DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
Device Facts
| Record ID | K131830 |
|---|---|
| Device Name | DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM |
| Applicant | Edan Instruments, Inc. |
| Product Code | IYO · Radiology |
| Decision Date | Sep 17, 2013 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1560 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
The diagnostic ultrasound system (DUS 60) is applicable for ultrasound evaluation in hospitals and clinics. It is intended for use in Abdominal; obstetric, gynecology, pediatrics; small parts; urology, peripheral vascular, musculoskeletal (conventional and superficial), and cardiac clinical applications, by or on the order of a physician or similarly qualified health care professional.
Device Story
DUS 60 is a portable diagnostic ultrasound system for use in hospitals and clinics by physicians or qualified professionals. It emits ultrasound waves into body tissue and processes returned echo information to generate images. Key technologies include Phased Inversion Harmonic Compound Imaging (eHCI), Double-Beam-Forming (D Beam), Speckle Resistance Imaging (eSRI), scan receiving aperture (SRA), and Spatial Compounding Imaging. The system supports B, 2B, 4B, M, B+M, and PW modes. It features a 12.1-inch LCD and supports various probes (convex, linear, micro-convex, endocavity). The device automatically detects connected probes. Output is displayed on the monitor for diagnostic analysis, supporting clinical decision-making through real-time imaging and biopsy guidance. Benefits include clear, stable diagnostic visualization of internal structures and blood flow.
Clinical Evidence
No clinical data required. Substantial equivalence established through bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), ultrasonic safety (IEC 60601-2-37), acoustic output testing per FDA guidelines, and biological evaluation (ISO 10993).
Technological Characteristics
Portable ultrasound system with 12.1-inch LCD. Technologies: Phased Inversion Harmonic Compound Imaging, Double-Beam-Forming, Speckle Resistance Imaging, scan receiving aperture, and Spatial Compounding. Supports convex, linear, micro-convex, and endocavity probes. Connectivity: probe auto-detection. Safety standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993. Sterilization: needle-guide brackets match predicate U50.
Indications for Use
Indicated for diagnostic ultrasound imaging or fluid flow analysis in patients requiring abdominal, obstetric, gynecological, pediatric, small parts (including thyroid), urological, peripheral vascular, musculoskeletal, and cardiac evaluations. Contraindications: None stated.
Regulatory Classification
Identification
An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Special Controls
*Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
Predicate Devices
- M5 Diagnostic Ultrasound System (K102991)
- DC-6 Diagnostic Ultrasound System (K072164)
- U50 Diagnostic Ultrasound System (K123249)
Submission Summary (Full Text)
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K13/1830
page 1 of 3
# 510(k) Summary
#### Prepared in accordance with the requirements of 21 CFR Part 807.92
- Edan Instruments. Inc. 1. Submitter:
3/F-B. Nanshan Medical Equipments Park, Nanhai Rd 1019#, Shekou, Nanshan Shenzhen, 518067 P.R. China
EP 1 7 2013
Tel .: +86 75526856469 Fax: +86 75526882223
Contact Person: Cherry Sun
1
June 13th, 2013
Device Name:
2. Device name and classification:
Prepare date:
Digital Ultrasonic Diagnostic Imaging System, Model DUS 60
Classification Name:
System, Imaging, Pulsed echo, Ultrasonic 892.1560
Product code: IYO
Transducer, Ultrasonic. Diagnostic 892.1570
Product code: ITX
Regulatory Class: Class Il
3. Predicate Device:
M5 Diagnostic Ultrasound System K 102991 Manufacturer: Shenzhen Mindrav Bio-Medical Electronics Co., Ltd. DC-6 Diagnostic Ultrasound System K072164 Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd. U50 Diagnostic Ultrasound System. K123249 Manufacturer: SHENZHEN EDAN INSTRUMENTS CO., LTD
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K131830
Page 2 of 3
| 4. Device<br>Description: | The DUS 60 is a portable Diagnostic Ultrasound System, which applies<br>advanced technologies such as Phased Inversion Harmonic Compound<br>Imaging (eHCI), Double-Beam-Forming (D Beam), Speckle Resistance<br>Imaging(eSRI), scan receiving aperture(SRA) and Spatial<br>Compounding Imaging, etc. Various image parameter adjustments, 12.1<br>inch LCD and diverse probes are configured to provide clear and stable<br>images. It is intended for diagnostic ultrasound imaging analysis in<br>hospitals and clinics. |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | It is designed to produce ultrasound waves into body tissue and present<br>the returned echo information on the monitor; which can be displayed in<br>the following modes: B/2B/4B-Mode, M-Mode, B+M Mode or PW<br>Mode. Supported probe types include convex, linear, micro-convex,<br>endocavity (transvaginal, endorectal) probes. The device can detect the<br>probe automatically. |
| | The system consists of 7 major functional blocks, including a main unit,<br>a display subsystem, a transducer and transceiver subsystem, digital<br>beamformer, keyboard and power subsystem. |
| 5. Intended Use: | The diagnostic ultrasound system (DUS 60) is applicable for ultrasound |
evaluation in hospitals and clinics. It is intended for use in Abdominal; obstetric, gynecology, pediatrics; small parts; urology, peripheral vascular, musculoskeletal (conventional and superficial), and cardiac clinical applications, by or on the order of a physician or similarly qualified health care professional.
### 6. Effectiveness and Safety Considerations:
Clinical test:
Clinical testing is not required.
Non-clinical test:
The following safety standards are conducted on the subject device:
(1) IEC 60601-1 Electrical Safety
(2) IEC 60601-1-2 Electromagnetic Compatibility
(3) IEC 60601-2-37 Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
(4) Acoustic output testing as per the guideline "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" dated September 9, 2008.
(5) ISO 10993-1, ISO 10993-5 and ISO 10993-10 Biological evaluation of medical devices
### 7.Comparison to the predicate device
The subject device has same intended use, similar product design, same performance effectiveness, performance safety as the predicate devices. The differences between the subject
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K131830
Page 3 of 3
device and predicate devices do not affect the basic design principle, usage, effectiveness and safety of the subject device. And they don't affect the former's effectiveness and safety.
The subject device has the same needle-guide bracket material, property, and sterilization methods as those of the predicate device U50, therefore, the needle-guide bracket will not cause any safety and effectiveness issues.
### 8. Substantially Equivalent Determination
Verification and validation testing was conducted on the DUS 60 Digital Ultrasonic Diagnostic Imaging System. This premarket notification submission demonstrates that DUS 60 Digital Ultrasonic Diagnostic Imaging System is substantially equivalent to the predicate devices.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three angled shapes that resemble a person with outstretched arms, representing health and well-being.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66 Silver Spring, MD 20993-0002
September 17, 2013
Edan Instruments, Inc. % Ms. Cherry Sun Certification Engineer 3/F - B, Nanshan Medical Equipments Park Nanhai Road 1019#, Shekou, Nanshan Shenzhen, 518067 CHINA
Re: K131830
Trade/Device Name: Digital Ultrasonic Diagnostic Imaging System, Model DUS 60 Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO and ITX Dated: June 7, 2013 Received: June 20, 2013
Dear Ms. Sun:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
This determination of substantial equivalence applies to the following transducers intended for use with the DUS 60 Digital Ultrasonic Diagnostic Imaging System, as described in your premarket notification:
#### Transducer Model Number
| C361-2 | C363-2 | C341-2 |
|--------|--------|--------|
| L741-2 | L743-2 | L761-2 |
| C611-2 | E741-2 | E611-2 |
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If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
hup://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/dcfault.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industrv/default.htm.
Sincerely yours,
Sm.h.7)
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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# Indications for Use Statement
510(k) Number K131830
Device Name: Digital Ultrasonic Diagnostic Imaging System, Model DUS 60
Intended Use:
The diagnostic ultrasound system (DUS 60) is applicable for ultrasound evaluation in hospitals and clinics. It is intended for use in Abdominal; obstetric, gynecology, pediatrics; small parts; urology, peripheral vascular, musculoskeletal (conventional and superficial), and cardiac clinical applications, by or on the order of a physician or similarly qualified health care professional.
| Prescription Use | Or Over the Counter Use |
|-----------------------------|-----------------------------|
| (21 CFR Part 801 Subpart D) | (21 CFR Part 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Smh. 7)
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Number K131830
Page 1 of
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# Diagnostic Ultrasound Indications for Use Form
### DUS 60 Digital Ultrasonic Diagnostic Imaging System |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | |
|-----------------------------|---------------------------------|-------------------|---|----|----|-------|--------------------|-----------------|
| General | Specific | B | M | PW | CW | Color | Combined (Specify) | Other (Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal<br>Imaging<br>& Other | Fetal / Obstetrics | N | N | N | | | N | Note 1,2 |
| | Abdominal | N | N | N | | | N | Note 1.2 |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro logical) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | N | N | N | | | N | Note 1.2 |
| | Small Organ (Specify) * | N | N | N | | | N | Note 1.2 |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | N | N | N | | | N | Note 1,2 |
| | Trans-vaginal | N | N | N | | | N | Note 1,2 |
| | Trans-urethral | | | | | | | |
| | Musculo-skeletal (Conventional) | N | N | N | | | N | Note 1.2 |
| | Musculo-skeletal (Superficial) | N | N | N | | | N | Note 1.2 |
| | Intravascular | | | | | | | |
| | Other (Specify) ** | N | N | N | | | N | Note 1.2 |
| Cardiac | Cardiac | N | N | N | | | N | Note 1,2 |
| | Intravascular(Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra- cardiac | | | | | | | |
| Peripheral<br>vascular | Peripheral vascular | N | N | N | | | N | Note 1,2 |
| | Other (Specify) | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Additional comments: Combined mode: B+M, B+PW
* Small Organ includes thyroid
** Other use includes Urology ________________________________________________________________________________________________________________________________________________
Note 1: Biopsy Guidance
Note 2: Harmonic Imaging. This feature does not use contrast agent. ..........................................................................................................
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Prescription Use (Per 21 CFR 801.109)
the submit and the submit of the subject of the subject of
{7}------------------------------------------------
## Diagnostic Ultrasound Indications for Use Form
### DUS 60 with C361-2 Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Clinical Application | | Mode of Operation | | | | | | |
|-----------------------------|----------------------|---------------------------------|-------------------|---|----|----|-------|--------------------|-----------------|
| | General | Specific | B | M | PW | CW | Color | Combined (Specify) | Other (Specify) |
| Ophthalmic | | Ophthalmic | | | | | | | |
| Fetal<br>Imaging<br>& Other | | Fetal / Obstetrics | N | N | N | | | N | Note 1,2 |
| | | Abdominal | N | N | N | | | N | Note 1.2 |
| | | Intra-operative (Specify) | | | | | | | |
| | | Intra-operative (Neuro logical) | | | | | | | |
| | | Laparoscopic | | | | | | | |
| | | Pediatric | | | | | | | |
| | | Small Organ (Specify) * | | | | | | | |
| | | Neonatal Cephalic | | | | | | | |
| | | Adult Cephalic | | | | | | | |
| | | Trans-rectal | | | | | | | |
| | | Trans-vaginal | | | | | | | |
| | | Trans-urethral | | | | | | | |
| | | Musculo-skeletal (Conventional) | | | | | | | |
| | | Musculo-skeletal (Superficial) | | | | | | | |
| | | Intravascular | | | | | | | |
| | | Other (Specify) ** | N | N | N | | | N | Note 1,2 |
| Cardiac | | Cardiac | | | | | | | |
| | | Intravascular(Cardiac) | | | | | | | |
| | | Trans-esoph. (Cardiac) | | | | | | | |
| | | Intra- cardiac | | | | | | | |
| Peripheral<br>vascular | | Peripheral vascular | | | | | | | |
| | | Other (Specify) | | | | | | | |
N = new indication: P = previously cleared by FDA: E = added under this appendix
Additional comments: Combined mode: B+M, B+PW
* Small Organ includes thyroid
** Other use includes Urology ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Note 1: Biopsy Guidance ្រី នាន មួយច្រើន ស្រុក ស្រុក ក្រោយ ស្រុក ក្រោយ ស្រុក ក្រោយ និង ប្រយោជន៍ និង ប្រ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Note 2: Harmonic Imaging. This feature does not use contrast agent ...........................................................................................................
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) Prescription Use (Per 21 CFR 801.109)
{8}------------------------------------------------
# Diagnostic Ultrasound Indications for Use Form
#### DUS 60 with C363-2 Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | |
|-----------------------------|---------------------------------|-------------------|---|----|----|-------|-----------------------|--------------------|
| General | Specific | B | M | PW | CW | Color | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal<br>Imaging<br>& Other | Fetal / Obstetrics | N | N | N | | | N | Note 1,2 |
| | Abdominal | N | N | N | | | N | Note 1,2 |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro logical) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Specify) * | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Musculo-skeletal(Conventional) | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) ** | N | N | N | | | N | Note 1,2 |
| Cardiac | Cardiac | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | |
| | Intra- cardiac | | | | | | | |
| Peripheral<br>vascular | Peripheral vascular | | | | | | | |
| | Other (Specify) | | | | | | | |
N = new indication; P = previously cleared by FDA: E = added under this appendix
Additional comments: Combined mode: B+M, B+PW
* Small Organ includes thyroid
** Other use includes Urology ................................................................................................................................................
Note 1: Biopsy Guidance
Note 2: Harmonic Imaging, This feature does not use contrast agent - - - t man
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
Prescription Use (Per 21 CFR 801.109)
{9}------------------------------------------------
# Diagnostic Ultrasound Indications for Use Form
### DUS 60 with C341-2 Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | | | |
|----------------------|---------------------------------|-------------------|---|----|----|-------|-----------------------|--------------------|--|--|
| General | Specific | િ | M | PW | CW | Color | Combined<br>(Specify) | Other<br>(Specify) | | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| | Fetal / Obstetrics | N | N | N | | | N | Note 1,2 | | |
| | Abdominal | N | N | N | | | N | Note 1.2 | | |
| | Intra-operative (Specify) | | | | | | | | | |
| | Intra-operative (Neuro logical) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | | | | | | | | | |
| | Small Organ (Specify) * | | | | | | | | | |
| Fetal | Neonatal Cephalic | | | | | | | | | |
| Imaging<br>& Other | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Musculo-skeletal(Conventional) | | | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | | | |
| | Intravascular | | | | | | | | | |
| | Other (Specify) ** | N | N | N | | | N | Note 1.2 | | |
| | Cardiac | | | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | | | |
| Cardiac | Trans-esoph.(Cardiac) | | | | | | | | | |
| | Intra- cardiac | | | | | | | | | |
| Peripheral | Peripheral vascular | | | | | | | | | |
| vascular | Other (Specify) | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional comments: Combined mode: B+M, B+PW
* Small Organ includes thyroid ______________________________________________________________________________________________________________________________________________________________________________
** Other use includes Urology ------------------------------------------------------------------------------------------------------------------------------------------------
______________________________________________________________________________________________________________________________________________________________________________
Note 2: Harmonic Imaging, This feature does not use contrast agent
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Prescription Use (Per 21 CFR 801.109)
.
{10}------------------------------------------------
# Diagnostic Ultrasound Indications for Use Form
### DUS 60 with L741-2 Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | |
|-----------------------------|---------------------------------|-------------------|---|----|----|-------|-----------------------|--------------------|
| General | Specific | B | M | PW | CW | Color | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal / Obstetrics | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro logical) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| Fetal<br>Imaging<br>& Other | Small Organ (Specify) * | N | N | N | | | N | Note 1.2 |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Musculo-skeletal(Conventional) | N | N | N | | | N | Note 1.2 |
| | Musculo-skeletal (Superficial) | N | N | N | | | N | Note 1.2 |
| | Intravascular | | | | | | | |
| | Other (Specify) ** | | | | | | | |
| Cardiac | Cardiac | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra- cardiac | | | | | | | |
| Peripheral<br>vascular | Peripheral vascular | N | N | N | | | N | Note 1.2 |
| | Other (Specify) | | | | | | | |
N = new indication; P = previously cleared by FDA: E = added under this appendix
Additional comments: Combined mode: B+M. B+PW
* Small Organ includes thyroid
| | | | ** Other use includes Urology | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | and and the commend of the comments of the comments of the comments of the comments of | | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |
Note 1: Biopsy Guidance
Note 2: Harmonic Imaging, This feature does not use contrast agent
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEFIDED)
Concurrence of CDRH, Office of in Vitro Diagnostic Device Evaluation and Safety (OIVD)
Prescription Use (Per 21 CFR 801.109)
6
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------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
{11}------------------------------------------------
# Diagnostic Ultrasound Indications for Use Form
### DUS 60 with L743-2 Transducer
Intended Use: Diagnostic ultrasound imaging or thaid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | | | |
|----------------------|---------------------------------|-------------------|-----|----|----|-------|-----------------------|--------------------|--|--|
| General | Specific | B | M . | PW | CW | Color | Combined<br>(Specify) | Other<br>(Specify) | | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| | | | | | | | | | | |
| | Fetal / Obstetrics | | | | | | | | | |
| | Abdominal | | | | | | | | | |
| | Intra-operative (Specify) | | | | | | | | | |
| | Intra-operative (Neuro logical) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | | | | | | | | | |
| | Small Organ (Specify) * | N | N | N | | | N | Note 1.2 | | |
| Fetal | Neonatal Cephalic | | | | | | | | | |
| İmaging | Adult Cephalic | | | | | | | | | |
| & Other | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Musculo-skeletal(Conventional) | N | N | N | | | N | Note 1.2 | | |
| | Musculo-skeletal (Superficial) | N | N | N | | | N | Note 1.2 | | |
| | Intravascular | | | | | | | | | |
| | Other (Specify) ** | | | | | | | | | |
| | Cardiac | | | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | | | |
| Cardiac | Trans-esoph.(Cardiac) | | | | | | | | | |
| | Intra- cardiac | | | | | | | | | |
| Peripheral | Peripheral vascular | N | N | N | | | N | Note 1.2 | | |
| vascular | Other (Specify) | | | | | | | | | |
N = new indication: P = previously cleared by FDA; E = added under this appendix
Additional comments: Combined mode: B+M. B+PW
* Small Organ includes thyroid
** Other use includes Urology
Note 1: Biopsy Guidance
Note 2: Harmonic Imaging. This feature does not use contrast agent
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Prescription Use (Per 21 CFR 801.109)
7
{12}------------------------------------------------
# Diagnostic Ultrasound Indications for Use Form
### DUS 60 with L761-2 Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | | |
|-----------------------------|---------------------------------|-------------------|---|----|----|-------|-----------------------|--------------------|--|
| General | Specific | B | M | PW | CW | Color | Combined<br>(Specify) | Other<br>(Specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal<br>Imaging<br>& Other | Fetal / Obstetrics | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neuro logical) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (Specify) * | N | N | N | | | N | Note 1.2 | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Musculo-skeletal(Conventional) | N | N | N | | | N | Note 1,2 | |
| | Musculo-skeletal (Superficial) | N | N | N | | | N | Note 1.2 | |
| | Intravascular | | | | | | | | |
| | Other (Specify) ** | | | | | | | | |
| Cardiac | Cardiac | | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | | |
| | Intra- cardiac | | | | | | | | |
| Peripheral<br>vascular | Peripheral vascular | N | N | N | | | N | Note 1,2 | |
| | Other (Specify) | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional comments: Combined mode: B+M, B+PW
* Small Organ includes thyroid
** Other use includes Urology
______________________________________________________________________________________________________________________________________________________________________________
Note 2: Harmonic Imaging, This feature does not use contrast agent
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEFDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Prescription Use (Per 21 CFR 801.109)
8
{13}------------------------------------------------
# Diagnostic Ultrasound Indications for Use Form
### DUS 60 with C611-2 Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | |
|-----------------------------|---------------------------------|-------------------|---|----|----|-------|--------------------|-----------------|
| General | Specific | B | M | PW | CW | Color | Combined (Specify) | Other (Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal<br>Imaging<br>& Other | Fetal / Obstetrics | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro logical) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | N | N | N | | | N | Note 1,2 |
| | Small Organ (Specify) * | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Musculo-skeletal(Conventional) | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) ** | | | | | | | |
| Cardiac | Cardiac | N | N | N | | | N | Note 1,2 |
| | Intravascular(Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | |
| | Intra- cardiac | | | | | | | |
| Peripheral<br>vascular | Peripheral vascular | | | | | | | |
| | Other (Specify) | | | | | | | |
N = new indication: P = previously cleared by FDA: E = added under this appendix
Additional comments: Combined mode: B+M, B+PW
* Small Organ includes thyroid
** Other use includes Urology
Note 1: Biopsy Guidance
· · Note 2: Harmonic Imaging, This feature does not use contrast agent
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Prescription Use (Per 21 CFR 801.109)
{14}------------------------------------------------
# Diagnostic Ultrasound Indications for Use Form
### DUS 60 with E741-2 Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | |
|-----------------------------|---------------------------------|-------------------|---|----|----|-------|-----------------------|--------------------|
| General | Specific | B | M | PW | CW | Color | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal<br>Imaging<br>& Other | Fetal / Obstetrics | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro logical) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Specify) * | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | N | N | N | | | N | Note 1.2 |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Musculo-skeletal(Conventional) | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) ** | | | | | | | |
| Cardiac | Cardiac | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | |
| | Intra- cardiac | | | | | | | |
| Peripheral<br>vascular | Peripheral vascular | | | | | | | |
| | Other (Specify) | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional comments: Combined mode: B+M, B+PW
* Small Organ includes thyroid
** Other use includes Urology ________________________________________________________________________________________________________________________________________________
Note 1: Biopsy Guidance ______________________________________________________________________________________________________________________________________________________________________________
Note 2: Harmonic Imaging, This feature does not use contrast agent
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Prescription Use (Per 21 CFR 801.109)
{15}------------------------------------------------
# Diagnostic Ultrasound Indications for Use Form
### DUS 60 with E611-2 Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | |
|-----------------------------|---------------------------------|-------------------|---|----|----|-------|-----------------------|--------------------|
| General | Specific | B | M | PW | CW | Color | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal<br>Imaging<br>& Other | Fetal / Obstetrics | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro logical) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Specify) * | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | N | N | N | | | N | Note 1,2 |
| | Trans-vaginal | N | N | N | | | N | Note 1,2 |
| | Trans-urethral | | | | | | | |
| | Musculo-skeletal (Conventional) | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) ** | | | | | | | |
| Cardiac | Cardiac | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | |
| | Intra- cardiac | | | | | | | |
| Peripheral | Peripheral vascular | | | | | | | |
| vascular | Other (Specify) | | | | | | | |
N = new indication: P = previously cleared by FDA: E = added under this appendix
Additional comments: Combined mode: B+M. B+PW
* Small Organ includes thyroid
** Other use includes Urology
Note 1: Biopsy Guidance
Note 2: Harmonic Imaging, This feature does not use contrast agent
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Prescription Use (Per 21 CFR 801.109)
