Sonosite PX Ultrasound System
Device Facts
| Record ID | K213763 |
|---|---|
| Device Name | Sonosite PX Ultrasound System |
| Applicant | FUJIFILM Sonosite, Inc. |
| Product Code | IYN · Radiology |
| Decision Date | Dec 27, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric, 3rd-Party Reviewed |
Indications for Use
The Sonosite PX Ultrasound System is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging of the human body. Specific clinical applications and exam types include: Abdominal Adult cephalic Cardiac Adult Cardiac Pediatric Fetal - OB/GYN Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Ophthalmic Pediatric Peripheral Vessel Small Organ (breast, thyroid, testicles, prostate) Transvaginal Transesophageal (cardiac) Transrectal Needle Guidance Modes of operation include: B Mode (B), M-Mode (M) (including simultaneous M-mode and anatomical M-Mode), PW Doppler Mode (B), M-Mode (M) (Including simultaneo (PWD) (including Pulsed Wave Tissue Doppler), Continuous Wave Doppler (including Velocity Color Dopler), Tissue Harmonic Imaging (THI), Tissue Dopler Imaging (TDI), and Combined modes, including Triplex imaging: B+M, B+PWD, B+CWD, B+C, (B+C)+PWD, (B+C)+CWD This device is indicated for Prescription Use Only. The Sonosite PX Ultrasound System is intended to be used in medical practices, clinical environments, including Healthcare facilities, Hospitals, Clinics and clinical point-of-care for diagnosis of patients.
Device Story
Sonosite PX is a general-purpose, software-controlled diagnostic ultrasound system. It acquires and displays real-time 2D, M-Mode, PW/CW Doppler, and Color Power Doppler data. Used in hospitals, clinics, and point-of-care settings by physicians and healthcare professionals. Input consists of ultrasound signals from various transducers; system processes these to generate high-resolution images and fluid flow analysis. Features include Anatomical M-Mode (AMM), speckle reduction, image compounding, and a non-diagnostic ECG module for cardiac signal synchronization. Output is displayed on a 19-inch LED monitor; clinicians use these images for diagnostic evaluation. Includes Qview for communication with QPathE reporting software. Benefits include enhanced diagnostic visualization and workflow customization. System operates on battery or AC power.
Clinical Evidence
No clinical data. Substantial equivalence supported by bench testing, including electrical, thermal, mechanical, and EMC safety, biocompatibility, and acoustic output characterization.
Technological Characteristics
System uses 128 digital transmit/receive channels. Features 12.1" capacitive touch interface and 19" LED LCD monitor. Transducers include linear, curved, phased, intracavitary, and trans-esophageal arrays (1.0-19.0 MHz). Connectivity includes USB 3.0/2.0, DICOM 3.0, and 802.11 wireless. Software includes speckle reduction and image compounding. Patient contact materials (silicone, PVC, ABS, etc.) tested per ISO 10993-1. Complies with IEC 60601-1, IEC 60601-2-37, and IEC 62359.
Indications for Use
Indicated for qualified physicians and healthcare professionals for ultrasound imaging or fluid flow analysis of the human body. Applications include abdominal, adult cephalic, cardiac (adult/pediatric), fetal OB/GYN, musculoskeletal, ophthalmic, pediatric, peripheral vessel, small organ, transvaginal, transesophageal, and transrectal exams. Prescription use only.
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
- Sonosite PX Ultrasound System (K200964)
Reference Devices
- SonoSite Edge II Ultrasound System (K162045)
- TEExi transducer (K153626)
- C35x transducer (K200964/K162045)
- OEM Needle Guide (K093713)
Submission Summary (Full Text)
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December 27, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
FUJIFILM Sonosite, Inc. % Prithul Bom Responsible Third Party Official Regulatory Technology Services, LLC 1000 Westgate Drive, Suite #510k SAINT PAUL MN 55114
Re: K213763
Trade/Device Name: Sonosite PX Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX, OIJ Dated: November 30, 2021 Received: December 1, 2021
Dear Prithul Bom:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Jessica Lamb, Ph.D. Assistant Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K213763
#### Device Name Sonosite PX Ultrasound System
#### Indications for Use (Describe)
The Sonosite PX Ultrasound System is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging of the human body. Specific clinical applications and exam types include:
| Abdominal |
|----------------------------------------------------|
| Adult cephalic |
| Cardiac Adult |
| Cardiac Pediatric |
| Fetal - OB/GYN |
| Musculo-skeletal (Conventional) |
| Musculo-skeletal (Superficial) |
| Ophthalmic |
| Pediatric |
| Peripheral Vessel |
| Small Organ (breast, thyroid, testicles, prostate) |
| Transvaginal |
| Transesophageal (cardiac) |
| Transrectal |
| Needle Guidance |
Modes of operation include: B Mode (B), M-Mode (M) (including simultaneous M-mode and anatomical M-Mode), PW Doppler
Mode (B), M-Mode (M) (Including simultaneo (PWD) (including Pulsed Wave Tissue Doppler), Continuous Wave Doppler (including Velocity Color Dopler), Tissue Harmonic Imaging (THI), Tissue Dopler Imaging (TDI), and Combined modes, including Triplex imaging: B+M, B+PWD, B+CWD, B+C, (B+C)+PWD, (B+C)+CWD
This device is indicated for Prescription Use Only.
The Sonosite PX Ultrasound System is intended to be used in medical practices, clinical environments, including Healthcare facilities, Hospitals, Clinics and clinical point-of-care for diagnosis of patients.
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|
> Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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# 510(K) Summary
This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with 21 CFR, Part 807, Subpart E, Section 807.92.
#### 1) Submitter:
| Manufacturer Name:<br>Address: | FUJIFILM SonoSite, Inc.<br>21919 30th Drive SE<br>Bothell, WA 98021-3904 |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Corresponding Official: | Anoush Frankian |
| | Sr. Manager, Regulatory Affairs |
| E-mail: | anoush.frankian@fujifilm.com |
| Telephone: | (425) 951-6824 |
| Facsimile: | (425) 951-1201 |
| Date prepared: | October 18, 2021 |
| Regulatory Lead &<br>Alternate Contact: | Medha Sateesh Bharadwaj |
| E-mail: | medha.bharadwaj@fujifilm.com |
| Telephone: | (631) 532-7229 |
| Facsimile: | (425) 951-1201 |
| 2) Device | |
| Trade Name: | Sonosite PX Ultrasound System |
| Common Name: | Diagnostic Ultrasound System and Transducers with<br>Accessories |
| Regulation Name: | Ultrasonic Pulsed Doppler Imaging System<br>Ultrasonic Pulsed Echo Imaging System<br>Diagnostic Ultrasound Transducer |
| Regulation Number: | 21 CFR 892.1550<br>21 CFR 892.1560<br>21 CFR 892.1570 |
| Primary Product Code: | IYN |
| Secondary Product Codes: | IYO<br>ITX<br>OIJ |
| Device Class: | Class II |
| Classification Panel: | Radiology |
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# 3) Predicate Device:
Primary Predicate: Sonosite PX Ultrasound System (K200964)
Reference Device: SonoSite Edge II Ultrasound System (K162045)
# 4) Device Description:
The Sonosite PX Ultrasound System is a full featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data in 2D, M-Mode (including Simultaneous M-Mode and anatomical M-Mode), Pulsed Wave (PW) Doppler (including Pulsed Wave Tissue Doppler), Continuous Wave (CW) Doppler, Color Power Doppler (including Velocity Color Doppler), Tissue Harmonic Imaging or in a combination of these modes. including Triplex imaging.
The system includes a variety of accessories including optional needle guide starter kits. The system also includes an ECG-specific port to support the ECG feature. The non-diagnostic ECG module provides ECG tracing of the cardiac signal synchronized with the ultrasound image.
# 5) Intended Use/Indications for Use:
The Sonosite PX Ultrasound System is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include:
Abdominal Adult Cephalic Cardiac Adult Cardiac Pediatric Fetal - OB/GYN Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Ophthalmic Pediatric Peripheral vessel Small Organ (breast, thyroid, testicles, prostate) Transvaginal Transesophageal (cardiac) Transrectal Needle Guidance
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Modes of operation include: B Mode (M) (including simultaneous M-mode and anatomical M-Mode), PW Doppler (PWD) (including Pulsed Wave Tissue Doppler), Continuous Wave Doppler (CWD), Color Power Doppler (including Velocity Color Doppler), Tissue Harmonic Imaging (THI), Tissue Doppler Imaging (TDI), and Combined modes, including Triplex imaging: B+M, B+PWD, B+CWD, B+C, (B+C)+PWD, (B+C)+CWD
This device is indicated for Prescription Use Only.
The Sonosite PX Ultrasound System is intended to be used in medical practices, clinical environments, including Healthcare facilities, Hospitals, Clinics and clinical point-of-care for diagnosis of patients.
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# 6) Technological Characteristics:
The Sonosite PX Ultrasound System, subject device of this submission, is equivalent to the previously cleared Sonosite PX (K20096) and Edge II (K162045) Ultrasound Systems in terms of both the intended use and technological characteristics. The Sonosite PX (subject device) uses the same fundamental scientific technology as the predicate device.
| Feature | Sonosite PX Ultrasound<br>System | Sonosite PX Ultrasound<br>System | SonoSite Edge II Ultrasound<br>System | Evaluation of<br>Differences |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | (This submission) | (K200964) | (K162045) | |
| Intended Use | Diagnostic ultrasound imaging or<br>fluid flow analysis of the human<br>body | Diagnostic ultrasound<br>imaging or fluid flow analysis<br>of the human body | Diagnostic ultrasound imaging or<br>fluid flow analysis of the human<br>body | The intended use of<br>the Sonosite PX is<br>identical to the<br>predicate and<br>reference devices. |
| Indications for<br>Use | Abdominal<br>Adult Cephalic<br>Cardiac Adult<br>Cardiac<br>Pediatric<br>Fetal - OB/GYN<br>Musculo-skeletal<br>(Conventional)<br>Musculo-skeletal<br>(Superficial)<br>Ophthalmic<br>Pediatric<br>Small Organ (breast, thyroid,<br>testicle, prostate)<br>Transvaginal<br>Peripheral Vessel<br>Trans-Rectal<br>Trans-esophageal (cardiac)<br>Needle guidance | Abdominal<br>Adult Cephalic<br>Cardiac Adult<br>Cardiac<br>Pediatric<br>Fetal - OB/GYN<br>Musculo-skeletal<br>(Conventional)<br>Musculo-skeletal<br>(Superficial)<br>Ophthalmic<br>Pediatric<br>Small Organ (breast, thyroid,<br>testicle, prostate)<br>Peripheral Vessel<br>Transvaginal<br>Needle guidance | Abdominal<br>Adult<br>Cephalic<br>Cardiac Adult<br>Cardiac Pediatric<br>Fetal - OB/GYN<br>Musculo-skeletal<br>(Conventional)<br>Musculo-skeletal<br>(Superficial)<br>Ophthalmic<br>Pediatric<br>Small Organ (breast, thyroid,<br>testicle, prostate)<br>Transvaginal<br>Peripheral Vessel<br>Needle guidance<br>Neonatal<br>Cephalic<br>Trans-Rectal<br>Trans-esophageal (cardiac)<br>Needle guidance | The Indications for<br>Use are a subset of<br>Sonosite PX<br>Ultrasound system<br>(primary predicate-<br>K200964) and<br>Sonosite Edge II<br>Ultrasound system<br>(reference device-<br>K162045). |
| Transducer<br>Types | Linear Array<br>Curved Linear<br>Array Phased Array<br>Intracavitary<br>Trans-esophageal | Linear Array<br>Curved Linear<br>Array Phased Array<br>Intracavitary | Linear Array<br>Curved Linear Array<br>Phased Array<br>Intracavitary<br>Trans-esophageal | Transducer types for<br>Sonosite PX are all a<br>subset of Sonosite<br>PX Ultrasound<br>system (primary<br>predicate) and<br>Sonosite Edge II<br>Ultrasound system<br>(reference<br>device). |
| Transducer<br>Frequency | 1.0-19.0 MHz | 1.0-19.0 MHz | 1.0 - 15.0 MHz | The frequency range<br>for Sonosite PX is<br>unchanged and the<br>same as the primary<br>predicate Sonosite PX<br>(K200964) |
| Global | Ispta.3: 607 mW/cm^2 | Ispta.3: 607 mW/cm^2 | Ispta.3: 598.9 | Acoustic output is |
| Maximum<br>Outputs/Worst<br>Case Setting | (L12-3)<br>TI Type: TIB (P5-1)<br>TI Value: 4.87 (P5-1)<br>MI: 1.72 (L12-3)<br>Ipa.3@MI Max: 793<br>mW/cm^2 (L15-4) | (L12-3)<br>TI Type: TIB (P5-1)<br>TI Value: 4.87 (P5-<br>1) MI: 1.72 (L12-3)<br>Ipa.3@MI Max: 793 mW/cm^2<br>(L15-4) | (HFL50x)<br>TI Type: TIB<br>(rP19x)<br>TI Value: 4.98<br>(rP19x) MI: 1.7<br>(rP19x)<br>Ipa.3@MI Max: 776 (L38xi) | less than FDA<br>established limits. |
| Acoustic<br>Output Display<br>& FDA Limits | Display Feature for Higher<br>Outputs MI Output Display<br>TI Output Display | Display Feature for Higher<br>Outputs MI Output Display<br>TI Output Display | Display Feature for Higher<br>Outputs MI Output Display<br>TI Output Display | MI & TI are always<br>displayed and a power<br>management system<br>ensures that they<br>never exceed the<br>derated FDA limits. |
| Modes of<br>Operation | | | | |
| | B-mode Grayscale<br>Imaging | B-mode Grayscale Imaging | B-mode Grayscale Imaging | Modes of operation<br>are a subset of<br>Sonosite PX<br>Ultrasound system<br>(primary predicate)<br>and Sonosite Edge II<br>Ultrasound system<br>(reference device).<br>The AMM imaging<br>frame and transmit<br>sequence is identical<br>to regular<br>simultaneous 2D/M-<br>mode as seen on<br>predicate device<br>Sonosite PX<br>(K200964). The only<br>difference is the AMM<br>line is extracted from<br>the 2D image data<br>based on the AMM<br>line position the user<br>specified and the<br>display in the sweep<br>field of view. |
| | Tissue Harmonic Imaging | Tissue Harmonic Imaging | Tissue Harmonic Imaging | |
| | M-mode<br>Simultaneous M- Mode<br>AMM | M-mode<br>Simultaneous M- Mode | M-mode Color M-Mode | |
| | Color Power Doppler<br>Zoom | Color Power Doppler Zoom | Color Power Doppler Zoom | |
| | Combination Modes<br>Pulsed Wave (PW)<br>Doppler | Combination Modes Pulsed<br>Wave (PW) Doppler | Combination Modes<br>Pulsed Wave (PW) Doppler | |
| | Continuous Wave (CW)<br>Doppler | Continuous Wave (CW)<br>Doppler | Continuous Wave (CW)<br>Doppler | |
| | Speckle reduction algorithm<br>(formerly branded as<br>SonoHD2 Noise Reduction) | Speckle reduction algorithm<br>(formerly branded as<br>SonoHD2 Noise Reduction) | SonoHD2 Noise Reduction | |
| | SonoMB/MBe Image<br>Compounding | SonoMB/MBe Image<br>Compounding | SonoMB/MBe Image<br>Compounding | |
| | CW Doppler<br>Velocity Color Doppler Tissue<br>Doppler Imaging (TDI) | CW Doppler<br>Velocity Color Doppler<br>Tissue Doppler Imaging<br>(TDI) | Steered CW Doppler Velocity<br>Color Doppler<br>Tissue Doppler Imaging (TDI) | |
| DICOM | DICOM 3.0<br>Store and Offline Media | DICOM 3.0 Store, Print,<br>Modality Worklist, Perform<br>Procedure Step(PPS),<br>Storage Commitment | DICOM 3.0 Store, Print,<br>Modality Worklist, Perform<br>ProcedureStep (PPS),<br>Storage Commitment | Includes a subset<br>of thisinformation |
| #Transmit<br>Channels | 128 digital channels | 128 digital channels | 128 digital channels | - |
| #Receive<br>Channels | 128 digital channels | 64 digital channels<br>(128 digital channels<br>usingSynthetic<br>Aperture) | 64 digital channels<br>(128 digital channels using<br>Synthetic Aperture) | - |
| Patient<br>Contact<br>Materials | Transducers:<br>Silicone Rubber<br>Polysulfone<br>Poly Vinyl Chloride<br>(PVC)<br>Silicone RTV Adhesive<br>Silicone<br>Polymethyl-pentene Epoxy<br>Paste Adhesive<br>Polyurethane<br>FKM rubber<br>Thermoplastic<br>polyurethane<br>Needle Guides: Acetal<br>copolymer Acrylonitrile-<br>butadien-<br>styrene (ABS) | Transducers:<br>Silicone<br>Rubber<br>Polysulfon<br>e UDEL<br>P1700<br>Poly Vinyl Chloride<br>(PVC)Silicone RTV<br>Adhesive Silicone<br>Needle Guides:<br>Acetal copolymer<br>Acrylonitrile-butadien-styrene<br>(ABS) | Transducers:<br>Acrylonitrile-butadien- styrene<br>(ABS) Cycoloy Epoxy paste<br>adhesive Polyethylene (PE)<br>lonomer Polyetheretherketone<br>(PEEK)Polycarbonate<br>Polysulfone<br>UDEL<br>Polyurethane<br>Poly Vinyl Chloride (PVC)<br>Silicone RTV Adhesive<br>Silicone Rubber Urethane<br>Needle Guides:<br>Acetal copolymer Acrylonitrile-<br>butadien-styrene<br>(ABS) | All patient contact<br>materials have been<br>testedto ISO 10993-1.<br><br>Materials used in<br>SonositePX have<br>undergone identical<br>biocompatibility and<br>cleaning/disinfection<br>testing to the<br>predicate devices.<br><br>Bio-compatibility<br>summary test results<br>are provided in<br>D00414, Bio-<br>compatibility Test<br>Report, included in<br>Attachment 6 ofthis<br>submission. |
| Product<br>Safety<br>Certification | AAMI/ANSI ES60601-<br>1:2005 (R2012)<br><br>IEC 60601-2-<br>37:2007+AMD 1:2015<br><br>CAN/CSA-C22.2 No.<br>60601-1:14 JSA JIS T<br>0601-1:2017,<br>JSA JIS T 0601-2-37 IEC<br>61157:2007+AMD1:2013 | AAMI/ANSI ES60601-1:2005<br>(R2012<br><br>IEC 60601-2-<br>37:2007+AMD 1:2015<br><br>CAN/CSA-C22.2 No. 60601-1:14<br>JSAJIS T 0601-1:2017,<br>JSA JIS T 0601-2-37<br>IEC 61157:2007+AMD1:2013 | AAMI/ANSI ES60601-<br>1:2005 (R2012)<br>IEC 60601-2-37:<br>2007<br>CAN/CSA C22.2 No. 60601-<br>1:08<br>NEMA UD2-2004 IEC<br>62359:2010 | |
| | IEC 62359:2010+AMD1:2017 | NEMA UD 2-2004 (R2009)<br>IEC 62359:2010+AMD1:2017 | | |
| EMC<br>Compliance | IEC 60601-1-2:2014<br>CISPR 11:2015+AMD1:2016<br>+AMD2:2019 IEC<br>61000-4-2.<br>IEC 61000-4-3<br>IEC 61000-4-4.<br>IEC 61000-4-5<br>IEC 61000-4-6.<br>IEC 61000-4-8<br>IEC 61000-4-11 | IEC 60601-1-2:2014<br>CISPR 11:2015+AMD1:2016<br>+AMD2<br>IEC 61000-4-2.<br>IEC 61000-4-3<br>IEC 61000-4-4.<br>IEC 61000-4-5<br>IEC 61000-4-6.<br>IEC 61000-4-8<br>IEC 61000-4-11 | AAMI / ANSI / IEC 60601-1-<br>2:2007(R)2012 CISPR 11,<br>Group 1,<br>Class A | |
| DICOM | DICOM PS3.15 2011 | NEMA PS3.15 2003 | NEMA PS3.15 2003 | |
| Airborne<br>Equipment<br>Standards | none applied | none applied | RTCA/DO160 (section 21) | Airborne<br>equipment<br>standards have<br>not been applied<br>to the Sonosite<br>PXultrasound<br>system and<br>labeling will not claim<br>to this. |
| System | Sonosite PX: | Sonosite PX: | Edge II: | Sonosite PX 2.0 |
| Characteristics | Beamformer 128/128 using<br>SA (configurable)<br>12.1" Capacitive touch<br>screen interface<br>19" LED LCD HD monitor<br>256 gray shades on LED LCD | Beamformer 128/128 using<br>SA (configurable)<br>12.1" Capacitive touch<br>screen interface<br>19" LED LCD HD monitor<br>256 gray shades on LED LCD | Beamformer 128/128<br>using SA (configurable)<br>Hand held display and control<br>Single 12.1" Liquid Crystal<br>Display (LCD)<br>256 gray shades on LCD2 | includes a non-<br>diagnostic ECG<br>module.Like<br>reference device<br>Edge II ultrasound<br>system (K162045),<br>this module<br>provides ECG<br>tracing of the |
| | 2 USB 3.0<br>4 USB 2.0 | 2 USB 3.0<br>4 USB 2.0 | USB ports | cardiac signal<br>synchronized with<br>the ultrasound |
| | Stand Base Dimensions:<br>26.4" L x 21.2" W<br>Stand Height (max): 64"<br>(monitor up)<br>Stand Height (min): 42.2"<br>(monitor down)<br>Weight: 149.35 lbs (fully<br>configured w/ 3 transducers<br>and stand base<br>Weight: 32.80 lbs<br>(w/ 1 transducer) | Stand Base Dimensions:<br>26.4" L x 21.2" W<br>Stand Height (max): 64"<br>(monitor up)<br>Stand Height (min): 42.2"<br>(monitor down)<br>Weight: 149.35 lbs (fully<br>configured w/ 3 transducers<br>and stand base<br>Weight: 32.80 lbs (w/1<br>transducer) | Dimensions: 12.8"(W) x<br>12.1" (L) x 2.5"(H)<br>Weight: 9.0 lbs | image. |
| | System operates via battery<br>or AC power | System operates via battery<br>or AC power | System operates via<br>battery or AC power | |
| | Battery life: 1 hour imaging<br>- 10 days idle | Battery life: 1 hour imaging -<br>10 days idle | Battery life: 1.5 - 4 hour<br>operation per charge | |
| | Input: 100 - 240 VAC, 50/60<br>Hz<br>Output 1: 26.7VDC output,<br>220 W max<br>System on stand: | Input: 100 - 240 VAC, 50/60<br>Hz<br>Output 1: 26.7VDC output, 220<br>W max<br>System on stand: | 100 - 240V options, 50/60Hz,<br>15VDC output | |
| | Input: 100 - 240 VAC, 50/60<br>Hz<br>Output 1: 26.7VDC output,<br>220 W max<br>Output 2: 100-240VAC, 50-60<br>Hz<br>(AC Printer) | Input: 100 - 240 VAC, 50/60<br>Hz<br>Output 1: 26.7VDC output, 220<br>W max<br>Output 2: 100-240VAC, 50-60<br>Hz<br>(AC Printer) | | |
| | Various obstetrical, cardiac,<br>volume, M-mode,PW and<br>CW Doppler measurement<br>and calculation packages | Various obstetrical,<br>cardiac, volume, M-mode,<br>PW and CW Doppler<br>measurement and<br>calculation packages | Various obstetrical, cardiac,<br>volume, M- mode, PW and CW<br>Doppler measurement and<br>calculation packages | |
| | Non-diagnostic ECG tracing | | Non-diagnostic ECG tracing,<br>CW/PW Doppler Audio Spectral<br>Doppler Audio<br>and image storage on<br>removable media | |
| | Wireless 802.11 (a/b/g/n) | Wireless 802.11<br>(a/b/g/n) support for<br>image transfer | Wireless 802.11 (b/g/n) support<br>for image transfer | |
| | Additional system features:<br>Assisted CardiacOutput (ACO) -<br>Available on Sonosite PX<br>system | Additional system features:<br>Assisted Cardiac Output (ACO)<br>- Available on<br>Sonosite PX system…
