The SonoSite Edge II 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: Ophthalmic Fetal - OB/GYN Abdominal Pediatric Small Organ (breast, thyroid, testicle, prostate) Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Cardiac Adult Cardiac Pediatric Trans-esophageal (cardiac) Peripheral Vessel

The SonoSite SII 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: Ophthalmic Fetal - OB/GYN Abdominal Pediatric Small Organ (breast, thyroid, testicle, prostate) Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Cardiac Adult Cardiac Pediatric Peripheral Vessel

Device Description

SONOSITE EDGE II ULTRASOUND SYSTEM: The SonoSite Edge II Ultrasound System is a portable laptop style, full featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. Edge II is a custom fabricated digital electronic design that readily lends itself to be configured for specific ultrasound imaging applications through different system feature selections. Edge II can operate on either battery or AC power.

SONOSITE SII ULTRASOUND SYSTEM The SonoSite SII Ultrasound System is a mountable style, full featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. SII is a custom fabricated digital electronic design that readily lends itself to be configured for specific ultrasound imaging applications through different system feature selections. SII can operate on either battery or AC power.

AI/ML Overview

The provided text is a 510(k) Premarket Notification summary for the FUJIFILM SonoSite Edge II and SonoSite SII Ultrasound Systems. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving performance against specific acceptance criteria for a novel AI/ML algorithm.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving a device meets these criteria for an AI/ML algorithm. The document discusses:

Indications for Use: The clinical applications for which the ultrasound systems are intended.
Technological Characteristics: A comparison of the subject devices (SonoSite Edge II and SII) with their predicate devices (various SonoSite Edge and FC1 models), highlighting similarities in intended use, transducer types, frequency ranges, maximum acoustic outputs, modes of operation (e.g., B-mode, M-mode, Color Doppler), ECG features, DICOM compatibility, and various safety and electromagnetic compatibility standards.
Non-Clinical Tests Summary: Mention of electrical, thermal, mechanical, EMC safety, cleaning/disinfection, biocompatibility, and acoustic output evaluations, and conformity to applicable mandatory medical device safety standards.
Clinical Tests Summary: Explicitly states that clinical studies were not required to support the determination of substantial equivalence.

Since this document describes an ultrasound system (a hardware device) and its transducers, and not an AI/ML algorithm, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI/ML performance (e.g., sensitivity, specificity, AUC) are not addressed. The "acceptance criteria" here are implicitly about demonstrating equivalence to existing, cleared ultrasound systems based on technological characteristics and non-clinical safety/performance data.

Specifically, the requested information cannot be extracted from the provided text because:

A table of acceptance criteria and the reported device performance: Not provided in the context of AI/ML performance. The tables list device features and intended uses, comparing them to predicates.
Sample size used for the test set and the data provenance: No test set or data provenance for AI/ML performance is mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no AI/ML performance ground truth is established.
Adjudication method: Not applicable.
MRMC comparative effectiveness study: Not conducted or mentioned for AI/ML assistance.
Standalone (i.e. algorithm only without human-in-the-loop performance) study: Not applicable, as this is a hardware ultrasound system.
The type of ground truth used: Not applicable for AI/ML. The provided information relates to the regulatory approval of a medical device (ultrasound system) based on substantial equivalence to predicates.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 18, 2016

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

Re: K162045

Trade/Device Name: SonoSite SII Ultrasound System and SonoSite Edge II Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: July 21, 2016 Received: July 25, 2016

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael D.'Hara

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health For

Enclosure

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Indications for Use

510(k) Number (if known) K162045

Device Name SonoSite Edge II Ultrasound System

Indications for Use (Describe)

Ophthalmic Fetal - OB/GYN Abdominal Pediatric Small Organ (breast, thyroid, testicle, prostate) Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Cardiac Adult Cardiac Pediatric Trans-esophageal (cardiac) Peripheral Vessel

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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SonoSite Edge II Ultrasound System:

The following are the Indications for Use for the SonoSite Edge II Ultrasound System

Table 1.3-1: Diagnostic Ultrasound Indications for Use Form - FUJIFILM SonoSite Edge II Ultrasound System

System:	FUJIFILM SonoSite Edge II Ultrasound System
Transducer:	N/A
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human bodyas follows:
Clinical Application	Mode of Operation
	B	M	PWD	CWD	ColorDoppler	Combined(Spec.)	Other(Spec.)
Ophthalmic	P	P	P		P	B+M; B+PWD; B+CD	1-5
Fetal	P	P	P		P	B+M; B+PWD; B+CD	1-5
Abdominal	P	P	P		P	B+M; B+PWD; B+CD	1-5
Intra-operative (Abdominalorgans and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P	P		P	B+M; B+PWD; B+CD	1-5
Small Organ (breast, thyroid,testicles, prostate)	P	P	P		P	B+M; B+PWD; B+CD	1-5
Neonatal Cephalic	P	P	P		P	B+M; B+PWD; B+CD	1-3,5
Adult Cephalic	P	P	P		P	B+M; B+PWD; B+CD	1-3,5
Trans-rectal	N	N	N		N	B+M; B+PWD; B+CD	1,5
Trans-vaginal	P	P	P		P	B+M; B+PWD; B+CD	1,5
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)	P	P	P		P	B+M; B+PWD; B+CD	1,2,4,5
Musculo-skel. (Superfic.)	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Intra-luminal
Other (spec.)
Cardiac Adult	P	P	P	P	P	B+M; B+PWD; B+CWD; B+CD	1-5
Cardiac Pediatric	P	P	P	P	P	B+M; B+PWD; B+CWD; B+CD	1-5
Trans-esophageal (card.)	P	P	P	P	P	B+M; B+PWD; B+CWD; B+CD	1,3
Other (spec.)
Peripheral vessel	P	P	P		P	B+M; B+PWD; B+CD	1-5
Other (spec.)

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

Additional Comments:

1: Includes imaging to assistin the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for peripheral nerve block procedures . Color Doppler includes Power/Velocity/Variance. M-Mode includes color M-Mode.

2: Tissue Harmonic Imaging (THI)

3: Tissue Doppler Imaging (TDI)

4: Steep Needle Profiling (Sono MBe)

5: Multi-beam Imaging (SonoMB) in B-Mode

All items marked "P" were previously cleared in 510(k) K153626 (Edge II).

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System:	FUJIFILM SonoSite Edge II Ultrasound System
Transducer:	C8x/8-5 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
Fetal
Abdominal
Intra-operative (Abdominalorgans and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric
Small Organ (breast, thyroid,testicles, prostate)
Neonatal Cephalic
Adult Cephalic
Trans-rectal	P	P	P		P	B+M; B+PWD; B+CD	1,5
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Intra-luminal
Other (spec.)
Cardiac Adult
Cardiac Pediatric
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel
Other (spec.)

Table 1.3-2: Diagnostic Ultrasound Indications for Use Form – C8x8-5 MHz Transducer

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

Additional Comments:

1: Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for peripheral nerve block procedures. Color Doppler includes Power/Velocity/Variance. M-Mode includes color M-Mode.

2: Tissue Harmonic Imaging (THI)

3: Tissue Doppler Imaging (TDI)

4: Steep Needle Profiling (Sono MBe)

5: Multi-beam Imaging (SonoMB) in B-Mode

All items marked "P" were previously cleared in 510(k) K133454 (Edge).

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System:	FUJIFILM SonoSite Edge II Ultrasound System
Transducer:	C11x/8-5 MHz Transducer
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the humanbody as follows:
Clinical Application	B	M	PWD	CWD	ColorDoppler	Combined(Spec.)	Other(Spec.)
Ophthalmic
Fetal
Abdominal	P	P	P		P	B+M; B+PWD; B+CD	1,5
Intra-operative (Abdominalorgans and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P	P		P	B+M; B+PWD; B+CD	1,5
Small Organ (breast, thyroid,testicles. prostate)
Neonatal Cephalic	P	P	P		P	B+M; B+PWD; B+CD	1,5
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Intra-luminal
Other (spec.)
Cardiac Adult
Cardiac Pediatric	P	P	P		P	B+M; B+PWD; B+CD	1,5
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	P	P	P		P	B+M; B+PWD; B+CD	1,5
Other (spec.)

Table 1.3-3: Diagnostic Ultrasound Indications for Use Form – C11x/8-5 Transducer

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

Additional Comments:

1: Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for peripheral nerve block procedures. Color Doppler includes Power/Velocity/Variance. M-Mode includes color M-Mode.

2: Tissue Harmonic Imaging (THI)

3: Tissue Doppler Imaging (TDI)

4: Steep Needle Profiling (Sono MBe)

5: Multi-beam Imaging (SonoMB) in B-Mode

All items marked "P" were previously cleared in 510(k) K153626 (Edge II).

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Table 1.3-4: Diagnostic Ultrasound Indications for Use Form – C35x/8-3 MHz Transducer

System:	FUJIFILM SonoSite Edge II Ultrasound System
Transducer:	C35x/8-3 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
Fetal	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Abdominal	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Intra-operative (Abdominalorgans and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Small Organ (breast, thyroid,testicles, prostate)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Musculo-skel. (Superfic.)	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Intra-luminal
Other (spec.)
Cardiac Adult
Cardiac Pediatric
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Other (spec.)

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

Additional Comments:

2: Tissue Harmonic Imaging (THI)

3: Tissue Doppler Imaging (TDI)

4: Steep Needle Profiling (Sono MBe)

5: Multi-beam Imaging (SonoMB) in B-Mode

All items marked "P" were previously cleared in 510(k) K160406 (FC1).

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System:	FUJIFILM SonoSite Edge II Ultrasound System
Transducer:	rC60xi/5-2 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
Fetal	P	P	P		P	B+M; B+PWD; B+CD	1,2,4,5
Abdominal	P	P	P		P	B+M; B+PWD; B+CD	1,2,4,5
Intra-operative (Abdominalorgans and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P	P		P	B+M; B+PWD; B+CD	1,2,4,5
Small Organ (breast, thyroid,testicles, prostate)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)	P	P	P		P	B+M; B+PWD; B+CD	1,2,4,5
Musculo-skel. (Superfic.)
Intra-luminal
Other (spec.)
Cardiac Adult
Cardiac Pediatric
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	P	P	P		P	B+M; B+PWD; B+CD	1,2,4,5
Other (spec.)

Table 1.3-5: Diagnostic Ultrasound Indications for Use Form – rC60xi/5-2 Transducer

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

Additional Comments:

1: Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for peripheral nerve block procedures. Color Doppler includes Power/Velocity/Variance. M-Mode includes color M-Mode.

2: Tissue Harmonic Imaging (THI)

3: Tissue Doppler Imaging (TDI)

4: Steep Needle Profiling (Sono MBe)

5: Multi-beam Imaging (SonoMB) in B-Mode

All items marked "P" were previously cleared in 510(k) K153626 (Edge II).

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Table 1.3-6: Diagnostic Ultrasound Indications for Use Form – HFL38xi/13-6 Transducer

System:	FUJIFILM SonoSite Edge II Ultrasound System
Transducer:	HFL38xi/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	ColorDoppler	Combined(Spec.)	Other(Spec.)
Ophthalmic	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Fetal	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Abdominal	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Intra-operative (Abdominalorgans and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Small Organ (breast, thyroid,testicles. prostate)	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Musculo-skel. (Superfic.)	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Intra-luminal
Other (spec.)
Cardiac Adult	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Cardiac Pediatric	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Other (spec.)

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

Additional Comments:

2: Tissue Harmonic Imaging (THI)

3: Tissue Doppler Imaging (TDI)

4: Steep Needle Profiling (Sono MBe)

5: Multi-beam Imaging (SonoMB) in B-Mode

All items marked "P" were previously cleared in 510(k) K153626 (Edge II).

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System:	FUJIFILM SonoSite Edge II Ultrasound System
Transducer:	HFL50x/15-6 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
Abdominal		P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Intra-operative (Abdominalorgans and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric		P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Small Organ (breast, thyroid,testicles. prostate)		P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)		P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Musculo-skel. (Superfic.)		P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Intra-luminal
Other (spec.)
Cardiac Adult
Cardiac Pediatric
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel		P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Other (spec.)

Table 1.3-7: Diagnostic Ultrasound Indications for Use Form – HFL50x/15-6 Transducer

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

Additional Comments:

1: Includes imaging to assistin the placement of needler or other anatomical structures and imaging guidance for peripheral nerve block procedures. Color Doppler includes Power/Velocity/Variance. M-Mode includes color M-Mode.

2: Tissue Harmonic Imaging (THI)

3: Tissue Doppler Imaging (TDI)

4: Steep Needle Profiling (Sono MB

4: Steep Needle Profiling (Sono MBe)
5: Multi-beam Imaging (SonoMB) in B-Mode

All items marked "P" were previously cleared in 510(k) K153626 (Edge II).

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System:	FUJIFILM SonoSite Edge II Ultrasound System
Transducer:	HSL25x/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	ColorDoppler	Combined(Spec.)	Other(Spec.)
Ophthalmic	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Fetal	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Abdominal	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Intra-operative (Abdominalorgans and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Small Organ (breast, thyroid,testicles.prostate)	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Musculo-skel. (Superfic.)	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Intra-luminal
Other (spec.)
Cardiac Adult	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Cardiac Pediatric	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Other (spec.)

Table 1.3-8: Diagnostic Ultrasound Indications for Use Form – HSL25x/13-6 Transducer

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

Additional Comments:

2: Tissue Harmonic Imaging (THI)

3: Tissue Doppler Imaging (TDI)

4: Steep Needle Profiling (Sono MBe)

5: Multi-beam Imaging (SonoMB) in B-Mode

All items marked "P" were previously cleared in 510(k) K153626 (Edge II).

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System:	FUJIFILM SonoSite Edge II Ultrasound System
Transducer:	ICTx/8-5 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		P	B+M; B+PWD; B+CD	1.5

Table 1.3-9: Diagnostic Ultrasound Indications for Use Form - ICTx/8-5 Transducer

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

B+M; B+PWD; B+CD

1,5

Additional Comments:

Abdominal Intra-operative (Abdominal organs and vascular) Intra-operative (Neuro.) Laparoscopic Pediatric 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 Cardiac Pediatric Trans-esophageal (card.) Other (spec.) Peripheral vessel Other (spec.)

1: Includes imaging to assist in the placement of needler or other anatomical structures and imaging guidance for peripheral nerve block procedures. Color Doppler includes Power/Velocity/Variance. M-Mode includes color M-Mode.

2: Tissue Harmonic Imaging (THI)

3: Tissue Doppler Imaging (TDI)

4: Steep Needle Profiling (Sono MBe)

5: Multi-beam Imaging (SonoMB) in B-Mode

All items marked "P" were previously cleared in 510(k) K153626 (Edge II).

{12}------------------------------------------------

System:	FUJIFILM SonoSite Edge II Ultrasound System
Transducer:	L25x/13-6 MHz Transducer
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the humanbody as follows:
Clinical Application	B	M	PWD	CWD	Color Doppler	Combined (Spec.)	Other (Spec.)
Ophthalmic	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Fetal
Abdominal	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Intra-operative (Abdominal organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Small Organ (breast, thyroid, testicles. prostate)	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Musculo-skel. (Superfic.)	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Intra-luminal
Other (spec.)
Cardiac Adult	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Cardiac Pediatric	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Other (spec.)

Table 1.3-10: Diagnostic Ultrasound Indications for Use Form – L25x/13-6 Transducer

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

Additional Comments:

1: Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for peripheral nerve block procedures. Color Doppler includes Power/Velocity/Variance. M-Mode includes color M-Mode.

2: Tissue Harmonic Imaging (THI)

3: Tissue Doppler Imaging (TDI)

4: Steep Needle Profiling (Sono MBe)

5: Multi-beam Imaging (SonoMB) in B-Mode

All items marked "P" were previously cleared in 510(k) K153626 (Edge II).

{13}------------------------------------------------

Table 1.3-11: Diagnostic Ultrasound Indications for Use Form - L38xi/10-5 Transducer, L38xi/10-5 Armored Transducer

System:	FUJIFILM SonoSite Edge II Ultrasound System
Transducer:	L38xi/10-5 MHz Transducer, L38xi/10-5 MHz Armored Transducer
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human
		body as follows:
Clinical Application	Mode of Operation
		ColorCombinedOther
	B	M	PWD	CWD	Doppler	(Spec.)	(Spec.)
Ophthalmic
Fetal
Abdominal	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Intra-operative (Abdominal
organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Small Organ (breast, thyroid,testicles. prostate)	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
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		P	B+M; B+PWD; B+CD	1,4,5
Cardiac Pediatric	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Other (spec.)

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

Additional Comments:

2: Tissue Harmonic Imaging (THI)

3: Tissue Doppler Imaging (TDI)

4: Steep Needle Profiling (Sono MBe)

5: Multi-beam Imaging (SonoMB) in B-Mode

All items marked "P" were previously cleared in 510(k) K153626 (Edge II).

{14}------------------------------------------------

System:	FUJIFILM SonoSite Edge II Ultrasound System
Transducer:	P10x/8-4 MHz Transducer
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body
	as follows:
Clinical Application	Mode of Operation
					Color	Combined	Other
	B	M	PWD	CWD	Doppler	(Spec.)	(Spec.)
Ophthalmic
Fetal	P	P	P		P	B+M; B+PWD; B+CD	1,5
Abdominal	P	P	P		P	B+M; B+PWD; B+CD	1,5
Intra-operative (Abdominalorgans and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P	P		P	B+M; B+PWD; B+CD	1,5
Small Organ (breast, thyroid,testicles.prostate)	P	P	P		P	B+M; B+PWD; B+CD	1,5
Neonatal Cephalic	P	P	P		P	B+M; B+PWD; B+CD	1,5
Adult Cephalic	P	P	P		P	B+M; B+PWD; B+CD	1,5
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)	P	P	P		P	B+M; B+PWD; B+CD	1,5
Musculo-skel. (Superfic.)
Intra-luminal
Other (spec.)
Cardiac Adult	P	P	P	P	P	B+M; B+PWD; B+CWD; B+CD	1,3,5
Cardiac Pediatric	P	P	P	P	P	B+M; B+PWD; B+CWD; B+CD	1,3,5
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	P	P	P		P	B+M; B+PWD; B+CD	1,5
Other (spec.)

Table 1.3-12: Diagnostic Ultrasound Indications for Use Form – P10x/8-4 Transducer

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

Additional Comments:

1: Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for peripheral nerve block procedures . Color Doppler includes Power/Velocity/Variance. M-Mode includes color M-Mode.

2: Tissue Harmonic Imaging (THI)
3: Tissue Doppler Imaging (TDI)

4: Steep Needle Profiling (Sono MBe)

5: Multi-beam Imaging (SonoMB) in B-Mode

All items marked "P" were previously cleared in 510(k) K153626 (Edge II).

{15}------------------------------------------------

System:	FUJIFILM SonoSite Edge II Ultrasound System
Transducer:	P11x/10-5 MHz Transducer
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human bodyas follows:
Clinical Application	Mode of Operation
	B	M	PWD	CWD	ColorDoppler	Combined(Spec.)	Other(Spec.)
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominalorgans and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P			P	B+M; B+CD	1
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
Cardiac Pediatric
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	P	P			P	B+M; B+CD	1
Other (spec.)

Table 1.3-13: Diagnostic Ultrasound Indications for Use Form – P11x/10-5 Transducer

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

Additional Comments:

1: Includes imaging to assistin the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for peripheral nerve block procedures. Color Doppler includes Power/Velocity/Variance. M-Mode includes color M-Mode.

2: Tissue Harmonic Imaging (THI)
3: Tissue Doppler Imaging (TDI)

4: Steep Needle Profiling (Sono MBe)

5: Multi-beam Imaging (SonoMB) in B-Mode

All items marked "P" were previously cleared in 510(k) K153626 (Edge II).

{16}------------------------------------------------

Table 1.3-14: Diagnostic Ultrasound Indications for Use Form – rP19x/5-1 Transducer, rP19x/5-1 Armored Transducer

System:	FUJIFILM SonoSite Edge II Ultrasound System
Transducer:	rP19x/5-1 MHz Transducer, rP19x/5-1 MHz Armored Transducer
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human bodyas follows:
Clinical Application	Mode of Operation
	B	M	PWD	CWD	ColorDoppler	Combined(Spec.)	Other(Spec.)
Ophthalmic	P	P	P		P	B+M; B+PWD; B+CD	1-3
Fetal	P	P	P		P	B+M; B+PWD; B+CD	1-3
Abdominal	P	P	P		P	B+M; B+PWD; B+CD	1-3
Intra-operative (Abdominalorgans and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P	P		P	B+M; B+PWD; B+CD	1-3
Small Organ (breast, thyroid,testicles.prostate)	P	P	P		P	B+M; B+PWD; B+CD	1-3
Neonatal Cephalic	P	P	P		P	B+M; B+PWD; B+CD	1-3
Adult Cephalic	P	P	P		P	B+M; B+PWD; B+CD	1-3
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	P	P	B+M; B+PWD; B+CWD; B+CD	1-3
Cardiac Pediatric	P	P	P	P	P	B+M; B+PWD; B+CWD; B+CD	1-3
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	P	P	P		P	B+M; B+PWD; B+CD	1-3
Other (spec.)

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

Additional Comments:

2: Tissue Harmonic Imaging (THI)

3: Tissue Doppler Imaging (TDI)

4: Steep Needle Profiling (Sono MBe)

5: Multi-beam Imaging (SònoMB) in É-Mode

All items marked "P" were previously cleared in 510(k) K153626 (Edge II).

{17}------------------------------------------------

System:	FUJIFILM SonoSite Edge II Ultrasound System
Transducer:	TEExi/8-3 MHz Transducer
Intended Use :	Diagnostic ultrasound imaging or fluid flow analysis of the human bodyas follows:
Clinical Application	Mode of Operation
	B	M	PWD	CWD	ColorDoppler	Combined(Spec.)	Other(Spec.)
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominalorgans and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric
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
Cardiac Pediatric
Trans-esophageal (card.)	P	P	P	P	P	B+M; B+PWD; B+CWD; B+CD	1,3
Other (spec.)
Peripheral vessel
Other (spec.)

Table 1.3-15: Diagnostic Ultrasound Indications for Use Form – TEExi/8-3 Transducer

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

Additional Comments:

1: Includes imaging to assistin the placementof needles and catheters in vascular or other anatomical structures and imaging guidance for peripheral nerve block procedures. Color Doppler includes Power/Velocity/Variance. M-Mode includes color M-Mode.

2: Tissue Harmonic Imaging (THI)

3: Tissue Doppler Imaging (TDI)

4: Steep Needle Profiling (Sono MBe)

5: Multi-beam Imaging (SonoMB) in B-Mode

All items marked "P" were previously cleared in 510(k) K153626 (Edge II).

{18}------------------------------------------------

Indications for Use

510(k) Number (if known) K162045

Device Name SonoSite SII Ultrasound System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X Prescription Use (Part21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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{19}------------------------------------------------

SonoSite SII Ultrasound System:

The following are the Indications for Use for the SonoSite SII Ultrasound System

Table 1.3-16: Diagnostic Ultrasound Indications for Use Form - FUJIFILM SonoSite SII Ultrasound System

System:	FUJIFILM SonoSite SII Ultrasound System
Transducer:	N/A
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human bodyas follows:
Clinical Application	Mode of Operation
	B	M	PWD	CWD	ColorDoppler	Combined(Spec.)	Other(Spec.)
Ophthalmic	P	P			P	B+M; B+CD	1,4,5
Fetal	P	P			P	B+M; B+CD	1,2,4,5
Abdominal	P	P			P	B+M; B+CD	1,2,4,5
Intra-operative (Abdominalorgans and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P			P	B+M; B+CD	1,2,4,5
Small Organ (breast, thyroid,testicles, prostate)	P	P			P	B+M; B+CD	1,2,4,5
Neonatal Cephalic	P	P			P	B+M; B+CD	1,5
Adult Cephalic	P	P			P	B+M; B+CD	1,5
Trans-rectal	N	N			N	B+M; B+CD	1,5
Trans-vaginal	P	P			P	B+M; B+CD	1,5
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)	P	P			P	B+M; B+CD	1,2,4,5
Musculo-skel. (Superfic.)	P	P			P	B+M; B+CD	1,4,5
Intra-luminal
Other (spec.)
Cardiac Adult	P	P			P	B+M; B+CD	1,2,4,5
Cardiac Pediatric	P	P			P	B+M; B+CD	1,2,4,5
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	P	P			P	B+M; B+CD	1,2,4,5
Other (spec.)

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

Additional Comments:

1: Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for peripheral nerve block procedures. Color Doppler includes Power/Velocity/Variance. M-Mode includes color M-Mode.

2: Tissue Harmonic Imaging (THI)
3: Tissue Doppler Imaging (TDI)
4: Steep Needle Profiling (Sono MBe)
5: Multi-beam Imaging (SonoMB) in B-Mode

All items marked "P" were previously cleared in 510(k) K160734 (SII).

{20}------------------------------------------------

Table 1.3-17: Diagnostic Ultrasound Indications for Use Form – C8x/8-5 MHz Transducer

System:	FUJIFILM SonoSite SII Ultrasound System
Transducer:	C8x/8-5 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
Abdominal
Intra-operative (Abdominal organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric
Small Organ (breast, thyroid, testicles, prostate)
Neonatal Cephalic
Adult Cephalic
Trans-rectal	P	P			P	B+M; B+CD	1,5
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
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: Includes imaging to assistin the placementofneedles and catheters in vascular or other anatomical structures and imaging guidance for peripheral nerve block procedures . Color Doppler includes Power/Velocity/Variance. M-Mode includes color M-Mode.

2: Tissue Harmonic Imaging (THI)

3: Tissue Doppler Imaging (TDI)

4: Steep Needle Profiling (Sono MBe)

5: Multi-beam Imaging (SonoMB) in B-Mode

All items marked "P" were previously cleared in 510(k) K133454 (Edge).

{21}------------------------------------------------

Table 1.3-18: Diagnostic Ultrasound Indications for Use Form – C11x/8-5 MHz Transducer

System:	FUJIFILM SonoSite SII Ultrasound System
Transducer:	C11x/8-5 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
Fetal
Abdominal	P	P			P	B+M; B+CD	1,5
Intra-operative (Abdominalorgans and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P			P	B+M; B+CD	1,5
Small Organ (breast, thyroid,testicles, prostate)
Neonatal Cephalic	P	P			P	B+M; B+CD	1,5
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Intra-luminal
Other (spec.)
Cardiac Adult
Cardiac Pediatric	P	P			P	B+M; B+CD	1,5
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	P	P			P	B+M; B+CD	1,5
Other (spec.)

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

Additional Comments:

2: Tissue Harmonic Imaging (THI)

3: Tissue Doppler Imaging (TDI)

4: Steep Needle Profiling (Sono MBe)

5: Multi-beam Imaging (SonoMB) in B-Mode

All items marked "P" were previously cleared in 510(k) K160734 (SII).

{22}------------------------------------------------

Table 1.3-19: Diagnostic Ultrasound Indications for Use Form – C35x/8-3 MHz Transducer

System:	FUJIFILM SonoSite SII Ultrasound System
Transducer:	C35x/8-3 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
Fetal	P	P			P	B+M; B+CD	1,4,5
Abdominal	P	P			P	B+M; B+CD	1,4,5
Intra-operative (Abdominalorgans and vascular)

Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P			P	B+M; B+CD	1,4,5
Small Organ (breast, thyroid,testicles, prostate)

Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)	P	P			P	B+M; B+CD	1,4,5
Musculo-skel. (Superfic.)	P	P			P	B+M; B+CD	1,4,5
Intra-luminal
Other (spec.)
Cardiac Adult
Cardiac Pediatric
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	P	P			P	B+M; B+CD	1,4,5
Other (spec.)

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

Additional Comments:

1: Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for peripheral nerve block procedures . Color Doppler includes Power/Velocity/Variance. M-Mode includes color M-Mode.

2: Tissue Harmonic Imaging (THI)
3: Tissue Doppler Imaging (TDI)

4: Steep Needle Profiling (Sono MBe)

5: Multi-beam Imaging (SonoMB) in B-Mode

All items marked "P" were previously cleared in 510(k) K160406 (FC1).

{23}------------------------------------------------

Table 1.3-20: Diagnostic Ultrasound Indications for Use Form – rC60xi/5-2 MHz Transducer, rC60xi/5-2 MHz Armored Transducer

System:	FUJIFILM SonoSite SII Ultrasound System
Transducer:	rC60xi/5-2 MHz Transducer, rC60xi/5-2 MHz Armored 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
Fetal	P	P			P	B+M; B+CD	1,2,4,5
Abdominal	P	P			P	B+M; B+CD	1,2,4,5
Intra-operative (Abdominalorgans and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P			P	B+M; B+CD	1,2,4,5
Small Organ (breast, thyroid,testicles, prostate)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)	P	P			P	B+M; B+CD	1,2,4,5
Musculo-skel. (Superfic.)
Intra-luminal
Other (spec.)
Cardiac Adult
Cardiac Pediatric
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	P	P			P	B+M; B+CD	1,2,4,5
Other (spec.)

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

Additional Comments:

2: Tissue Harmonic Imaging (THI)

3: Tissue Doppler Imaging (TDI)

4: Steep Needle Profiling (Sono MBe)

5: Multi-beam Imaging (SonoMB) in B-Mode

All items marked "P" were previously cleared in 510(k) K160734 (SII).

{24}------------------------------------------------

Table 1.3-21: Diagnostic Ultrasound Indications for Use Form – HFL38xi/13-6 MHz Transducer

System:	FUJIFILM SonoSite SII Ultrasound System
Transducer:	HFL38xi/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	ColorDoppler	Combined(Spec.)	Other(Spec.)
Ophthalmic	P	P			P	B+M; B+CD	1,4,5
Fetal	P	P			P	B+M; B+CD	1,4,5
Abdominal	P	P			P	B+M; B+CD	1,4,5
Intra-operative (Abdominalorgans and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P			P	B+M; B+CD	1,4,5
Small Organ (breast, thyroid,testicles, prostate)	P	P			P	B+M; B+CD	1,4,5
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)	P	P			P	B+M; B+CD	1,4,5
Musculo-skel. (Superfic.)	P	P			P	B+M; B+CD	1,4,5
Intra-luminal
Other (spec.)
Cardiac Adult	P	P			P	B+M; B+CD	1,4,5
Cardiac Pediatric	P	P			P	B+M; B+CD	1,4,5
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	P	P			P	B+M; B+CD	1,4,5
Other (spec.)

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

Additional Comments:

2: Tissue Harmonic Imaging (THI)

3: Tissue Doppler Imaging (TDI)

4: Steep Needle Profiling (Sono MBe)

5: Multi-beam Imaging (SonoMB) in B-Mode

All items marked "P" were previously cleared in 510(k) K160734 (SII).

{25}------------------------------------------------

Table 1.3-22: Diagnostic Ultrasound Indications for Use Form – HFL50x/15-6 MHz Transducer

System:	FUJIFILM SonoSite SII Ultrasound System
Transducer:	HFL50x/15-6 MHz Transducer
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the humanbody as follows:
Clinical Application							Mode of Operation	Other(Spec.)
	B	M	PWD	CWD	ColorDoppler	Combined(Spec.)
Ophthalmic
Fetal
Abdominal	P	P			P	B+M; B+CD	1,4,5
Intra-operative (Abdominalorgans and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P			P	B+M; B+CD	1,4,5
Small Organ (breast, thyroid,testicles, prostate)	P	P			P	B+M; B+CD	1,4,5
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)	P	P			P	B+M; B+CD	1,4,5
Musculo-skel. (Superfic.)	P	P			P	B+M; B+CD	1,4,5
Intra-luminal
Other (spec.)
Cardiac Adult
Cardiac Pediatric
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	P	P			P	B+M; B+CD	1,4,5
Other (spec.)

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

Additional Comments:

2: Tissue Harmonic Imaging (THI)

3: Tissue Doppler Imaging (TDI)

4: Steep Needle Profiling (Sono MBe)

5: Multi-beam Imaging (SonoMB) in B-Mode

All items marked "P" were previously cleared in 510(k) K160734 (SII).

{26}------------------------------------------------

Table 1.3-23: Diagnostic Ultrasound Indications for Use Form – HSL25x/13-6 MHz Transducer

System:	FUJIFILM SonoSite SII Ultrasound System
Transducer:	HSL25x/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	ColorDoppler	Combined(Spec.)	Other(Spec.)
Ophthalmic	P	P			P	B+M; B+CD	1,4,5
Fetal	P	P			P	B+M; B+CD	1,4,5
Abdominal	P	P			P	B+M; B+CD	1,4,5
Intra-operative (Abdominalorgans and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P			P	B+M; B+CD	1,4,5
Small Organ (breast, thyroid,testicles, prostate)	P	P			P	B+M; B+CD	1,4,5
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)	P	P			P	B+M; B+CD	1,4,5
Musculo-skel. (Superfic.)	P	P			P	B+M; B+CD	1,4,5
Intra-luminal
Other (spec.)
Cardiac Adult	P	P			P	B+M; B+CD	1,4,5
Cardiac Pediatric	P	P			P	B+M; B+CD	1,4,5
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	P	P			P	B+M; B+CD	1,4,5
Other (spec.)

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

Additional Comments:

2: Tissue Harmonic Imaging (THI)

3: Tissue Doppler Imaging (TDI)

4: Steep Needle Profiling (Sono MBe)

5: Multi-beam Imaging (SonoMB) in B-Mode

All items marked "P" were previously cleared in 510(k) K160734 (SII).

{27}------------------------------------------------

Table 1.3-24: Diagnostic Ultrasound Indications for Use Form – ICTx/8-5 MHz Transducer

System:	FUJIFILM SonoSite SII Ultrasound System
Transducer:	ICTx/8-5 MHz Transducer
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the humanbody as follows:
Clinical Application	B	M	PWD	CWD	Color Doppler	Combined (Spec.)	Other (Spec.)
Ophthalmic
Fetal	P	P			P	B+M; B+CD	1,5
Abdominal
Intra-operative (Abdominal organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric
Small Organ (breast, thyroid, testicles, prostate)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal	P	P			P	B+M; B+CD	1,5
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
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:

2: Tissue Harmonic Imaging (THI)

3: Tissue Doppler Imaging (TDI)

4: Steep Needle Profiling (Sono MBe)

5: Multi-beam Imaging (SonoMB) in B-Mode

All items marked "P" were previously cleared in 510(k) K160734 (SII).

{28}------------------------------------------------

Table 1.3-25: Diagnostic Ultrasound Indications for Use Form – L25x/13-6 MHz Transducer

System:	FUJIFILM SonoSite SII Ultrasound System
Transducer:	L25x/13-6 MHz Transducer
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the humanbody as follows:
Clinical Application	B	M	PWD	CWD	ColorDoppler	Combined(Spec.)	Other(Spec.)
Ophthalmic	P	P			P	B+M; B+CD	1,4,5
Fetal	P	P
Abdominal	P	P			P	B+M; B+CD	1,4,5
Intra-operative (Abdominalorgans and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P			P	B+M; B+CD	1,4,5
Small Organ (breast, thyroid,testicles, prostate)	P	P			P	B+M; B+CD	1,4,5
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)	P	P			P	B+M; B+CD	1,4,5
Musculo-skel. (Superfic.)	P	P			P	B+M; B+CD	1,4,5
Intra-luminal
Other (spec.)
Cardiac Adult	P	P			P	B+M; B+CD	1,4,5
Cardiac Pediatric	P	P			P	B+M; B+CD	1,4,5
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	P	P			P	B+M; B+CD	1,4,5
Other (spec.)

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

Additional Comments:

2: Tissue Harmonic Imaging (THI)

3: Tissue Doppler Imaging (TDI)

4: Steep Needle Profiling (Sono MBe)

5: Multi-beam Imaging (SonoMB) in B-Mode

All items marked "P" were previously cleared in 510(k) K160734 (SII).

{29}------------------------------------------------

Table 1.3-26: Diagnostic Ultrasound Indications for Use Form - L38xi/10-5 MHz Transducer, L38xi/10-5 MHz Armored Transducer

System:	FUJIFILM SonoSite SII Ultrasound System
Transducer:	L38xi/10-5 MHz Transducer, L38xi/10-5 MHz Armored 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	ColorDoppler	Combined(Spec.)	Other(Spec.)
Ophthalmic
Fetal
Abdominal	P	P			P	B+M; B+CD	1,4,5
Intra-operative (Abdominalorgans and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P			P	B+M; B+CD	1,4,5
Small Organ (breast, thyroid,testicles, prostate)	P	P			P	B+M; B+CD	1,4,5
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	1,4,5
Cardiac Pediatric	P	P			P	B+M; B+CD	1,4,5
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	P	P			P	B+M; B+CD	1,4,5
Other (spec.)

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

Additional Comments:

2: Tissue Harmonic Imaging (THI)

3: Tissue Doppler Imaging (TDI)

4: Steep Needle Profiling (Sono MBe)

5: Multi-beam Imaging (SonoMB) in B-Mode

All items marked "P" were previously cleared in 510(k) K160734 (SII).

{30}------------------------------------------------

Table 1.3-27: Diagnostic Ultrasound Indications for Use Form – P10x/8-4 MHz Transducer

System:	FUJIFILM SonoSite SII Ultrasound System
Transducer:	P10x/8-4 MHz Transducer
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human bodyas follows:
Clinical Application	Mode of Operation
	B	M	PWD	CWD	ColorDoppler	Combined(Spec.)	Other(Spec.)
Ophthalmic	P	P			P
Fetal	P	P			P	B+M; B+CD	1,5
Abdominal	P	P			P	B+M; B+CD	1,5
Intra-operative (Abdominalorgans and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P			P	B+M; B+CD	1,5
Small Organ (breast, thyroid,testicles, prostate)	P	P			P	B+M; B+CD	1,5
Neonatal Cephalic	P	P			P	B+M; B+CD	1,5
Adult Cephalic	P	P			P	B+M; B+CD	1,5
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)	P	P			P	B+M; B+CD	1,5
Musculo-skel. (Superfic.)
Intra-luminal
Other (spec.)
Cardiac Adult	P	P			P	B+M; B+CD	1,5
Cardiac Pediatric	P	P			P	B+M; B+CD	1,5
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	P	P			P	B+M; B+CD	1,5
Other (spec.)

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

Additional Comments:

2: Tissue Harmonic Imaging (THI)

3: Tissue Doppler Imaging (TDI)

4: Steep Needle Profiling (Sono MBe)

5: Multi-beam Imaging (ŠònoMB) in É-Mode

All items marked "P" were previously cleared in 510(k) K160734 (SII).

{31}------------------------------------------------

Table 1.3-28: Diagnostic Ultrasound Indications for Use Form – P11x/10-5 MHz Transducer

System:	FUJIFILM SonoSite SII Ultrasound System
Transducer:	P11x/10-5 MHz Transducer
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human bodyas follows:
Clinical Application	Mode of Operation
	B	M	PWD	CWD	ColorDoppler	Combined(Spec.)	Other(Spec.)
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominalorgans and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P			P	B+M; B+CD	1
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
Cardiac Pediatric
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	P	P			P	B+M; B+CD	1
Other (spec.)

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

Additional Comments:

2: Tissue Harmonic Imaging (THI)

3: Tissue Doppler Imaging (TDI)

4: Steep Needle Profiling (Sono MBe)

5: Multi-beam Imaging (SonoMB) in B-Mode

All items marked "P" were previously cleared in 510(k) K160734 (SII).

{32}------------------------------------------------

Table 1.3-29: Diagnostic Ultrasound Indications for Use Form – rP19x/5-1 MHz Transducer, rP19x/5-1 MHz Armored Transducer

System:	FUJIFILM SonoSite SII Ultrasound System
Transducer:	rP19x/5-1 MHz Transducer, rP19x/5-1 MHz Armored Transducer
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human bodyas follows:
Clinical Application					Mode of Operation
	B	M	PWD	CWD	ColorDoppler	Combined(Spec.)	Other(Spec.)
Ophthalmic
Fetal	P	P			P	B+M; B+CD	1,2
Abdominal	P	P			P	B+M; B+CD	1,2
Intra-operative (Abdominalorgans and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P			P	B+M; B+CD	1,2
Small Organ (breast, thyroid,testicles, prostate)	P	P			P	B+M; B+CD	1,2
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	1,2
Cardiac Pediatric	P	P			P	B+M; B+CD	1,2
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	P	P			P	B+M; B+CD	1,2
Other (spec.)

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

Additional Comments:

2: Tissue Harmonic Imaging (THI)

3: Tissue Doppler Imaging (TDI)

4: Steep Needle Profiling (Sono MBe)

5: Multi-beam Imaging (SònoMB) in É-Mode

All items marked "P" were previously cleared in 510(k) K160734 (SII).

{33}------------------------------------------------

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:	Jordan Grimmer
	Regulatory Affairs Specialist
E-mail:	jordan.grimmer@fujifilm.com
Telephone:	(425) 951-6984
Facsimile:	(425) 951-1201
Date prepared:	July 12, 2016

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 Edge II Ultrasound System (subject to change) SonoSite SII Ultrasound System (subject to change)

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:

SonoSite Edge II Ultrasound System	K153626
SonoSite SII Ultrasound System	K160734
SonoSite Edge Ultrasound System	K133454
FUJIFILM FC1 Ultrasound System	K160406

4) Device Description:

SONOSITE EDGE II ULTRASOUND SYSTEM:

The SonoSite Edge II Ultrasound System is a portable laptop style, full featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. Edge II is a custom fabricated digital electronic design that readily lends itself to be configured for specific ultrasound imaging applications through different system feature selections. Edge II can operate on either battery or AC power.

{34}------------------------------------------------

SONOSITE SII ULTRASOUND SYSTEM

The SonoSite SII Ultrasound System is a mountable style, full featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. SII is a custom fabricated digital electronic design that readily lends itself to be configured for specific ultrasound imaging applications through different system feature selections. SII can operate on either battery or AC power.

5) Intended Use:

SONOSITE EDGE II ULTRASOUND SYSTEM

Ophthalmic Fetal - OB/GYN Abdominal Pediatric Small Organ (breast, thyroid, testicle, prostate) Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Cardiac Adult Cardiac Pediatric Trans-esophageal (cardiac) Peripheral Vessel

SONOSITE SII ULTRASQUND SYSTEM

Ophthalmic Fetal - OB/GYN Abdominal Pediatric Small Organ (breast, thyroid, testicle, prostate) Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Cardiac Adult Cardiac Pediatric Peripheral Vessel

Page 282 of 5512

{35}------------------------------------------------

6) Technological Characteristics:

SONOSITE EDGE II ULTRASOUND SYSTEM:

SonoSite Edge II, Edge, and FC1 Ultrasound Systems are all Track 3 devices that employ the same fundamental scientific technology. A comparison table is provided below.

Feature	SonoSite Edge IIUltrasoundSystem(This submission)	SonoSite Edge IIUltrasoundSystem(K153626)	SonoSite EdgeUltrasoundSystem(K133454)	FUJIFILM FC1UltrasoundSystem(K160406)
Intended Use	Diagnostic ultrasoundimaging or fluid flowanalysis of the humanbody	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	OpthalmicFetal - OB/GYN	OpthalmicFetal - OB/GYN	OpthalmicFetal - OB/GYN	Fetal – OB/GYN
	Abdominal	Abdominal	AbdominalIntraoperative(abdominal organs andvascular)Intra-operative (Neuro.)	AbdominalIntra-operative(Abdominal organs andvascular)
	PediatricSmall Organ (breast,thyroid, testicle,prostate)	PediatricSmall Organ (breast,thyroid, testicle,prostate)	PediatricSmall Organ (breast,thyroid, testicle,prostate)	PediatricSmall Organ (breast,thyroid, testicles,prostate)
	Neonatal CephalicAdult CephalicTrans-Rectal	Neonatal CephalicAdult Cephalic	Neonatal CephalicAdult CephalicTrans-Rectal	Neonatal Cephalic
	Trans-Vaginal	Trans-Vaginal	Trans-Vaginal	Trans-vaginal
	Musculo-skeletal(Conventional)	Musculo-skeletal(Conventional)	Musculo-skeletal(Conventional)	Musculo-skel.(Convent.)
	Musculo-skeletal	Musculo-skeletal	Musculo-skeletal	Musculo-skel.
	(Superficial)	(Superficial)	(Superficial)	(Superfic.)
	Cardiac Adult	Cardiac Adult	Cardiac Adult	Cardiac Adult
	Cardiac Pediatric	Cardiac Pediatric	Cardiac Pediatric	Cardiac Pediatric
	Trans-esophageal	Trans-esophageal	Trans-esophageal
	(cardiac)	(cardiac)	(cardiac)
	Peripheral Vessel	Peripheral Vessel	Peripheral Vessel	Peripheral Vessel
	Needle	Needle	Needle	Needle
	guidance	guidance	guidance	guidance
Transducer	Linear Array	Linear Array	Linear Array	Linear Array
Types	Curved Linear Array	Curved Linear Array	Curved Linear Array	Curved Linear Array
	IntracavitaryPhased Array	IntracavitaryPhased Array	IntracavitaryPhased Array	IntracavitaryPhased Array
			Static Probes
	Trans-esophageal	Trans-esophageal	Trans-esophageal
Transducer	1.0 - 15.0 MHz	1.0 – 15.0 MHz	1.0 — 15.0 MHz	1.0 – 15.0 MHz
Frequency
Global	Ispta.3: 598.9 (HFL50x)	Ispta.3: 598.9 (HFL50x)	Ispta.3: 708.8 (TEEx)	lspta.3: 434mW/cm2
Maximum	TI Type: TIB (rP19x)	TI Type: TIB (rP19x)	TI Type: TIB (L38xi)	TI Type: TIC
Outputs/Worst	TI Value: 4.98 (rP19x)	TI Value: 4.98 (rP19x)	TI Value: 4.06 (L38xi)	TI Value: 1.8
Case Setting	MI: 1.7 (rP19x)	MI: 1.7 (rP19x)	MI: 1.51 (P21x)	MI: 1.1
	Ipa.3@MI Max: 776	Ipa.3@MI Max: 776	Ipa.3@MI Max: 776	Ipa.3@MI Max: 265.4
	(L38xi)	(L38xi)	(L38xi)	W/cm2
Acoustic	Display Feature for	Display Feature for	Display Feature for	Display Feature for
Feature	SonoSite Edge IIUltrasoundSystem(This submission)	SonoSite Edge IIUltrasoundSystem(K153626)	SonoSite EdgeUltrasoundSystem(K133454)	FUJIFILM FC1UltrasoundSystem(K160406)
Output Display& FDA Limits	Higher OutputsMI Output DisplayTI Output Display	Higher OutputsMI Output DisplayTI Output Display	Higher OutputsMI Output DisplayTI Output Display	Higher OutputsMI Output DisplayTI Output Display
Modes ofOperation	B-mode GrayscaleImagingTissue HarmonicImagingM-modeColor M-Mode	B-mode GrayscaleImagingTissue HarmonicImagingM-modeColor M-Mode	B-mode GrayscaleImagingTissue HarmonicImagingM-modeColor M-Mode	B-ModePulse InversionHarmonic ImagingCompound HarmonicImagingSpatial CompoundImagingM-modeVelocity Color Doppler
	Color Power DopplerZoomCombination ModesPulsed Wave (PW)DopplerContinuous Wave (CW)DopplerSonoHD2 NoiseReductionSonoMB/MBe ImageCompoundingSteered CW DopplerVelocity Color DopplerTissue Doppler Imaging(TDI)	Color Power DopplerZoomCombination ModesPulsed Wave (PW)DopplerContinuous Wave (CW)DopplerSonoHD2 NoiseReductionSonoMB/MBe ImageCompoundingSteered CW DopplerVelocity Color DopplerTissue Doppler Imaging(TDI)	Color Power DopplerZoomCombination ModesPulsed Wave (PW)DopplerContinuous Wave (CW)DopplerSonoHD2 NoiseReductionSonoMB/MBe ImageCompoundingSteered CW DopplerVelocity Color DopplerTissue Doppler Imaging(TDI)	Color Power DopplerDirectional Color PowerDopplerPulsed Wave DopplerPulsed Wave TissueDopplerContinuous WaveDoppler, ECG
PW Doppler	Available on all imagingtransducers exceptP11x	Available on all imagingtransducers exceptP11x	Available on all imagingtransducers except D2xand P11x	Available on all imagingtransducers.SimultaneousDuplexTriplexSimultaneous B-modeand PW DopplerHigh PRF capability
	Adjustable samplevolume size: 1.0 – 25mmSimultaneous or duplexmode of operationSimultaneous B-modeand PW DopplerHigh PRF capability	Adjustable samplevolume size: 1.0 – 25mmSimultaneous or duplexmode of operationSimultaneous B-modeand PW DopplerHigh PRF capability	Adjustable samplevolume size: 1.0 – 25mmSimultaneous or duplexmode of operationSimultaneous B-modeand PW DopplerHigh PRF capability
CW Doppler	Available on P10x,rP19x, TEExi	Available on P10x,rP19x, TEExi	Available on C11x, D2x,P10x, P21x, TEEx	Available on P21xSimultaneousDuplexTriplexSimultaneous B-modeand CW Doppler
	Simultaneous or duplexmode of operationSimultaneous B-modeand CW Doppler	Simultaneous or duplexmode of operationSimultaneous B-modeand CW Doppler	Simultaneous or duplexmode of operationSimultaneous B-modeand CW Doppler
Velocity ColorDoppler	Available on alltransducers	Available on alltransducers	Available on alltransducers except D2x	Available on alltransducers
ECG Feature	3-lead ECG input, orECG Slave Cable	3-lead ECG input, orECG Slave Cable	3-lead ECG input	One 3-lead ECG input,orOne external ECG input,orOne other physio input
DICOM	DICOM 3.0 Store, Print,Modality Worklist,Perform Procedure Step	DICOM 3.0 Store, Print,Modality Worklist,Perform Procedure Step	DICOM 3.0 Store, Print,and Modality WorklistPerform Procedure Step	DICOM 3.0 Store, Print,and Modality Worklistservice class user
Feature	SonoSite Edge IIUltrasoundSystem(This submission)	SonoSite Edge IIUltrasoundSystem(K153626)	SonoSite EdgeUltrasoundSystem(K133454)	FUJIFILM FC1UltrasoundSystem(K160406)
	(PPS), Storage	(PPS), Storage		features
	Commitment	Commitment
IMTMeasurement	Not available	Not available	SonoCalc IMT providesthe capability forautomatedmeasurement of intima-media thickness (IMT) ofthe carotid artery. IMTfunctionality is availableboth on the ultrasoundsystem and in a standalone software programthat runs on a personalcomputer.	Manual IMTmeasurementfunctionality available.
#TransmitChannels	128 digital channels	128 digital channels	128 digital channels	64 digital channels
#ReceiveChannels	64 digital channels(128 digital channelsusing Synthetic	64 digital channels(128 digital channelsusing Synthetic	64 digital channels(128 digital channelsusing Synthetic	64 digital channels
	Aperture)	Aperture)	Aperture)
Patient ContactMaterials	Transducers:Acrylonitrile-butadien-styrene (ABS)Cycoloy	Transducers:Acrylonitrile-butadien-styrene (ABS)Cycoloy	Transducers:Acrylonitrile-butadien-styrene (ABS)CycoloyDow Medical Adhesive,Type A	Transducers:Acrylonitrile-butadien-styrene (ABS)Dow Medical Adhesive,Type A
	Epoxy paste adhesivePolyethylene (PE)lonomerPolyetheretherketone(PEEK)PolycarbonatePolysulfone UDELP1700PolyurethanePoly-Vinyl-Chloride(PVC)Silicone RTV AdhesiveSilicone RubberUrethaneNeedle Guides:Acetal copolymerAcrylonitrile-butadien-styrene (ABS)	Epoxy paste adhesivePolyethylene (PE)lonomerPolyetheretherketone(PEEK)PolycarbonatePolysulfone UDELP1700PolyurethanePoly-Vinyl-Chloride(PVC)Silicone RTV AdhesiveSilicone RubberUrethaneNeedle Guides:Acetal copolymerAcrylonitrile-butadien-styrene (ABS)	Epoxy paste adhesivePolyethylene (PE)lonomerPolyetheretherketone(PEEK)PolycarbonatePolysulfone UDELP1700PolyurethanePoly-Vinyl-Chloride(PVC)Silicone RTV AdhesiveSilicone RubberUrethaneNeedle Guides:Acetal copolymerAcrylonitrile-butadien-styrene (ABS)	Epoxy paste adhesive,Polysulfone UDELP1700PolyurethanePoly-Vinyl-Chloride(PVC)Silicone RubberUrethaneNeedle Guides:Acetal copolymerAcrylonitrile-butadien-styrene (ABS)
Product SafetyCertification	AAMI/ANSI ES60601-1:2005 (R2012)IEC 60601-2-37: 2007CAN/CSA C22.2 No.60601-1:08NEMA UD2-2004IEC 62359:2010	AAMI/ANSI ES60601-1:2005 (R2012)IEC 60601-2-37: 2007CAN/CSA C22.2 No.60601-1:08NEMA UD2-2004IEC 62359:2010	AAMI/ANSI ES60601-1:2005 (R2012)IEC 60601-2-37: 2007CAN/CSA C22.2 No.60601-1:08NEMA UD2-2004AIUM RTD2-2004(NEMA UD3-2004(R2009))	AAMI/ANSI ES60601-1:2005 (R2012)IEC 60601-2-37: 2007CAN/CSA C22.2 No.601.1JIS T 0601-1, JIS T1507CEI/IEC 61157ANSI/AAMI EC53
Feature	SonoSite Edge IIUltrasoundSystem(This submission)	SonoSite Edge IIUltrasoundSystem(K153626)	SonoSite EdgeUltrasoundSystem(K133454)	FUJIFILM FC1UltrasoundSystem(K160406)
				NEMA UD2-2004AIUM RTD2-2004(NEMA UD3-2004(R2009))
EMCCompliance	AAMI / ANSI / IEC60601-1-2:2007(R)2012CISPR 11, Group 1,Class A	AAMI / ANSI / IEC60601-1-2:2007(R)2012CISPR 11, Group 1,Class A	AAMI / ANSI / IEC60601-1-2:2007(R)2012CISPR 11, Group 1,Class A	IEC 60601-1-2:2007CISPR 11IEC 61000-4 pt 2-5
DICOM	NEMA PS3.15 2003	NEMA PS3.15 2003	NEMA PS3.15 2003	NEMA PS3.15 2003
AirborneEquipmentStandards	RTCA/DO160 (section21)	RTCA/DO160 (section21)	RTCA/DO160 (section21)	None
SystemCharacteristics	Edge II:Beamformer 128/128using SA (configurable)Hand held display andcontrolSingle 12.1" LiquidCrystal Display (LCD)256 gray shades onLCD2 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,50/60 Hz, 15VDC outputVarious obstetrical,cardiac, volume, M-mode, PW and CWDoppler measurementand calculationpackagesECG acquisition anddisplay capabilitiesCW/PW Doppler AudioSpectral Doppler Audioand image storage onremovable mediaWireless 802.11 (b/g/n)	Edge II:Beamformer 128/128using SA (configurable)Hand held display andcontrolSingle 12.1" LiquidCrystal Display (LCD)256 gray shades onLCD2 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,50/60 Hz, 15VDC outputVarious obstetrical,cardiac, volume, M-mode, PW and CWDoppler measurementand calculationpackagesECG acquisition anddisplay capabilitiesCW/PW Doppler AudioSpectral Doppler Audioand image storage onremovable mediaWireless 802.11 (b/g/n)	Edge:Beamformer 128/128using SA (configurable)Hand held display andcontrolSingle 12.1" LiquidCrystal Display (LCD)256 gray shades onLCD2 USB portsDimensions: 12.9"(W) x12.4" (L) x 2.5"(H)Weight: 8.5 lbsSystem operates viabattery or AC powerBattery life: 1.5 - 4 houroperation per charge100 - 240V options,50/60 Hz, 15VDC outputVarious obstetrical,cardiac, volume, M-mode, PW and CWDoppler measurementand calculationpackagesECG acquisition anddisplay capabilitiesCW/PW Doppler AudioSpectral Doppler Audioand image storage onremovable mediaWireless 802.11 (b/g/n)	FC1:Beamformer 64/64Hand held display andcontrolSingle 12.1" LiquidCrystal Display (LCD)256 gray shades onLCD4 USB portsDimensions: 12.24"(W)x 13.03" (L) x 3.03"(H)Weight: 11.9 lbsSystem operates viabattery or AC powerBattery operated (1.5 - 4hour operation percharge)100 - 240V options,50/60 Hz, 15VDC outputVarious obstetrical,cardiac, volume, M-mode, PW and CWDoppler measurementand calculationpackagesECG acquisition anddisplay capabilitiesCW/PW Doppler AudioSpectral Doppler Audioand image storage onremovable media
Feature	SonoSite Edge IIUltrasoundSystem(This submission)	SonoSite Edge IIUltrasoundSystem(K153626)	SonoSite EdgeUltrasoundSystem(K133454)	FUJIFILM FC1UltrasoundSystem(K160406)
	support for imagetransfer	support for imagetransfer	support for imagetransfer	Wireless 802.11 (a\b\g)support for imagetransfer
510(k) Track	Track 3	Track 3	Track 3	Track 3

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SONOSITE SII ULTRASOUND SYSTEM

SonoSite SII, Edge, and FC1 Ultrasound Systems are all Track 3 devices that employ the same fundamental scientific technology. A comparison table is provided below.

Feature	SonoSite SIIUltrasoundSystem(This submission)	SonoSite SIIUltrasoundSystem(K160734)	SonoSite EdgeUltrasoundSystem(K133454)	FUJIFILM FC1UltrasoundSystem(K160406)
Intended Use	Diagnostic ultrasoundimaging or fluid flowanalysis of the humanbody	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	OpthalmicFetal – OB/GYNAbdominalPediatricSmall Organ (breast,thyroid, testicle, prostate)Neonatal CephalicAdult CephalicTrans-RectalTrans-VaginalMusculo-skeletal(Conventional)Musculo-skeletal(Superficial)Cardiac AdultCardiac PediatricPeripheral VesselNeedleguidance	OpthalmicFetal - OB/GYNAbdominalPediatricSmall Organ (breast,thyroid, testicle, prostate)Neonatal CephalicAdult CephalicTrans-VaginalMusculo-skeletal(Conventional)Musculo-skeletal(Superficial)Cardiac AdultCardiac PediatricPeripheral VesselNeedleguidance	OpthalmicFetal - OB/GYNAbdominalIntraoperative(abdominal organs andvascular)Intra-operative (Neuro.)PediatricSmall Organ (breast,thyroid, testicle, prostate)Neonatal CephalicAdult CephalicTrans-RectalTrans-VaginalMusculo-skeletal(Conventional)Musculo-skeletal(Superficial)Cardiac AdultCardiac PediatricTrans-esophageal(cardiac)Peripheral VesselNeedleguidance	Fetal - OB/GYNAbdominalIntra-operative(Abdominal organs andvascular)PediatricSmall Organ (breast,thyroid, testicles,prostate)Neonatal CephalicTrans-vaginalMusculo-skel. (Convent.)Musculo-skel. (Superfic.)Cardiac AdultCardiac PediatricPeripheral VesselNeedleguidance
TransducerTypes	Linear ArrayCurved Linear ArrayIntracavitaryPhased Array	Linear ArrayCurved Linear ArrayIntracavitaryPhased Array	Linear ArrayCurved Linear ArrayIntracavitaryPhased ArrayStatic Probes	Linear ArrayCurved Linear ArrayIntracavitaryPhased Array
Feature	SonoSite SIIUltrasoundSystem(This submission)	SonoSite SIIUltrasoundSystem(K160734)	SonoSite EdgeUltrasoundSystem(K133454)	FUJIFILM FC1UltrasoundSystem(K160406)
			Trans-esophageal
TransducerFrequency	1.0 - 15.0 MHz	1.0 - 15.0 MHz	1.0 - 15.0 MHz	1.0 - 15.0 MHz
GlobalMaximumOutputs/WorstCase Setting	Ispta.3: 420.2 (L38xi)TI Type: TIC (rC60xi)TI Value: 3.05 (rC60xi)MI: 1.7 (rP19x)Ipa.3@MI Max: 776(L38xi)	lspta.3: 420.2 (L38xi)TI Type: TIC (rC60xi)TI Value: 3.05 (rC60xi)MI: 1.7 (rP19x)lpa.3@MI Max: 776(L38xi)	lspta.3: 708.8 (TEEx)TI Type: TIB (L38xi)TI Value: 4.06 (L38xi)MI: 1.51 (P21x)lpa.3@MI Max: 776(L38xi)	lspta.3: 434mW/cm2TI Type: TICTI Value: 1.8MI: 1.1lpa.3@MI Max: 265.4W/cm2
AcousticOutput Display& FDA Limits	Display Feature forHigher OutputsMI Output DisplayTI Output Display	Display Feature forHigher OutputsMI Output DisplayTI Output Display	Display Feature forHigher OutputsMI Output DisplayTI Output Display	Display Feature forHigher OutputsMI Output DisplayTI Output Display
Modes ofOperation	B-mode GrayscaleImagingTissue HarmonicImagingM-modeColor M-ModeColor Power DopplerZoomCombination ModesSonoHD2 NoiseReductionSonoMB/MBe ImageCompoundingVelocity Color Doppler	B-mode GrayscaleImagingTissue HarmonicImagingM-modeColor M-ModeColor Power DopplerZoomCombination ModesSonoHD2 NoiseReductionSonoMB/MBe ImageCompoundingVelocity Color Doppler	B-mode GrayscaleImagingTissue HarmonicImagingM-modeColor M-ModeColor Power DopplerZoomCombination ModesPulsed Wave (PW)DopplerContinuous Wave (CW)DopplerSonoHD2 NoiseReductionSonoMB/MBe ImageCompoundingSteered CW DopplerVelocity Color DopplerTissue Doppler Imaging(TDI)	B-ModePulse InversionHarmonic ImagingCompound HarmonicImagingSpatial CompoundImagingM-modeVelocity Color DopplerColor Power DopplerDirectional Color PowerDopplerPulsed Wave DopplerPulsed Wave TissueDopplerContinuous WaveDoppler, ECG
PW Doppler	Not available	Not available	Available on all imagingtransducers except D2xand P11xAdjustable samplevolume size: 1.0 – 25mmSimultaneous or duplexmode of operationSimultaneous B-modeand PW DopplerHigh PRF capability	Available on all imagingtransducers.SimultaneousDuplexTriplexSimultaneous B-modeand PW DopplerHigh PRF capability
CW Doppler	Not available	Not available	Available on C11x, D2x,P10x, P21x, TEExSimultaneous or duplexmode of operationSimultaneous B-modeand CW Doppler	Available on P21xSimultaneousDuplexTriplexSimultaneous B-modeand CW Doppler
Velocity Color	Available on all	Available on all	Available on all	Available on all
Feature	SonoSite SIIUltrasoundSystem(This submission)	SonoSite SIIUltrasoundSystem(K160734)	SonoSite EdgeUltrasoundSystem(K133454)	FUJIFILM FC1UltrasoundSystem(K160406)
Doppler	transducers	transducers	transducers except D2x	transducers
ECG Feature	Not available	Not available	3-lead ECG input	One 3-lead ECG input,orOne external ECG input,orOne other physio input
DICOM	DICOM 3.0 Store, Print,Modality Worklist,Perform Procedure Step(PPS), StorageCommitment	DICOM 3.0 Store, Print,Modality Worklist,Perform Procedure Step(PPS), StorageCommitment	DICOM 3.0 Store, Print,and Modality Worklist	DICOM 3.0 Store, Print,and Modality Worklistservice class userfeatures
IMTMeasurement	Not available	Not available	SonoCalc IMT providesthe capability forautomated measurementof intima-mediathickness (IMT) of thecarotid artery. IMTfunctionality is availableboth on the ultrasoundsystem and in a standalone software programthat runs on a personalcomputer.	Manual IMTmeasurementfunctionality available.
#TransmitChannels	128 digital channels	128 digital channels	128 digital channels	64 digital channels
#ReceiveChannels	64 digital channels(128 digital channelsusing SyntheticAperture)	64 digital channels(128 digital channelsusing Synthetic Aperture)	64 digital channels(128 digital channelsusing Synthetic Aperture)	64 digital channels
PatientContactMaterials	Transducers:Acrylonitrile-butadien-styrene (ABS)CycoloyPolycarbonatePolysulfone UDELP1700Poly-Vinyl-Chloride(PVC)Silicone RTV AdhesiveSilicone RubberUrethaneNeedle Guides:Acetal copolymerAcrylonitrile-butadien-	Transducers:CycoloyPolycarbonatePolysulfone UDELP1700Poly-Vinyl-Chloride(PVC)Silicone RTV AdhesiveSilicone RubberUrethaneNeedle Guides:Acetal copolymerAcrylonitrile-butadien-	Transducers:Acrylonitrile-butadien-styrene (ABS)CycoloyDow Medical Adhesive,Type AEpoxy paste adhesivePolyethylene (PE)lonomerPolyetheretherketone(PEEK)PolycarbonatePolysulfone UDELP1700PolyurethanePoly-Vinyl-Chloride(PVC)Silicone RTV AdhesiveSilicone RubberUrethaneNeedle Guides:Acetal copolymerAcrylonitrile-butadien-	Transducers:Acrylonitrile-butadien-styrene (ABS)Dow Medical Adhesive,Type AEpoxy paste adhesive,Polysulfone UDELP1700PolyurethanePoly-Vinyl-Chloride(PVC)Silicone RubberUrethaneNeedle Guides:Acetal copolymerAcrylonitrile-butadien-
Feature	SonoSite SIIUltrasoundSystem(This submission)	SonoSite SIIUltrasoundSystem(K160734)	SonoSite EdgeUltrasoundSystem(K133454)	FUJIFILM FC1UltrasoundSystem(K160406)
	styrene (ABS)	styrene (ABS)	styrene (ABS)	styrene (ABS)
Product SafetyCertification	AAMI/ANSI ES60601-1:2005 (R2012)IEC 60601-2-37: 2007CAN/CSA C22.2 No.60601-1:08NEMA UD2-2004IEC 62359:2010	AAMI/ANSI ES60601-1:2005 (R2012)IEC 60601-2-37: 2007CAN/CSA C22.2 No.60601-1:08NEMA UD2-2004IEC 62359:2010	AAMI/ANSI ES60601-1:2005 (R2012)IEC 60601-2-37: 2007CAN/CSA C22.2 No.60601-1:08NEMA UD2-2004AIUM RTD2-2004(NEMA UD3-2004(R2009))	AAMI/ANSI ES60601-1:2005 (R2012)IEC 60601-2-37: 2007CAN/CSA C22.2 No.601.1JIS T 0601-1, JIS T 1507CEI/IEC 61157ANSI/AAMI EC53NEMA UD2-2004AIUM RTD2-2004(NEMA UD3-2004(R2009))
EMCCompliance	AAMI / ANSI / IEC60601-1-2:2007(R)2012CISPR 11, Group 1,Class A	AAMI / ANSI / IEC60601-1-2:2007(R)2012CISPR 11, Group 1,Class A	AAMI / ANSI / IEC60601-1-2:2007(R)2012CISPR 11, Group 1,Class A	IEC 60601-1-2:2007CISPR 11IEC 61000-4 pt 2-5
DICOM	NEMA PS3.15 2003	NEMA PS3.15 2003	NEMA PS3.15 2003	NEMA PS3.15 2003
AirborneEquipmentStandards	RTCA/DO160 (section21)	RTCA/DO160 (section21)	RTCA/DO160 (section21)	None
SystemCharacteristics	SII:Beamformer 128/128using SA (configurable)Hand held display andcontrolSingle 12.1" LiquidCrystal Display (LCD)256 gray shades on LCD	SII:Beamformer 128/128using SA (configurable)Hand held display andcontrolSingle 12.1" LiquidCrystal Display (LCD)256 gray shades on LCD	Edge:Beamformer 128/128using SA (configurable)Hand held display andcontrolSingle 12.1" LiquidCrystal Display (LCD)256 gray shades on LCD	FC1:Beamformer 64/64Hand held display andcontrolSingle 12.1" LiquidCrystal Display (LCD)256 gray shades on LCD
	3 USB ports	3 USB ports	2 USB ports	4 USB ports
	Dimensions: 11.5"(W) x17.6" (L) x 4.8"(H)	Dimensions: 11.5"(W) x17.6" (L) x 4.8"(H)	Dimensions: 12.9"(W) x12.4" (L) x 2.5"(H)	Dimensions: 12.24"(W) x13.03" (L) x 3.03"(H)
	Weight: 12.6 lbs	Weight: 12.6 lbs	Weight: 8.5 lbs	Weight: 11.9 lbs
	System operates viabattery or AC power	System operates viabattery or AC power	System operates viabattery or AC powerBattery life: 1.5 - 4 houroperation per charge	System operates viabattery or AC powerBattery operated (1.5 - 4hour operation percharge)
	100 - 240V options,50/60 Hz, 15VDC output	100 - 240V options,50/60 Hz, 15VDC output	100 - 240V options,50/60 Hz, 15VDC output	100 - 240V options,50/60 Hz, 15VDC output
	Various obstetrical,cardiac, volume, and M-mode measurement andcalculation packages	Various obstetrical,cardiac, volume, and M-mode measurement andcalculation packages	Various obstetrical,cardiac, volume, M-mode, PW and CWDoppler measurementand calculation packages	Various obstetrical,cardiac, volume, M-mode, PW and CWDoppler measurementand calculationpackages
Feature	SonoSite SIIUltrasoundSystem(This submission)	SonoSite SIIUltrasoundSystem(K160734)	SonoSite EdgeUltrasoundSystem(K133454)	FUJIFILM FC1UltrasoundSystem(K160406)
			ECG acquisition anddisplay capabilitiesCW/PW Doppler AudioSpectral Doppler Audioand image storage onremovable media	ECG acquisition anddisplay capabilitiesCW/PW Doppler AudioSpectral Doppler Audioand image storage onremovable media
	Wireless 802.11 supportfor image transfer	Wireless 802.11 supportfor image transfer	Wireless 802.11 (b/g/n)support for imagetransfer	Wireless 802.11 (a\b\g)support for imagetransfer
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 SonoSite Edge II Ultrasound System and SonoSite SII Ultrasound System have been evaluated for electrical, thermal, mechanical, and EMC safety. Additionally, cleaning/disinfection, biocompatibility, and acoustic output have been evaluated, and the device(s) have 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 SonoSite Edge II Ultrasound System and SonoSite SII Ultrasound System are 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	AAMI / ANSI ES60601-1:2005/(R)2012 and C1:2009/(R)2012 and A2:2010/(R)2012(Consolidated Text) Medical electrical equipment - Part 1: General requirements forbasic 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

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Reference No.	Title
NEMA UD 2-2004	Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment

Summary of Clinical Tests:

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

Conclusion: 8)

Intended uses and other key features are consistent with traditional clinical practice and FDA guidance. The SonoSite Edge II Ultrasound System and SonoSite SII Ultrasound 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 SonoSite Edge II Ultrasound System and SonoSite SII Ultrasound System are 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.

Indications for Use

Indications for Use (Describe)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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SonoSite Edge II Ultrasound System:

Additional Comments:

All items marked "P" were previously cleared in 510(k) K153626 (Edge II).

Additional Comments:

Additional Comments:

Additional Comments:

Additional Comments:

Additional Comments:

Additional Comments:

Additional Comments:

Additional Comments:

Additional Comments:

Additional Comments:

Additional Comments:

Additional Comments:

Additional Comments:

All items marked "P" were previously cleared in 510(k) K153626 (Edge II).

Additional Comments:

Indications for Use

Indications for Use (Describe)

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *

SonoSite SII Ultrasound System:

Additional Comments:

All items marked "P" were previously cleared in 510(k) K160734 (SII).

Additional Comments:

Additional Comments:

Additional Comments:

All items marked "P" were previously cleared in 510(k) K160406 (FC1).

Additional Comments:

Additional Comments:

Additional Comments:

Additional Comments:

Additional Comments:

Additional Comments:

Additional Comments:

Additional Comments:

All items marked "P" were previously cleared in 510(k) K160734 (SII).

Additional Comments:

All items marked "P" were previously cleared in 510(k) K160734 (SII).

Additional Comments:

All items marked "P" were previously cleared in 510(k) K160734 (SII).

510(k) Summary

1) Submitter's name, address, telephone number, contact person:

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

Proprietary Name

Classification Names

3) Identification of the predicate or legally marketed device:

4) Device Description:

SONOSITE EDGE II ULTRASOUND SYSTEM:

SONOSITE SII ULTRASOUND SYSTEM

5) Intended Use:

SONOSITE EDGE II ULTRASOUND SYSTEM

SONOSITE SII ULTRASQUND SYSTEM

6) Technological Characteristics:

SONOSITE EDGE II ULTRASOUND SYSTEM:

SONOSITE SII ULTRASOUND SYSTEM

7) Determination of Substantial Equivalence:

Summary of Non-Clinical Tests:

Summary of Clinical Tests:

Conclusion: 8)

§ 892.1550 Ultrasonic pulsed doppler imaging system.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW