The SonoSite iViz Ultrasound System is a general purpose ultrasound system and non-continuous patient monitoring platform intended for use in clinical care by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis. Specific clinical applications and exam types include:

Fetal - OB/GYN Abdominal Pediatric Small Organ (breast, thyroid, testicles, prostate) Musculo-skel. (Convent.) Musculo-skel. (Superfic.) Cardiac Adult Cardiac Pediatric Peripheral vessel Ophthalmic

Device Description

The SonoSite iViz Ultrasound System is a highly featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. iViz is a custom fabricated digital electronic handheld tablet that is highly portable, battery-operated, and consists of an active transducer that connects to and is controlled by the tablet. iViz supports Bluetooth and wireless network connectivity for image transfer and over-the-air (OTA) software updates.

AI/ML Overview

The provided document is a 510(k) premarket notification for the FUJIFILM SonoSite iViz Ultrasound System. The purpose of this document is to demonstrate that the iViz Ultrasound System is substantially equivalent to legally marketed predicate devices.

Here's an analysis of the acceptance criteria and the study information as requested:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria in terms of specific performance metrics (e.g., accuracy, sensitivity, specificity, image quality scores) for the device's diagnostic capabilities. Instead, the "acceptance criteria" are implied through the comparisons to predicate devices and adherence to recognized standards.

The primary method to demonstrate acceptance is through substantial equivalence to existing, legally marketed predicate devices by showing comparable:

Intended Use
Indications for Use
Technological Characteristics
Safety and Effectiveness (via non-clinical testing)

Below is a table summarizing the general "acceptance criteria" (implicitly by comparison to predicates and standards) and the device's reported performance (by asserting compliance and equivalence).

Acceptance Criteria (Implicit)	Reported Device Performance
Intended Use Equivalence: Device intended for diagnostic ultrasound imaging or fluid flow analysis of the human body, comparable to predicate devices.	The SonoSite iViz Ultrasound System has the same intended use as the predicate devices: "a general purpose ultrasound system and non-continuous patient monitoring platform intended for use in clinical care by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis."
Indications for Use Equivalence: Device supported clinical applications align with or expand upon those of predicate devices.	The SonoSite iViz Ultrasound System and its various transducers (L38v/10-5 MHz, P21v/5-1 MHz, C60v/5-2 MHz, L25v/13-6 MHz) cover a range of clinical applications including Fetal, Abdominal, Pediatric, Small Organ, Musculo-skeletal, Cardiac Adult/Pediatric, Peripheral vessel, and Ophthalmic. Many of these are "P" (previously cleared) from identified predicate devices (K162288, K133454, K162045, K152983), and some are "N" (new indications) for specific transducers. The document asserts these are consistent with predicates.
Technological Characteristics Equivalence: Fundamental scientific technology, transducer types, frequency ranges, and modes of operation are comparable to predicate devices.	The SonoSite iViz Ultrasound System employs the "same fundamental scientific technology" as the SonoSite iViz, Edge, and Edge II Ultrasound systems (Track 3 devices). Comparison tables (Pg 9) detail comparable transducer types (Linear Array, Phased Array, Curved Array), frequency ranges (1.0 - 13.0 MHz), and modes of operation (B-mode, M-mode, Color Power Doppler, SonoHD3 Noise Reduction, etc.), with some differences noted (e.g., PW and CW Doppler not available on iViz but available on older Edge models).
Safety and Effectiveness: Compliance with recognized electrical, thermal, mechanical, EMC, cleaning/disinfection, biocompatibility, and acoustic output standards.	The iViz Ultrasound System was evaluated for electrical, thermal, mechanical, and EMC safety, cleaning/disinfection, biocompatibility, and acoustic output. It was found to conform to applicable mandatory medical device safety standards (e.g., ISO 10993-1, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-37, IEC 62304, IEC 62359, ISO 14971, NEMA UD 2-2004). Quality assurance processes were also followed.
No new questions of safety or effectiveness are raised.	The conclusion explicitly states that "FUJIFILM SonoSite, Inc. believes that the iViz Ultrasound System is substantially equivalent with regard to safety and effectiveness to the predicate devices."

Study Proving Acceptance Criteria:

The document states: "The iViz Ultrasound System and transducers, subject of this submission, did not require clinical studies to support the determination of substantial equivalence."

Instead, the determination of substantial equivalence is based on non-clinical tests and a comparison of technological characteristics and intended uses with identified predicate devices.

2. Sample Size Used for the Test Set and Data Provenance:

No clinical test set was used, as no clinical studies were deemed necessary. The acceptance was based on non-clinical testing and comparison to predicates.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable, as no clinical test set requiring expert ground truth was utilized.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set requiring adjudication was utilized.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool for interpretation by human readers. The document makes no mention of AI assistance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. The device is a diagnostic ultrasound system, operated by a qualified physician or healthcare professional. It is not a standalone algorithm.

7. The Type of Ground Truth Used:

For the non-clinical tests (e.g., electrical, thermal, EMC, acoustic output), the "ground truth" would be the specifications and requirements defined by the referenced industry standards (e.g., IEC 60601 series, ISO 10993, NEMA UD 2-2004). The device's performance against these standards served as the "ground truth" for non-clinical acceptance.

8. The Sample Size for the Training Set:

Not applicable. The document does not describe the development of an AI model or algorithm that would require a "training set."

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there was no mention of a training set for an AI model.

Summary

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April 13, 2018

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 seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below it. The logo is simple and professional, and it is easily recognizable.

FUJIFILM SonoSite, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street. NW BUFFALO MN 55313

Re: K180704

Trade/Device Name: SonoSite iViz Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: March 15, 2018 Received: March 19, 2018

Dear Mr. Job:

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.

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn

(http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D. O'Hara For

Robert Ochs, Ph.D. 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

510(k) Number (if known) K180704

Device Name SonoSite iViz Ultrasound System

Indications for Use (Describe)

Fetal - OB/GYN Abdominal Pediatric Small Organ (breast, thyroid, testicles, prostate) Musculo-skel. (Convent.) Musculo-skel. (Superfic.) Cardiac Adult Cardiac Pediatric Peripheral vessel Ophthalmic

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)
-------------------------------------------------------------------------------------------------------------------------------------------------------	------------------------------------------------------------------------------------------------------------------------------------------------------

Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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Table 1.3-1: Diagnostic Ultrasound Indications for Use Form – FUJIFILM SonoSite iViz Ultrasound System

System:	FUJIFILM SonoSite iViz Ultrasound System
Transducer:	N/A
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human
	body as follows:
Clinical Application	Mode of Operation
	B	M	PWD	CWD	ColorDoppler	Combined(Spec.)	Other(Spec.)
Ophthalmic	N	N			N	B+M; B+CD	1,3
Fetal	P	P			P	B+M; B+CD	1-3
Abdominal	P	P			P	B+M; B+CD	1-3
Intra-operative (Abdominalorgans and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P			P	B+M; B+CD	1-3
Small Organ (breast, thyroid,testicles, prostate)	P	P			P	B+M; B+CD	1,3
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)	P	P			P	B+M; B+CD	1,3
Musculo-skel. (Superfic.)	P	P			P	B+M; B+CD	1,3
Intra-luminal
Other (spec.)
Cardiac Adult	P	P			P	B+M; B+CD	1-3
Cardiac Pediatric	P	P			P	B+M; B+CD	1-3
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	P	P			P	B+M; B+CD	1,3
Other (spec.)

N= new indication; P= previously cleared by FDA; E= added under this appendix

Additional Comments:

1: Color Doppler includes Power/Velocity/Variance

2: Tissue Harmonic Imaging (THI)

3: SonoHD3 Imaging (Speckle Reduction)

All items marked "P" were previously cleared in 510(k) K162288.

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Table 1.3-2: Diagnostic Ultrasound Indications for Use Form – L38v/10-5 MHz Transducer

System:	FUJIFILM SonoSite iViz Ultrasound System
Transducer:	L38v/10-5 MHz Transducer
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the humanbody as follows:
Clinical Application	Mode of Operation
	B	M	PWD	CWD	ColorDoppler	Combined(Spec.)	Other(Spec.)
Ophthalmic	N	N			N		1,3
Fetal
Abdominal	P	P			P	B+M; B+CD	1,3
Intra-operative (Abdominalorgans and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P			P	B+M; B+CD	1,3
Small Organ (breast, thyroid,testicles, prostate)	P	P			P	B+M; B+CD	1,3
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)	P	P			P	B+M; B+CD	1,3
Musculo-skel. (Superfic.)	P	P			P	B+M; B+CD	1,3
Intra-luminal
Other (spec.)
Cardiac Adult	N	N			N	B+M; B+CD	1-3
Cardiac Pediatric	N	N			N	B+M; B+CD	1-3
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	P	P			P	B+M; B+CD	1,3
Other (spec.)

N= new indication; P= previously cleared by FDA; E= added under this appendix

Additional Comments:

1: Color Doppler includes Power/Velocity/Variance

2: Tissue Harmonic Imaging (THI)

3: SonoHD3 Imaging (Speckle Reduction)

All items marked "P" were previously cleared in 510(k) K162288, K133454 and K162045.

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Table 1.3-3: Diagnostic Ultrasound Indications for Use Form – P21v/5-1 MHz Transducer

System:	FUJIFILM SonoSite iViz Ultrasound System
Transducer:	P21v/5-1 MHz Transducer
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application	Mode of Operation
	B	M	PWD	CWD	Color Doppler	Combined (Spec.)	Other (Spec.)
Ophthalmic
Fetal	P	P			P	B+M; B+CD	1-3
Abdominal	P	P			P	B+M; B+CD	1-3
Intra-operative (Abdominal organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P			P	B+M; B+CD	1-3
Small Organ (breast, thyroid, testicles, prostate)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Intra-luminal
Other (spec.)
Cardiac Adult	P	P			P	B+M; B+CD	1-3
Cardiac Pediatric	P	P			P	B+M; B+CD	1-3
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel
Other (spec.)

N= new indication; P= previously cleared by FDA; E= added under this appendix

Additional Comments:

1: Color Doppler includes Power/Velocity/Variance

2: Tissue Harmonic Imaging (THI)

3: SonoHD3 Imaging (Speckle Reduction)

All items marked "P" were previously cleared in 510(k) K152983.

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Table 1.3-4: Diagnostic Ultrasound Indications for Use Form – C60v/5-2 MHz Transducer

System:	FUJIFILM SonoSite iViz Ultrasound System
Transducer:	C60v/5-2 MHz Transducer
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human
	body as follows:
Clinical Application	Mode of Operation
	B	M	PWD	CWD	Color Doppler	Combined (Spec.)	Other (Spec.)
Ophthalmic
Fetal	N	N			N	B+M; B+CD	1-3
Abdominal	N	N			N	B+M; B+CD	1-3
Intra-operative (Abdominalorgans and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	N	N			N	B+M; B+CD	1-3
Small Organ (breast, thyroid,testicles, prostate)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)	N	N			N	B+M; B+CD	1-3
Musculo-skel. (Superfic.)	N	N			N	B+M; B+CD	1-3
Intra-luminal
Other (spec.)
Cardiac Adult
Cardiac Pediatric
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel
Other (spec.)

N= new indication; P= previously cleared by FDA; E= added under this appendix

Additional Comments:

1: Color Doppler includes Power/Velocity/Variance

2: Tissue Harmonic Imaging (THI)
3: SonoHD3 Imaging (Speckle Reduction)

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Table 1.3-5: Diagnostic Ultrasound Indications for Use Form – L25v/13-6 MHz Transducer

System:	FUJIFILM SonoSite iViz Ultrasound System
Transducer:	L25v/13-6 MHz Transducer
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the humanbody as follows:
Clinical Application	Mode of Operation
	B	M	PWD	CWD	Color Doppler	Combined (Spec.)	Other (Spec.)
Ophthalmic	N	N			N	B+M; B+CD	1,3
Fetal
Abdominal
Intra-operative (Abdominal organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric
Small Organ (breast, thyroid, testicles, prostate)	N	N			N	B+M; B+CD	1,3
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)	N	N			N	B+M; B+CD	1,3
Musculo-skel. (Superfic.)	N	N			N	B+M; B+CD	1,3
Intra-luminal
Other (spec.)
Cardiac Adult	N	N			N	B+M; B+CD	1-3
Cardiac Pediatric	N	N			N	B+M; B+CD	1-3
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	N	N			N	B+M; B+CD	1,3
Other (spec.)

N= new indication; P= previously cleared by FDA; E= added under this appendix

Additional Comments:

1: Color Doppler includes Power/Velocity/Variance

2: Tissue Harmonic Imaging (THI)

3: SonoHD3 Imaging (Speckle Reduction)

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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's name, address, telephone number, contact person:

FUJIFILM SonoSite, Inc. 21919 30th Drive SE Bothell, WA 98021-3904

Corresponding Official:	Sudipta Chakrabarti
	Sr. Regulatory Affairs Specialist
E-mail:	sudipta.chakrabarti@fujifilm.com
Telephone:	(425) 951-1371
Facsimile:	(425) 951-1201
Date prepared:	February 12, 2018

2) Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known:

Common/ Usual Name

Diagnostic Ultrasound System with Accessories

Proprietary Name

SonoSite iViz Ultrasound System

Classification Names

Name	FR Number	Product Code
Ultrasonic Pulsed Doppler Imaging System	892.1550	90-IYN
Ultrasonic Pulsed Echo Imaging System	892.1560	90-IYO
Diagnostic Ultrasound Transducer	892.1570	90-ITX

3) Identification of the predicate or legally marketed device:

Primary Predicates

SonoSite iViz Ultrasound System	K162288
SonoSite Edge Ultrasound System	K133454
SonoSite Edge II Ultrasound System	K162045

Reference Predicates

L25x/13-6 MHz Transducer, previously cleared in the primary predicate Edge II 510(k) submission (K162045)

C60x/5-2 MHz transducer, previously cleared in the primary predicate Edge 510(k) submission (K133454) L38v/10-5 MHz transducer, previously cleared in the primary predicate iViz 510(k) submission (K162288)

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4) Device Description:

5) Intended Use:

Fetal OB/GYN Abdominal Pediatric Small Organ (breast, thyroid, testicles, prostate) Musculo-skel. (Convent.) Musculo-skel. (Superfic.) Cardiac Adult Cardiac Pediatric Peripheral vessel Ophthalmic

6) Technological Characteristics:

SonoSite iViz and Edge Ultrasound Systems are Track 3 devices that employ the same fundamental scientific technology. A comparison table is provided below.

Feature	SonoSite iVizUltrasoundSystem(This submission)	SonoSite iVizUltrasound System(K162288)	SonoSite EdgeUltrasound System(K133454)	SonoSite Edge IIUltrasound System(K162045)
Intended Use	Diagnosticultrasound imagingor fluid flow analysisof the human body	Diagnostic ultrasoundimaging or fluid flowanalysis of the humanbody	Diagnostic ultrasoundimaging or fluid flowanalysis of the humanbody	Diagnostic ultrasoundimaging or fluid flowanalysis of the humanbody
Indications forUse	Fetal - OB/GYNAbdominalPediatricSmall Organ(breast, thyroid,testicle, prostate)Musculo-skeletal(Conventional)Musculo-skeletal(Superficial)Cardiac AdultCardiac PediatricPeripheral VesselOphthalmic	Fetal - OBAbdominalPediatricSmall Organ (breast,thyroid, testicle, prostate)Musculo-skeletal(Conventional)Musculo-skeletal(Superficial)Cardiac AdultCardiac PediatricPeripheral Vessel	OphthalmicFetal - OB/GYNAbdominalIntraoperative (abdominalorgans and vascular)Intra-operative (Neuro.)PediatricSmall Organ (breast,thyroid, testicle, prostate)Neonatal CephalicAdult CephalicTrans-RectalTrans-VaginalMusculo-skeletal(Conventional)Musculo-skeletal(Superficial)Cardiac AdultCardiac PediatricTrans-esophageal	OphthalmicFetal - OB/GYNAbdominalPediatricSmall Organ (breast,thyroid, testicle, prostate)Neonatal CephalicAdult CephalicTrans-RectalTrans-VaginalMusculo-skeletal(Conventional)Musculo-skeletal(Superficial)
Feature	SonoSite iVizUltrasoundSystem(This submission)	SonoSite iVizUltrasound System(K162288)	SonoSite EdgeUltrasound System(K133454)	SonoSite Edge IIUltrasound System(K162045)
			(cardiac)Peripheral VesselNeedle guidance	Cardiac AdultCardiac PediatricTrans-esophageal(cardiac)Peripheral VesselNeedle guidance
TransducerTypes	Linear ArrayPhased ArrayCurved Array	Linear ArrayPhased Array	Linear ArrayCurved Linear ArrayIntracavitaryPhased ArrayStatic ProbesTrans-esophageal	Linear ArrayCurved Linear ArrayIntracavitaryPhased ArrayTrans-esophageal
TransducerFrequency	1.0 - 13.0 MHz	1.0 - 10.0 MHz	1.0 - 15.0 MHz	1.0 - 15.0 MHz
Modes ofOperation	B-mode GrayscaleImagingTissue HarmonicImagingM-modeColor M-ModeColor PowerDopplerZoomCombination ModesSonoHD3 NoiseReductionVelocity ColorDoppler	B-mode GrayscaleImagingTissue Harmonic ImagingM-modeColor M-ModeColor Power DopplerZoomCombination ModesSonoHD3 NoiseReductionVelocity Color Doppler	B-mode Grayscale ImagingTissue Harmonic ImagingM-modeColor M-ModeColor Power DopplerZoomCombination ModesPulsed Wave (PW)DopplerContinuous Wave (CW)DopplerSonoHD2 Noise ReductionSonoMB/MBe ImageCompoundingSteered CW DopplerVelocity Color DopplerTissue Doppler Imaging(TDI)	B-mode GrayscaleImagingTissue Harmonic ImagingM-modeColor M-ModeColor Power DopplerZoomCombination ModesPulsed Wave (PW)DopplerContinuous Wave (CW)DopplerSonoHD2 NoiseReductionSonoMB/MBe ImageCompoundingSteered CW DopplerVelocity Color DopplerTissue Doppler Imaging(TDI)
PW Doppler	Not available	Not available	Available	Available
CW Doppler	Not available	Not available	Available	Available
Patient ContactMaterials	Transducers:Polysulfone UDELP1700Poly-Vinyl-Chloride(PVC)Silicone Rubber	Transducers:Polysulfone UDEL P1700Poly-Vinyl-Chloride (PVC)Silicone Rubber	Transducers:Acrylonitrile-butadien-styrene (ABS)CycoloyDow Medical Adhesive,Type AEpoxy paste adhesivePolyethylene (PE) IonomerPolyetheretherketone(PEEK)Polysulfone UDEL P1700PolyurethanePoly-Vinyl-Chloride (PVC)Silicone RTV AdhesiveSilicone RubberUrethaneNeedle Guides:Acetal copolymerAcrylonitrile-butadien-styrene (ABS)	Transducers:Acrylonitrile-butadien-styrene (ABS)CycoloyEpoxy paste adhesivePolyethylene (PE)lonomerPolyetheretherketone(PEEK)PolycarbonatePolysulfone UDEL P1700PolyurethanePoly-Vinyl-Chloride (PVC)Silicone RTV AdhesiveSilicone Rubber
Feature	SonoSite iVizUltrasoundSystem(This submission)	SonoSite iVizUltrasound System(K162288)	SonoSite EdgeUltrasound System(K133454)	SonoSite Edge IIUltrasound System(K162045)
SystemCharacteristics	iViz:Handheld tablet7", 1920 x 1200pixels LCDOperating system:AndroidiViz ultrasoundsoftware running asan "app" on tabletSystem operatesvia batteryWireless 802.11support for imagetransfer and over-the-air (OTA)software updates	iViz:Handheld tablet7", 1920 x 1200 pixelsLCDOperating system: AndroidiViz ultrasound softwarerunning as an "app" ontabletSystem operates viabatteryWireless 802.11 supportfor image transfer andover-the-air (OTA)software updates	Edge:Handheld display andcontrol12.1", 800 x 600 pixels,LCDOperating system:Windows CESystem operates viabattery or AC powerWireless 802.11 supportfor image transfer	UrethaneNeedle Guides:Acetal copolymerAcrylonitrile-butadien-styrene (ABS)Edge II:Beamformer 128/128using SA (configurable)Hand held display andcontrolSingle 12.1" Liquid CrystalDisplay (LCD)256 gray shades on LCD2 USB portsDimensions: 12.8"(W) x12.1" (L) x 2.5"(H)Weight: 9.0 lbsSystem operates viabattery or AC powerBattery life: 1.5 - 4 houroperation per charge100 - 240V options, 50/60Hz, 15VDC outputVarious obstetrical,cardiac, volume, M-mode,PW and CW Dopplermeasurement andcalculation packagesECG acquisition anddisplay capabilitiesCW/PW Doppler AudioSpectral Doppler Audioand image storage onremovable media
Feature	SonoSite iVizUltrasoundSystem(This submission)	SonoSite iVizUltrasound System(K162288)	SonoSite EdgeUltrasound System(K133454)	SonoSite Edge IIUltrasound System(K162045)
				Wireless 802.11 (b/g/n)support for image transfer
510(k) Track	Track 3	Track 3	Track 3	Track 3

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7) Determination of Substantial Equivalence:

Summary of Non-Clinical Tests:

The iViz Ultrasound System has been evaluated for electrical, thermal, mechanical, and EMC safety. Additionally, cleaning/disinfection, biocompatibility, and acoustic output have been evaluated, and the device has been found to conform to applicable mandatory medical device safety standards. Assurance of quality was established by employing the following elements of product development but were not limited to: Design Phase Reviews, Risk Assessment, Requirements Development, and Verification and Validation.

The iViz Ultrasound System is designed to comply with the following FDA recognized standards.

Reference No.	Title
ISO 10993-1	AAMI / ANSI / ISO 10993-1:2009/(R)2013, Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process
IEC 60601-1	AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012,, C1:2009/(R)2012 andA2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: Generalrequirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
IEC 60601-1-2	AAMI / ANSI / IEC 60601-1-2:2007(R)2012, Medical electrical equipment - Part 1-2:General requirements for basic safety and essential performance - Collateralstandard: Electromagnetic compatibility - Requirements and tests (Edition 3)
IEC 60601-1-6	IEC 60601-1-6 Edition 3.1 2013-10, Medical electrical equipment - Part 1-6: Generalrequirements for basic safety and essential performance - Collateral standard:Usability
IEC 60601-2-37	IEC 60601-2-37:2007 Edition 2.0 2007-08, Medical electrical equipment – Part 2-37:Particular requirements for the basic safety and essential performance of ultrasonicmedical diagnostic and monitoring equipment
IEC 62304	AAMI / ANSI / IEC 62304:2006, Medical device software - Software life cycleprocesses
IEC 62359	IEC 62359 Edition 2.0 2010-10-10, Ultrasonics - Field characterization - Testmethods for the determination of thermal and mechanical indices related to medicaldiagnostic ultrasonic fields [Including: Technical corrigendum 1 (2011)]
ISO 14971	ISO 14971:2007, Medical devices - Application of risk management to medicaldevices
NEMA UD 2-2004	Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment

Summary of Clinical Tests:

The iViz Ultrasound System and transducers, subject of this submission, did not require clinical studies to support the determination of substantial equivalence.

8) Conclusion:

Intended uses and other key features are consistent with traditional clinical practice and FDA guidance. The iViz system and predicates meet FDA requirements for Track 3 devices, share indications for use, have biosafety equivalence, and conform to applicable electromedical device safety standards. FUJIFILM SonoSite, Inc. believes that the iViz Ultrasound System is substantially equivalent with regard to safety and effectiveness to the predicate devices.

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
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.(b)
Classification. Class II.