Who is the manufacturer of Sonosite PX Ultrasound System?

FUJIFILM Sonosite, Inc. filed the 510(k) submission for Sonosite PX Ultrasound System (K213763).

What is the FDA product code for Sonosite PX Ultrasound System?

IYN. It is classified under 21 CFR 892.1550 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for Sonosite PX Ultrasound System?

510(k) clearance (submission type: Traditional).

Does Sonosite PX Ultrasound System use AI or machine learning?

Yes. Sonosite PX Ultrasound System (K213763) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

Who can help prepare an FDA 510(k) submission like Sonosite PX Ultrasound System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like Sonosite PX Ultrasound System get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

Sonosite PX Ultrasound System

Q: What are the predicate devices for Sonosite PX Ultrasound System?

Sonosite PX Ultrasound System (K200964).

K213763 · FUJIFILM Sonosite, Inc. · IYN · Dec 27, 2021 · Radiology

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	AI/ML, Pediatric, 3rd-Party Reviewed

Intended 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)

Related Devices

K200964 — Sonosite PX Ultrasound System · FUJIFILM Sonosite, Inc. · May 8, 2020
K251830 — Sonosite LX Ultrasound System · FUJIFILM Sonosite, Inc. · Jul 10, 2025
K133134 — X-PORTE ULTRASOUND SYSTEM · FUJIFILM Sonosite, Inc. · Nov 4, 2013
K253448 — Sonosite MT Ultrasound System · FUJIFILM Sonosite, Inc. · Nov 3, 2025
K014116 — HAND-CARRIED ULTRASOUND SYSTEM · Sonosite,Inc. · Dec 20, 2001

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 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: Address: | FUJIFILM SonoSite, Inc. 21919 30th Drive SE 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 & 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 Accessories | | Regulation Name: | Ultrasonic Pulsed Doppler Imaging System Ultrasonic Pulsed Echo Imaging System Diagnostic Ultrasound Transducer | | Regulation Number: | 21 CFR 892.1550 21 CFR 892.1560 21 CFR 892.1570 | | Primary Product Code: | IYN | | Secondary Product Codes: | IYO ITX OIJ | | Device Class: | Class II | | Classification Panel: | Radiology | {4}------------------------------------------------ # 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 {5}------------------------------------------------ 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. {6}------------------------------------------------ # 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 System | Sonosite PX Ultrasound System | SonoSite Edge II Ultrasound System | Evaluation of Differences | |--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | (This submission) | (K200964) | (K162045) | | | Intended Use | Diagnostic ultrasound imaging or fluid flow analysis of the human body | Diagnostic ultrasound imaging or fluid flow analysis of the human body | Diagnostic ultrasound imaging or fluid flow analysis of the human body | The intended use of the Sonosite PX is identical to the predicate and reference devices. | | Indications for Use | Abdominal Adult Cephalic Cardiac Adult Cardiac Pediatric Fetal - OB/GYN Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Ophthalmic Pediatric Small Organ (breast, thyroid, testicle, prostate) Transvaginal Peripheral Vessel Trans-Rectal Trans-esophageal (cardiac) Needle guidance | Abdominal Adult Cephalic Cardiac Adult Cardiac Pediatric Fetal - OB/GYN Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Ophthalmic Pediatric Small Organ (breast, thyroid, testicle, prostate) Peripheral Vessel Transvaginal Needle guidance | Abdominal Adult Cephalic Cardiac Adult Cardiac Pediatric Fetal - OB/GYN Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Ophthalmic Pediatric Small Organ (breast, thyroid, testicle, prostate) Transvaginal Peripheral Vessel Needle guidance Neonatal Cephalic Trans-Rectal Trans-esophageal (cardiac) Needle guidance | The Indications for Use are a subset of Sonosite PX Ultrasound system (primary predicate- K200964) and Sonosite Edge II Ultrasound system (reference device- K162045). | | Transducer Types | Linear Array Curved Linear Array Phased Array Intracavitary Trans-esophageal | Linear Array Curved Linear Array Phased Array Intracavitary | Linear Array Curved Linear Array Phased Array Intracavitary Trans-esophageal | Transducer types for Sonosite PX are all a subset of Sonosite PX Ultrasound system (primary predicate) and Sonosite Edge II Ultrasound system (reference device). | | Transducer Frequency | 1.0-19.0 MHz | 1.0-19.0 MHz | 1.0 - 15.0 MHz | The frequency range for Sonosite PX is unchanged and the same as the primary predicate Sonosite PX (K200964) | | Global | Ispta.3: 607 mW/cm^2 | Ispta.3: 607 mW/cm^2 | Ispta.3: 598.9 | Acoustic output is | | Maximum Outputs/Worst Case Setting | (L12-3) TI Type: TIB (P5-1) TI Value: 4.87 (P5-1) MI: 1.72 (L12-3) Ipa.3@MI Max: 793 mW/cm^2 (L15-4) | (L12-3) TI Type: TIB (P5-1) TI Value: 4.87 (P5- 1) MI: 1.72 (L12-3) Ipa.3@MI Max: 793 mW/cm^2 (L15-4) | (HFL50x) TI Type: TIB (rP19x) TI Value: 4.98 (rP19x) MI: 1.7 (rP19x) Ipa.3@MI Max: 776 (L38xi) | less than FDA established limits. | | Acoustic Output Display & FDA Limits | Display Feature for Higher Outputs MI Output Display TI Output Display | Display Feature for Higher Outputs MI Output Display TI Output Display | Display Feature for Higher Outputs MI Output Display TI Output Display | MI & TI are always displayed and a power management system ensures that they never exceed the derated FDA limits. | | Modes of Operation | | | | | | | B-mode Grayscale Imaging | B-mode Grayscale Imaging | B-mode Grayscale Imaging | Modes of operation are a subset of Sonosite PX Ultrasound system (primary predicate) and Sonosite Edge II Ultrasound system (reference device). The AMM imaging frame and transmit sequence is identical to regular simultaneous 2D/M- mode as seen on predicate device Sonosite PX (K200964). The only difference is the AMM line is extracted from the 2D image data based on the AMM line position the user specified and the display in the sweep field of view. | | | Tissue Harmonic Imaging | Tissue Harmonic Imaging | Tissue Harmonic Imaging | | | | M-mode Simultaneous M- Mode AMM | M-mode Simultaneous M- Mode | M-mode Color M-Mode | | | | Color Power Doppler Zoom | Color Power Doppler Zoom | Color Power Doppler Zoom | | | | Combination Modes Pulsed Wave (PW) Doppler | Combination Modes Pulsed Wave (PW) Doppler | Combination Modes Pulsed Wave (PW) Doppler | | | | Continuous Wave (CW) Doppler | Continuous Wave (CW) Doppler | Continuous Wave (CW) Doppler | | | | Speckle reduction algorithm (formerly branded as SonoHD2 Noise Reduction) | Speckle reduction algorithm (formerly branded as SonoHD2 Noise Reduction) | SonoHD2 Noise Reduction | | | | SonoMB/MBe Image Compounding | SonoMB/MBe Image Compounding | SonoMB/MBe Image Compounding | | | | CW Doppler Velocity Color Doppler Tissue Doppler Imaging (TDI) | CW Doppler Velocity Color Doppler Tissue Doppler Imaging (TDI) | Steered CW Doppler Velocity Color Doppler Tissue Doppler Imaging (TDI) | | | DICOM | DICOM 3.0 Store and Offline Media | DICOM 3.0 Store, Print, Modality Worklist, Perform Procedure Step(PPS), Storage Commitment | DICOM 3.0 Store, Print, Modality Worklist, Perform ProcedureStep (PPS), Storage Commitment | Includes a subset of thisinformation | | #Transmit Channels | 128 digital channels | 128 digital channels | 128 digital channels | - | | #Receive Channels | 128 digital channels | 64 digital channels (128 digital channels usingSynthetic Aperture) | 64 digital channels (128 digital channels using Synthetic Aperture) | - | | Patient Contact Materials | Transducers: Silicone Rubber Polysulfone Poly Vinyl Chloride (PVC) Silicone RTV Adhesive Silicone Polymethyl-pentene Epoxy Paste Adhesive Polyurethane FKM rubber Thermoplastic polyurethane Needle Guides: Acetal copolymer Acrylonitrile- butadien- styrene (ABS) | Transducers: Silicone Rubber Polysulfon e UDEL P1700 Poly Vinyl Chloride (PVC)Silicone RTV Adhesive Silicone Needle Guides: Acetal copolymer Acrylonitrile-butadien-styrene (ABS) | Transducers: Acrylonitrile-butadien- styrene (ABS) Cycoloy Epoxy paste adhesive Polyethylene (PE) lonomer Polyetheretherketone (PEEK)Polycarbonate Polysulfone UDEL Polyurethane Poly Vinyl Chloride (PVC) Silicone RTV Adhesive Silicone Rubber Urethane Needle Guides: Acetal copolymer Acrylonitrile- butadien-styrene (ABS) | All patient contact materials have been testedto ISO 10993-1. Materials used in SonositePX have undergone identical biocompatibility and cleaning/disinfection testing to the predicate devices. Bio-compatibility summary test results are provided in D00414, Bio- compatibility Test Report, included in Attachment 6 ofthis submission. | | Product Safety Certification | AAMI/ANSI ES60601- 1:2005 (R2012) IEC 60601-2- 37:2007+AMD 1:2015 CAN/CSA-C22.2 No. 60601-1:14 JSA JIS T 0601-1:2017, JSA JIS T 0601-2-37 IEC 61157:2007+AMD1:2013 | AAMI/ANSI ES60601-1:2005 (R2012 IEC 60601-2- 37:2007+AMD 1:2015 CAN/CSA-C22.2 No. 60601-1:14 JSAJIS T 0601-1:2017, JSA JIS T 0601-2-37 IEC 61157:2007+AMD1:2013 | AAMI/ANSI ES60601- 1:2005 (R2012) IEC 60601-2-37: 2007 CAN/CSA C22.2 No. 60601- 1:08 NEMA UD2-2004 IEC 62359:2010 | | | | IEC 62359:2010+AMD1:2017 | NEMA UD 2-2004 (R2009) IEC 62359:2010+AMD1:2017 | | | | EMC Compliance | IEC 60601-1-2:2014 CISPR 11:2015+AMD1:2016 +AMD2:2019 IEC 61000-4-2. IEC 61000-4-3 IEC 61000-4-4. IEC 61000-4-5 IEC 61000-4-6. IEC 61000-4-8 IEC 61000-4-11 | IEC 60601-1-2:2014 CISPR 11:2015+AMD1:2016 +AMD2 IEC 61000-4-2. IEC 61000-4-3 IEC 61000-4-4. IEC 61000-4-5 IEC 61000-4-6. IEC 61000-4-8 IEC 61000-4-11 | AAMI / ANSI / IEC 60601-1- 2:2007(R)2012 CISPR 11, Group 1, Class A | | | DICOM | DICOM PS3.15 2011 | NEMA PS3.15 2003 | NEMA PS3.15 2003 | | | Airborne Equipment Standards | none applied | none applied | RTCA/DO160 (section 21) | Airborne equipment standards have not been applied to the Sonosite PXultrasound system and labeling will not claim to this. | | System | Sonosite PX: | Sonosite PX: | Edge II: | Sonosite PX 2.0 | | Characteristics | Beamformer 128/128 using SA (configurable) 12.1" Capacitive touch screen interface 19" LED LCD HD monitor 256 gray shades on LED LCD | Beamformer 128/128 using SA (configurable) 12.1" Capacitive touch screen interface 19" LED LCD HD monitor 256 gray shades on LED LCD | Beamformer 128/128 using SA (configurable) Hand held display and control Single 12.1" Liquid Crystal Display (LCD) 256 gray shades on LCD2 | includes a non- diagnostic ECG module.Like reference device Edge II ultrasound system (K162045), this module provides ECG tracing of the | | | 2 USB 3.0 4 USB 2.0 | 2 USB 3.0 4 USB 2.0 | USB ports | cardiac signal synchronized with the ultrasound | | | Stand Base Dimensions: 26.4" L x 21.2" W Stand Height (max): 64" (monitor up) Stand Height (min): 42.2" (monitor down) Weight: 149.35 lbs (fully configured w/ 3 transducers and stand base Weight: 32.80 lbs (w/ 1 transducer) | Stand Base Dimensions: 26.4" L x 21.2" W Stand Height (max): 64" (monitor up) Stand Height (min): 42.2" (monitor down) Weight: 149.35 lbs (fully configured w/ 3 transducers and stand base Weight: 32.80 lbs (w/1 transducer) | Dimensions: 12.8"(W) x 12.1" (L) x 2.5"(H) Weight: 9.0 lbs | image. | | | System operates via battery or AC power | System operates via battery or AC power | System operates via battery or AC power | | | | Battery life: 1 hour imaging - 10 days idle | Battery life: 1 hour imaging - 10 days idle | Battery life: 1.5 - 4 hour operation per charge | | | | Input: 100 - 240 VAC, 50/60 Hz Output 1: 26.7VDC output, 220 W max System on stand: | Input: 100 - 240 VAC, 50/60 Hz Output 1: 26.7VDC output, 220 W max System on stand: | 100 - 240V options, 50/60Hz, 15VDC output | | | | Input: 100 - 240 VAC, 50/60 Hz Output 1: 26.7VDC output, 220 W max Output 2: 100-240VAC, 50-60 Hz (AC Printer) | Input: 100 - 240 VAC, 50/60 Hz Output 1: 26.7VDC output, 220 W max Output 2: 100-240VAC, 50-60 Hz (AC Printer) | | | | | Various obstetrical, cardiac, volume, M-mode,PW and CW Doppler measurement and calculation packages | Various obstetrical, cardiac, volume, M-mode, PW and CW Doppler measurement and calculation packages | Various obstetrical, cardiac, volume, M- mode, PW and CW Doppler measurement and calculation packages | | | | Non-diagnostic ECG tracing | | Non-diagnostic ECG tracing, CW/PW Doppler Audio Spectral Doppler Audio and image storage on removable media | | | | Wireless 802.11 (a/b/g/n) | Wireless 802.11 (a/b/g/n) support for image transfer | Wireless 802.11 (b/g/n) support for image transfer | | | | Additional system features: Assisted CardiacOutput (ACO) - Available on Sonosite PX system | Additional system features: Assisted Cardiac Output (ACO) - Available on Sonosite PX system…