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

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

This is an FDA 510(k) premarket notification for the FUJIFILM SonoSite, Inc. SonoSite SII Ultrasound System. The document focuses on establishing substantial equivalence to previously cleared predicate devices, rather than presenting a standalone study with specific acceptance criteria and performance metrics for a novel AI device.

Therefore, the information you're requesting regarding acceptance criteria, study details, sample sizes, expert qualifications, and comparison with human readers is not directly available in this type of regulatory submission for a standard ultrasound system. This document is a clearance for a medical device that does not appear to involve AI/ML components for diagnostic interpretation that would necessitate such detailed performance studies.

However, I can extract information relevant to the device's characteristics and how its substantial equivalence was determined based on what is provided:

1. A table of acceptance criteria and the reported device performance

The document doesn't present a table of specific acceptance criteria in numerical performance metrics typically seen with AI devices (e.g., sensitivity, specificity, AUC). Instead, substantial equivalence is claimed based on similar technological characteristics, intended uses, and compliance with recognized safety and performance standards to the predicate devices.

Here's a summary of the characteristics of the SonoSite SII Ultrasound System as reported in the submission, compared to its predicates (K162045 SonoSite SII Ultrasound System and K162045 SonoSite Edge II Ultrasound System):

Feature	SonoSite SII Ultrasound System (This submission)	SonoSite SII Ultrasound System (K162045 - Predicate)	SonoSite Edge II Ultrasound System (K162045 - Predicate)
Intended Use	Diagnostic ultrasound imaging or fluid flow analysis of the human body	Diagnostic ultrasound imaging or fluid flow analysis of the human body	Diagnostic ultrasound imaging or fluid flow analysis of the human body
Indications for Use (Key Applications)	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, Needle guidance	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, Needle guidance	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, Needle guidance
Transducer Types	Linear Array, Curved Linear Array, Intracavitary, Phased Array	Linear Array, Curved Linear Array, Intracavitary, Phased Array	Linear Array, Curved Linear Array, Intracavitary, Phased Array, Trans-esophageal
Transducer Frequency	1.0 — 15.0 MHz	1.0 – 15.0 MHz	1.0 – 15.0 MHz
Global Maximum Outputs/Worst Case Setting	Ispta.3: 598.9 (HFL50x), TI Type: TIB (rP19x), TI Value: 4.98 (rP19x), MI: 1.7 (rP19x), Ipa.3@MI Max: 776 (L38xi)	Ispta.3: 420.2 (L38xi), TI Type: TIC (rC60xi), TI Value: 3.05 (rC60xi), MI: 1.7 (rP19x), Ipa.3@MI Max: 776 (L38xi)	Ispta.3: 598.9 (HFL50x), TI Type: TIB (rP19x), TI Value: 4.98 (rP19x), MI: 1.7 (rP19x), Ipa.3@MI Max: 776 (L38xi)
Modes of Operation (Key differences)	Includes PW Doppler (available on all except P11x), CW Doppler (available on P10x and rP19x), Tissue Doppler Imaging (TDI)	No PW or CW Doppler listed for K162045 SII. Modes listed: B-mode Grayscale, THI, M-mode, Color M-Mode, Color Power Doppler, Zoom, Combination Modes, SonoHD2 Noise Reduction, SonoMB/MBe, Compounding, Velocity Color Doppler.	Includes PW and CW Doppler, Tissue Doppler Imaging (TDI)
ECG Feature	3-lead ECG input, or ECG Slave Cable	Not available	3-lead ECG input, or ECG Slave Cable
DICOM Version	DICOM 3.0 Store, Print, Modality Worklist, Perform Procedure Step (PPS), Storage Commitment (NEMA PS3.15 2011)	DICOM 3.0 Store, Print, Modality Worklist, Perform Procedure Step (PPS), Storage Commitment (NEMA PS3.15 2003)	DICOM 3.0 Store, Print, Modality Worklist, Perform Procedure Step (PPS), Storage Commitment (NEMA PS3.15 2011)
Product Safety Certification	AAMI/ANSI ES60601-1:2005 (R2012), IEC 60601-2-37 Ed. 2.1:2015, CAN/CSA C22.2 No. 60601-1:08, NEMA UD2-2004, IEC 62359 (2017 - although form states 2015 for 60601-2-37 and 2017 for 62359 in standard listing)	AAMI/ANSI ES60601-1:2005 (R2012), IEC 60601-2-37: 2007, CAN/CSA C22.2 No. 60601-1:08, NEMA UD2-2004, IEC 62359:2010	AAMI/ANSI ES60601-1:2005 (R2012), IEC 60601-2-37 Ed. 2.1 :2015, CAN/CSA C22.2 No. 60601-1:08, NEMA UD2-2004, IEC 62359:2017

Acceptance Criteria for Substantial Equivalence (General, inferred from 510(k) process):

Identical Intended Use: The device must have the same intended use as a legally marketed predicate device.
Similar Technological Characteristics: The device must have similar technological characteristics to the predicate, or if there are differences, these differences must not raise new questions of safety or effectiveness.
Equivalent Safety and Effectiveness: The device must be as safe and effective as the predicate device. This is often demonstrated through adherence to recognized standards for electrical, thermal, mechanical, EMC safety, cleaning/disinfection, biocompatibility, and acoustic output.
Compliance with Standards: Conformance to relevant national and international medical device safety and performance standards (e.g., ISO, IEC, NEMA UD).

Reported Performance (Relevant to ultrasound system functionality, not AI-specific):

The performance of the device is assessed against the established standards and its predicate's performance. The submission states: "The 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."
New "N" indications for specific transducers (found in Tables 1.3-1 to 1.3-14) for Pulsed Wave Doppler (PWD), and in some cases, Color Doppler modes show the scope of the device's capabilities are being expanded or specifically detailed for certain transducers.

2. Sample size used for the test set and the data provenance:

The document explicitly states: "The SonoSite SII Ultrasound System, subject of this submission, did not require clinical studies to support the determination of substantial equivalence."
Therefore, there is no test set sample size or data provenance related to clinical performance metrics for this device as it is not an AI/ML device requiring such validation for regulatory clearance. The assessment is based on technical, safety, and performance characteristic comparison.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable, as no clinical study or test set with ground truth established by experts was conducted or required for this 510(k) submission.

4. Adjudication method for the test set:

Not applicable, as no clinical study or test set requiring adjudication was conducted or required for this 510(k) submission.

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, as this device is a general-purpose ultrasound system and does not appear to incorporate AI assistance for diagnostic interpretation. Hence, no MRMC study or AI assistance effect size is mentioned.

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

Not applicable, as this is a medical imaging device as opposed to an AI algorithm.

7. The type of ground truth used:

Not applicable, as no clinical study requiring ground truth for clinical decision or diagnostic performance was conducted. The "ground truth" in this context refers to compliance with performance and safety standards, and equivalence to predicate devices, rather than diagnostic accuracy.

8. The sample size for the training set:

Not applicable, as this is a traditional ultrasound system and not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established:
Not applicable, for the same reason as above.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue. Underneath the FDA logo is the word "ADMINISTRATION" in blue.

February 7, 2019

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

Re: K183235

Trade/Device Name: SonoSite SII 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: January 30, 2019 Received: February 4, 2019

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-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,

Hse 2. Nils

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) K183235

Device Name SonoSite SII Ultrasound System

Indications for Use (Describe)

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 thuid 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

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

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SonoSite SII Ultrasound System:

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

Table 1.3-1: 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	N		P	B+M; B+PWD;B+CD	1-5
Fetal	P	P	N		P	B+M; B+PWD; B+CD	1-5
Abdominal	P	P	N		P	B+M; B+PWD; B+CD	1-5
Intra-operative (Abdominalorgans and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P	N		P	B+M; B+PWD;B+CD	1-5
Small Organ (breast, thyroid,testicles, prostate)	P	P	N		P	B+M; B+PWD; B+CD	1-5
Neonatal Cephalic	P	P	N		P	B+M; B+PWD; B+CD	1-3,5
Adult Cephalic	P	P	N		P	B+M; B+PWD; B+CD	1-3,5
Trans-rectal	P	P	N		P	B+M; B+PWD; B+CD	1,5
Trans-vaginal	P	P	N		P	B+M; B+PWD; B+CD	1,5
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)	P	P	N		P	B+M; B+PWD; B+CD	1,2,4,5
Musculo-skel. (Superfic.)	P	P	N		P	B+M; B+PWD; B+CD	1,4,5
Intra-luminal
Other (spec.)
Cardiac Adult	P	P	N	N	P	B+M; B+PWD; B+CWD;B+CD	1-5
Cardiac Pediatric	P	P	N	N	P	B+M; B+PWD;B+CWD;B+CD	1-5
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	P	P	N		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 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) K162045 and K160734

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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	N		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 – C8x/8-5 MHz 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) K160734 (SII).

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Table 1.3-3: 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
	B	M	PWD	CWD	Color Doppler	Combined (Spec.)	Other (Spec.)
Ophthalmic
Fetal
Abdominal	P	P	N		P	B+M; B+PWD; B+CD	1,5
Intra-operative (Abdominal organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P	N		P	B+M; B+PWD; B+CD	1,5
Small Organ (breast, thyroid, testicles, prostate)
Neonatal Cephalic	P	P	N		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	N		P	B+M; B+PWD; B+CD	1,5
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	P	P	N		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:

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).

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Table 1.3-4: 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	B	M	PWD	CWD	ColorDoppler	Combined(Spec.)	Other(Spec.)
Ophthalmic
Fetal	P	P	N		P	B+M; B+PWD; B+CD	1,4,5
Abdominal	P	P	N		P	B+M; B+PWD; B+CD	1,4,5
Intra-operative (Abdominalorgans and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P	N		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	N		P	B+M; B+PWD;B+CD	1,4,5
Musculo-skel. (Superfic.)	P	P	N		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	N		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) K160734 (SII).

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Table 1.3-5: 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 human body as follows:
Clinical Application	Mode of Operation						Other(Spec.)
	B	M	PWD	CWD	ColorDoppler	Combined(Spec.)
Ophthalmic	P				P
Fetal	P	P	N		P	B+M; B+PWD; B+CD	1,2,4,5
Abdominal	P	P	N		P	B+M; B+PWD; B+CD	1,2,4,5
Intra-operative (Abdominal organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P	N		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	N		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	N		P	B+M; B+PWD; B+CD	1,2,4,5

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).

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Table 1.3-6: 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 human
		body as follows:
Clinical Application		Mode of Operation
						Combined(Spec.)	Other(Spec.)
	B	M	PWD	CWD	ColorDoppler
Ophthalmic	P	P	N		P	B+M; B+PWD; B+CD	1,4,5
Fetal
Abdominal	P	P	N		P	B+M; B+PWD; B+CD	1,4,5
Intra-operative (Abdominalorgans and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P	N		P	B+M; B+PWD; B+CD	1,4,5
Small Organ (breast, thyroid,testicles, prostate)	P	P	N		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	N		P	B+M; B+PWD; B+CD	1,4,5
Musculo-skel. (Superfic.)	P	P	N		P	B+M; B+PWD; B+CD	1,4,5
Intra-luminal
Other (spec.)
Cardiac Adult	P	P	N		P	B+M; B+PWD; B+CD	1,4,5
Cardiac Pediatric	P	P	N		P	B+M; B+PWD; B+CD	1,4,5
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	P	P	N		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) K160734 & K162045.

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Table 1.3-7: 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 human
		body as follows:
Clinical Application		Mode of Operation

	B	M	PWD	CWD	ColorDoppler	Combined(Spec.)	Other(Spec.)
Ophthalmic
Fetal
Abdominal	P	P	N		P	B+M; B+PWD; B+CD	1,4,5
Intra-operative (Abdominalorgans and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P	N		P	B+M; B+PWD; B+CD	1,4,5
Small Organ (breast, thyroid,testicles, prostate)	P	P	N		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	N		P	B+M; B+PWD; B+CD	1,4,5
Musculo-skel. (Superfic.)	P	P	N		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	N		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) K160734 (SII).

{10}------------------------------------------------

Table 1.3-8: 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	B	M	PWD	CWD	ColorDoppler	Combined(Spec.)	Other(Spec.)
Ophthalmic	P	P	N		P	B+M; B+PWD; B+CD	1,4,5
Fetal	P	P	N		P	B+M; B+PWD; B+CD	1,4,5
Abdominal	P	P	N		P	B+M; B+PWD; B+CD	1,4,5
Intra-operative (Abdominalorgans and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P	N		P	B+M; B+PWD; B+CD	1,4,5
Small Organ (breast, thyroid,testicles, prostate)	P	P	N		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	N		P	B+M; B+PWD; B+CD	1,4,5
Musculo-skel. (Superfic.)	P	P	N		P	B+M; B+PWD; B+CD	1,4,5
Intra-luminal
Other (spec.)
Cardiac Adult	P	P	N		P	B+M; B+PWD; B+CD	1,4,5
Cardiac Pediatric	P	P	N		P	B+M; B+PWD; B+CD	1,4,5
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	P	P	N		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) K160734 (SII).

{11}------------------------------------------------

Table 1.3-9: 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		Mode of Operation
	B	M	PWD	CWD	ColorDoppler	Combined(Spec.)	Other(Spec.)
Ophthalmic
Fetal	P	P	N		P	B+M; B+PWD; B+CD	1,5
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	P	P	N		P	B+M; B+PWD; 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).

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

Table 1.3-10: 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	Mode of Operation
	B	M	PWD	CWD	ColorDoppler	Combined(Spec.)	Other(Spec.)
Ophthalmic	P	P	N		P	B+M; B+PWD; B+CD	1,4,5
Fetal
Abdominal	P	P	N		P	B+M; B+PWD; B+CD	1,4,5
Intra-operative (Abdominalorgans and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P	N		P	B+M; B+PWD; B+CD	1,4,5
Small Organ (breast, thyroid,testicles, prostate)	P	P	N		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	N		P	B+M; B+PWD; B+CD	1,4,5
Musculo-skel. (Superfic.)	P	P	N		P	B+M; B+PWD;B+CD	1,4,5
Intra-luminal
Other (spec.)
Cardiac Adult	P	P	N		P	B+M; B+PWD; B+CD	1,4,5
Cardiac Pediatric	P	P	N		P	B+M; B+PWD; B+CD	1,4,5
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	P	P	N		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) K160734 (SII).

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

Table 1.3-11: 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 humanbody as follows:
Clinical Application	Mode of Operation
	B	M	PWD	CWD	ColorDoppler	Combined(Spec.)	Other(Spec.)
Ophthalmic
Fetal
Abdominal	P	P	N		P	B+M; B+PWD; B+CD	1,4,5
Intra-operative (Abdominalorgans and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P	N		P	B+M; B+PWD; B+CD	1,4,5
Small Organ (breast, thyroid,testicles, prostate)	P	P	N		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	N		P	B+M; B+PWD; B+CD	1,4,5
Cardiac Pediatric	P	P	N		P	B+M; B+PWD;B+CD	1,4,5
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	P	P	N		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) K160734 (SII).

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

Table 1.3-12: 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	N		P	B+M; B+PWD; B+CD	1,5
Fetal	P	P	N		P	B+M; B+PWD; B+CD	1,5
Abdominal	P	P	N		P	B+M; B+PWD; B+CD	1,5
Intra-operative (Abdominalorgans and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P	N		P	B+M; B+PWD; B+CD	1,5
Small Organ (breast, thyroid,testicles, prostate)	P	P	N		P	B+M; B+PWD; B+CD	1,5
Neonatal Cephalic	P	P	N		P	B+M; B+PWD; B+CD	1,5
Adult Cephalic	P	P	N		P	B+M; B+PWD; B+CD	1,5
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)	P	P	N		P	B+M; B+PWD; B+CD	1,5
Musculo-skel. (Superfic.)
Intra-luminal
Other (spec.)
Cardiac Adult	P	P	N	N	P	B+M;B+PWD; B+CWD; B+CD	1,3,5
Cardiac Pediatric	P	P	N	N	P	B+M; B+PWD; B+CWD; B+CD	1,3,5
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	P	P	N		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:

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).

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

Table 1.3-13: 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).

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

Table 1.3-14: 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 body as follows:
Clinical Application	Mode of Operation
	B	M	PWD	CWD	ColorDoppler	Combined(Spec.)	Other(Spec.)
Ophthalmic	P	P	N		P	B+M; B+PWD; B+CD	1-3
Fetal	P	P	N		P	B+M; B+PWD; B+CD	1-3
Abdominal	P	P	N		P	B+M; B+PWD; B+CD	1-3
Intra-operative (Abdominalorgans and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P	N		P	B+M; B+PWD;B+CD	1-3
Small Organ (breast, thyroid,testicles, prostate)	P	P	N		P	B+M; B+PWD; B+CD	1-3
Neonatal Cephalic	N	N	N		N	B+M; B+PWD; B+CD	1-3
Adult Cephalic	N	N	N		N	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	N	N	P	B+M; B+PWD; B+CWD;B+CD	1-3
Cardiac Pediatric	P	P	N	N	P	B+M; B+PWD; B+CWD; B+CD	1-3
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	P	P	N		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 (SonoMB) in B-Mode

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

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

510(k) Summary

K183235

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:	Aditi Chaubal
	Regulatory Affairs Specialist
E-mail:	aditi.chaubal@fujifilm.com
Telephone:	(425) 951-1432
Facsimile:	(425) 951-1201
Date prepared:	September 26, 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 SII 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:

SonoSite Edge II Ultrasound System	K162045
SonoSite SII Ultrasound System	K162045

4) Device Description:

SONOSITE SII ULTRASOUND SYSTEM

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

5) Intended Use:

SONOSITE SII 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 Peripheral Vessel

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

6) Technological Characteristics:

SONOSITE SII ULTRASOUND SYSTEM

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

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

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

7) Determination of Substantial Equivalence:

Summary of Non-Clinical Tests:

The SonoSite SII 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(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 SII Ultrasound System is designed to comply with the following FDA recognized

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

standards.

Reference No.	Title
ISO 10993-1	AAMI / ANSI / ISO 10993-1:2009/(R)2013, Biological evaluation of medicaldevices - 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:General requirements for basic safety and essential performance (IEC60601-1:2005, 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 -Collateral standard: 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:General requirements for basic safety and essential performance - Collateralstandard: Usability
IEC 60601-2-37	IEC 60601-2-37 Edition 2.1 2015, Medical electrical equipment - Part 2-37:Particular requirements for the basic safety and essential performance ofultrasonic medical diagnostic and monitoring equipment
IEC 62304	AAMI / ANSI / IEC 62304:2006+A1:2015, Medical device software - Softwarelife cycle processes
IEC 62359	IEC 62359 Edition 2.1 2017-09 CONSOLIDATED VERISON, Ultrasonics –Field characterization – Test methods for the determination of thermal andmechanical indices related to medical diagnostic ultrasonic fields
ISO 14971	ISO 14971:2007, Medical devices - Application of risk management tomedical devices
NEMA UD 2-2004(R2009)	Acoustic Output Measurement Standard for Diagnostic UltrasoundEquipment Revision 3

Summary of Clinical Tests:

The SonoSite SII Ultrasound System, 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 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 SII 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.

Feature	SonoSite SIIUltrasound System(This submission)	SonoSite SII UltrasoundSystem(K162045)	SonoSite Edge IIUltrasound System(K162045)
Intended Use	Diagnostic ultrasound imagingor fluid flow analysis of thehuman body	Diagnostic ultrasound imaging orfluid flow analysis of the humanbody	Diagnostic ultrasound imaging orfluid flow analysis of the humanbody
Indications forUse	OpthalmicFetal - OB/GYNAbdominal	OpthalmicFetal - OB/GYNAbdominal	OpthalmicFetal - OB/GYNAbdominal
	PediatricSmall Organ (breast, thyroid,testicle, prostate)	PediatricSmall Organ (breast, thyroid,testicle, prostate)	PediatricSmall Organ (breast, thyroid,testicle, prostate)
	Neonatal CephalicAdult CephalicTrans-RectalTrans-VaginalMusculo-skeletal(Conventional)Musculo-skeletal (Superficial)Cardiac AdultCardiac Pediatric	Neonatal CephalicAdult CephalicTrans-RectalTrans-VaginalMusculo-skeletal (Conventional)Musculo-skeletal (Superficial)Cardiac AdultCardiac Pediatric	Neonatal CephalicAdult CephalicTrans-RectalTrans-VaginalMusculo-skeletal (Conventional)Musculo-skeletal (Superficial)Cardiac AdultCardiac PediatricTrans-esophageal (cardiac)
	Peripheral VesselNeedle guidance	Peripheral VesselNeedle guidance	Peripheral VesselNeedle guidance
TransducerTypes	Linear ArrayCurved Linear ArrayIntracavitaryPhased Array	Linear ArrayCurved Linear ArrayIntracavitaryPhased Array	Linear ArrayCurved Linear ArrayIntracavitaryPhased ArrayTrans-esophageal
TransducerFrequency	1.0 — 15.0 MHz	1.0 - 15.0 MHz	1.0 - 15.0 MHz
GlobalMaximumOutputs/WorstCase Setting	Ispta.3: 598.9 (HFL50x)TI Type: TIB (rP19x)TI Value: 4.98 (rP19x)MI: 1.7 (rP19x)lpa.3@MI Max: 776 (L38xi)	Ispta.3: 420.2 (L38xi)TI Type: TIC (rC60xi)TI Value: 3.05 (rC60xi)MI: 1.7 (rP19x)Ipa.3@MI Max: 776 (L38xi)	Ispta.3: 598.9 (HFL50x)TI Type: TIB (rP19x)TI Value: 4.98 (rP19x)MI: 1.7 (rP19x)lpa.3@MI Max: 776 (L38xi)
AcousticOutput Display& FDA Limits	Display Feature for HigherOutputsMI Output DisplayTI Output Display	Display Feature for HigherOutputsMI Output DisplayTI Output Display	Display Feature for HigherOutputsMI Output DisplayTI Output Display
Modes ofOperation	B-mode Grayscale ImagingTissue Harmonic ImagingM-modeColor M-Mode	B-mode Grayscale ImagingTissue Harmonic ImagingM-modeColor M-ModeColor Power Doppler	B-mode Grayscale ImagingTissue Harmonic ImagingM-modeColor M-Mode
	Color Power DopplerZoomCombination ModesPulsed Wave (PW) DopplerContinuous Wave (CW)DopplerSonoHD2 Noise ReductionSonoMB/MBe Image	ZoomCombination ModesSonoHD2 Noise ReductionSonoMB/MBe ImageCompounding	Color Power DopplerZoomCombination ModesPulsed Wave (PW) DopplerContinuous Wave (CW) DopplerSonoHD2 Noise ReductionSonoMB/MBe ImageCompounding
Feature	SonoSite SIIUltrasound System(This submission)	SonoSite SII UltrasoundSystem(K162045)	SonoSite Edge IIUltrasound System(K162045)
	CompoundingSteered CW DopplerVelocity Color DopplerTissue Doppler Imaging (TDI)	Velocity Color Doppler	Steered CW DopplerVelocity Color DopplerTissue Doppler Imaging (TDI)
PW Doppler	Available on all imagingtransducers except P11xAdjustable sample volumesize: 1.0 – 25 mmSimultaneous or duplex modeof operationSimultaneous B-mode andPW DopplerHigh PRF capability	Not available	Available on all imagingtransducers except P11xAdjustable sample volume size:1.0 – 25 mmSimultaneous or duplex mode ofoperationSimultaneous B-mode and PWDopplerHigh PRF capability
CW Doppler	Available on P10x and rP19xSimultaneous or duplex modeof operationSimultaneous B-mode andCW Doppler	Not available	Available on P10x, rP19x, TEExiSimultaneous or duplex mode ofoperationSimultaneous B-mode and CWDoppler
Velocity ColorDoppler	Available on all transducers	Available on all transducers	Available on all transducers
ECG Feature	3-lead ECG input, orECG Slave Cable	Not available	3-lead ECG input, orECG Slave Cable
DICOM	DICOM 3.0 Store, Print,Modality Worklist, PerformProcedure Step (PPS),Storage Commitment	DICOM 3.0 Store, Print, ModalityWorklist, Perform Procedure Step(PPS), Storage Commitment	DICOM 3.0 Store, Print, ModalityWorklist, Perform Procedure Step(PPS), Storage Commitment
IMTMeasurement	Not available	Not available	Not available
#TransmitChannels	128 digital channels	128 digital channels	128 digital channels
#ReceiveChannels	64 digital channels(128 digital channels usingSynthetic Aperture)	64 digital channels(128 digital channels usingSynthetic Aperture)	64 digital channels(128 digital channels usingSynthetic Aperture)
Patient ContactMaterials	Transducers:Acrylonitrile-butadien-styrene(ABS)CycoloyEpoxy paste adhesivePolyethylene (PE) IonomerPolyetheretherketone (PEEK)Polycarbonate	Transducers:Acrylonitrile-butadien-styrene(ABS)CycoloyEpoxy paste adhesivePolyethylene (PE) IonomerPolyetheretherketone (PEEK)Polycarbonate	Transducers:Acrylonitrile-butadien-styrene(ABS)CycoloyEpoxy paste adhesivePolyethylene (PE) IonomerPolyetheretherketone (PEEK)Polycarbonate
	Polysulfone UDEL P1700PolyurethanePoly-Vinyl-Chloride (PVC)Silicone RTV AdhesiveSilicone RubberUrethaneNeedle Guides:Acetal copolymerAcrylonitrile-butadien-styrene(ABS)	Polysulfone UDEL P1700PolyurethanePoly-Vinyl-Chloride (PVC)Silicone RTV AdhesiveSilicone RubberUrethaneNeedle Guides:Acetal copolymerAcrylonitrile-butadien-styrene(ABS)	Polysulfone UDEL P1700PolyurethanePoly-Vinyl-Chloride (PVC)Silicone RTV AdhesiveSilicone RubberUrethaneNeedle Guides:Acetal copolymerAcrylonitrile-butadien-styrene(ABS)
Product SafetyCertification	AAMI/ANSI ES60601-1:2005(R2012)IEC 60601-2-37 Ed. 2.1:2015CAN/CSA C22.2 No. 60601-1:08NEMA UD2-2004	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 Ed. 2.1 :2015CAN/CSA C22.2 No. 60601-1:08NEMA UD2-2004IEC 62359:2017
Feature	SonoSite SIIUltrasound System(This submission)	SonoSite SII UltrasoundSystem(K162045)	SonoSite Edge IIUltrasound System(K162045)
EMCCompliance	AAMI / ANSI / IEC 60601-1-2:2007(R)2012CISPR 11, Group 1, Class A	AAMI / ANSI / IEC 60601-1-2:2007(R)2012CISPR 11, Group 1, Class A	AAMI / ANSI / IEC 60601-1-2:2007(R)2012CISPR 11, Group 1, Class A
DICOM	NEMA PS3.15 2011	NEMA PS3.15 2003	NEMA PS3.15 2011
AirborneEquipmentStandards	RTCA/DO160 (section 21)	RTCA/DO160 (section 21)	RTCA/DO160 (section 21)
SystemCharacteristics	SII:Beamformer 128/128 usingSA (configurable)Hand held display and controlSingle 12.1" Liquid CrystalDisplay (LCD)256 gray shades on LCD3 USB portsDimensions: 11.5"(W) x 17.6"(L) x 4.8"(H)Weight: 12.6 lbsSystem operates via battery orAC power	SII:Beamformer 128/128 using SA(configurable)Hand held display and controlSingle 12.1" Liquid CrystalDisplay (LCD)256 gray shades on LCD3 USB portsDimensions: 11.5"(W) x 17.6" (L)x 4.8"(H)Weight: 12.6 lbsSystem operates via battery orAC power	Edge II:Beamformer 128/128 using SA(configurable)Hand held display and controlSingle 12.1" Liquid CrystalDisplay (LCD)256 gray shades on LCD2 USB portsDimensions: 12.8"(W) x 12.1" (L)x 2.5"(H)Weight: 9.0 lbsSystem operates via battery orAC powerBattery life: 1.5 - 4 hour operationper charge
	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-modemeasurement and calculationpackages	Various obstetrical, cardiac,volume, and M-modemeasurement and calculationpackages	Various obstetrical, cardiac,volume, M-mode, PW and CWDoppler measurement andcalculation packages
			ECG acquisition and displaycapabilitiesCW/PW Doppler AudioSpectral Doppler Audio andimage storage on removablemedia
	Wireless 802.11 support forimage transfer	Wireless 802.11 support forimage transfer	Wireless 802.11 (b/g/n) supportfor image transfer
510(k) Track	Track 3	Track 3	Track 3