)<br>(3D/4D) | P | P | P | | P | P | | |
| | Vet abdominal | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| Cardiac | Cardiac Pediatric | P | P | P | | P | P | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Other (Specify) vet<br>cardiac | P | P | P | | P | P | | |
| | Peripheral vascular | | | | | | | | |
| Peripheral vascular | Other (Specify) | | | | | | | | |
N = new indication; P=previously cleared by FDA 510(k) 101091, E=Added under Appendix E
1 Includes B-Mode and Harmonic (contrast) imaging (HI)
2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)
3 Includes Color Doppler (CD). Directional Power Doppler (DPD), and Power Doppler (PD)
4 Includes B+M, B+M+CM, B+CD+M+CM, B+CD+M+CM, B+CD+PWD where CD could represent (CD, DPD, PD, or BD)
3 Color M-Mode (CM)
6 Abdominal includes renal, GYN/Pelvic
7 Intra operative include abdominal, thoracic (cardiac) and vascular (PV)
8 Freehand tissue elasticity
Prescription Use **__**
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C
#### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Shunl Harris
Division Sign Off
Office of In Vitro/Diagnostic Devices Evaluation and Safety 510(K)
#### 510(K) Number (if known):
510(k) Submittal ZONARE Medical Systems, Inc.
Page 1 of
{12}------------------------------------------------
### System Name: ZONARE ZS3 Ultrasound Diagnostic System Device Name: Phase (Sector) Array Transducer P4-1c
Indications for Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Specific<br>(Track I & III) | Mode of Operation | B | M | PWD2 | CWD | Color<br>Doppler3 | Combined<br>Modes4 | Other5 |
|------------------------|------------------------------------------------|-------------------|----|---|------|-----|-------------------|--------------------|--------|
| General | Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | P | P | P | | P | P | P5 |
| | Abdominal6 | | P | P | P | | P | P | P5 |
| | Intra-operative<br>(Specify)7 | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | P | P | P | | P | P | P5 |
| | Small Organ (Thyroid,<br>Breast. Testes, etc.) | | | | | | | | |
| | Neonatal Cephalic | | P | P | P | | P | P | P5 |
| General<br>application | Adult Cephalic/ trans<br>cranial | | P | P | P | | P | P | P5 |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-<br>Card.) | | | | | | | | |
| | Musculo-skel.<br>(Conventional) | | | | | | | | |
| | Musculo-skel.<br>(Superficial) | | | | | | | | |
| | Intra-lumina! | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Cardiac | Cardiac Adult | | P1 | P | P | | P | P | P5 |
| | Cardiac Pediatric | | P | P | P | | P | P | P5 |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Other (Specify)<br>(3D/4D)contrast | | P | P | P | | P | P | P5 |
| Peripheral vascular | Peripheral Vascular | | P | P | P | | P | P | P5 |
| | Other (Specify) | | | | | | | | |
N = new indication; P=previously cleared by the FDA 510(k) K101091. E=Added under Appendix E
1 Includes B-Mode and Harmonic (contrast) imaging (HI)
2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)
3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)
4 Includes B+M, B+M+CM, B+CD+M+CM, B+CD+PWD where CD could represent (CD, DPD, PD, or BD)
5 Color M-Mode (CM)
6 Abdominal includes renal, GYN/Pelvic .
Intra operative include abdominal, thoracic (cardiac) and vascular (PV)
S Freehand tissue elasticity
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Olaung Sheux
on Sign-Office of In Vitro Diagnostic Devices Evaluation and Safe 510(K)
510(K) Number (if known):
510(k) Submittal ZONARE Medical Systems, Inc.
Page 1 of
{13}------------------------------------------------
### System Name: ZONARE ZS3 Ultrasound Diagnostic System Device Name: Phased (Sector) Array Transducer P10-4
Indications for Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | | Mode of Operation | | | | | |
|----------------------------------------------------------------------------------------------|------------------------------------------------|---|-------------------|-----|-----|------------------|-------------------|-------|
| General | Specific<br>(Track I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>Modes | Other |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | P | P | P | | P | P | P |
| | Abdominal | P | P | P | | P | P | P |
| | Intra-operative<br>(Specify) | P | P | P | | P | P | P |
| | Intra-operative (Neuro) | P | P | P | | P | P | P |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | | P | P | P |
| | Small Organ (Thyroid,<br>Breast, Testes, etc.) | | | | | | | |
| | Neonatal Cephalic | P | P | P | | P | P | P |
| General<br>application | Adult Cephalic/ trans<br>cranial | P | P | P | | P | P | P |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-<br>Card.) | | | | | | | |
| | Musculo-skel.<br>(Conventional) | | | | | | | |
| | Musculo-skel.<br>(Superficial) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | P | P | P | | P | P | P |
| | Cardiac Pediatric | P | P | P | | P | P | P |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Other (Specify)<br>(3D/4D) | | | | | | | |
| | Peripheral Vascular | P | P | P | | P | P | P |
| Peripheral vascular | Other (Specify) | | | | | | | |
| N = new indication; P=previously cleared by the FDA 510(k) K101091, E=Added under Appendix E | | | | | | | | |
| 1 Includes B-Mode and Harmonic (contrast) imaging (HI) | | | | | | | | |
2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)
3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)
4 Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent (CD, DPD, PD, or BD)
5 Color M-Mode (CM)
6 Abdominal includes renal, GYN/Pelvic
7 Intra operative include abdominal, thoracic (cardiac) and vascular (PV)
8 Freehand tissue elasticity
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Sammi Harris
Division Sign-Off
Office of In Vitto Diagnostic Devices Evaruation 510(K)
510(K) Number (if known):
510(k) Submittal ZONARE Medical Systems, Inc.
9
Page 1 of
{14}----------------…
