The SonoSite X-Porte Ultrasound System is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging of thid flow analysis of the human body. Specific clinical applications and exam types include:

Ophthalmic Fetal – OB/GYN Abdominal Pediatric Small Organ (breast, thyroid, testicles, prostate) Neonatal Cephalic Adult Cephalic Trans-vaginal Musculo-skel. (Convent.) Musculo-skel. (Superfic.) Cardiac Adult Cardiac Pediatric Trans-esophageal (card.) Peripheral Vessel

Device Description

The SonoSite X-Porte Ultrasound System is a highly mobile, full featured, general purpostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. X-Porte is a custom fabricated digital electronic design that readily lends itself to be configured for specific ultrasound imaging applications through different system feature selections. The system interface can be customized for the user and controlled using a backlit touchscreen much like what is used in consumer tablet products. X-Porte can be operated in two different configurations, standbased with AC power or battery, and desktop-based with AC power only. In desktop configuration the ultrasound engine can be removed from the stand and used by itself with a single transducer and external monitor.

AI/ML Overview

The provided documentation is a 510(k) Premarket Notification for the FUJIFILM SonoSite, Inc. SonoSite X-Porte Ultrasound System. This document focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than establishing performance criteria through novel clinical studies. Therefore, much of the requested information regarding algorithm performance, sample sizes for test/training sets, expert qualifications, and MRMC studies is not present.

However, based on the provided text, we can extract details regarding the general acceptance criteria (primarily safety and compliance with standards) and the "study" (non-clinical tests and comparisons to predicates) used to demonstrate adherence to these criteria.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily conformance to various medical device safety and performance standards. The "reported device performance" is implicitly that the device meets these standards, enabling a substantial equivalence determination.

Acceptance Criteria (Standards Adherence)	Reported Device Performance
Product Safety Certification:	Conforms to specified standards
AAMI/ANSI ES60601-1:2005 (R2012)
IEC 60601-2-37: 2007
CAN/CSA C22.2 No. 601.1
JIS T 0601-1, JIS T 1507
CEI/IEC 61157
ANSI/AAMI EC53
NEMA UD2-2004
IEC 62359:2010
Biocompatibility ISO 10993-1:2009/(R)2013	All patient contact materials are biocompatible (implicit)
Risk Management ISO 14971: 2007	Employed in product development (implicit)
Electrical, thermal, mechanical safety evaluation	Evaluated (implicit)
Acoustic Output Measurement Standard (NEMA UD 2-2004)	Conforms, specific maximum outputs provided
EMC Compliance:	Conforms to specified standards
IEC 60601-1-2:2007
CISPR 11
IEC 61000-4 pt 2-5
DIOCOM Compliance:	Conforms to specified standard
NEMA PS3.15:2011
Airborne Equipment Standards:	Conforms to specified standard
RTCA/DO160D (section 21)
Indications for Use: (e.g., Ophthalmic, Fetal, Abdominal, etc., across various modes for the system and for each transducer type)	Device is intended for these specific clinical applications and exam types
Technological Characteristics: (e.g., Transducer Types, Frequency, Maximum Outputs, Modes of Operation, PW/CW Doppler features, ECG, DICOM, Channels, Patient Contact Materials, System Characteristics)	The new device has comparable technological characteristics to predicate devices

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

Test Set Sample Size: Not applicable in the context of this 510(k) submission. The submission relies on non-clinical testing and comparison to predicates, not a clinical test set for AI performance.
Data Provenance: Not applicable for performance evaluation in the usual sense. The "data" here refers to measurements and tests conducted to ensure compliance with standards, and these are typically internal engineering tests. The document states "Clinical Validation" was part of product development, but no details are provided about this "validation" with respect to a test set.

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

Not applicable. "Ground truth" in the clinical performance sense (e.g., expert consensus on diagnoses) is not described or required for this type of 510(k) submission focused on substantial equivalence of an ultrasound system, not an algorithmic diagnostic device. The "truth" is established by adherence to engineering and safety standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. There is no mention of an adjudication method as no clinical test set for diagnostic accuracy is described.

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

Not applicable. This is a submission for an ultrasound imaging system, not an AI-assisted diagnostic algorithm. There is no MRMC study mentioned or required for this type of device.

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

Not applicable. This is not an algorithmic diagnostic device, but rather a general-purpose ultrasound system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" or basis for the acceptance of this device primarily stems from:

Engineering and safety standards compliance (e.g., IEC 60601-1, NEMA UD2-2004 for acoustic output).
Biocompatibility testing for patient contact materials.
Risk assessment outcomes.
Comparison of technological characteristics and intended uses to previously cleared predicate devices (K152209, K133454, K162045).

8. The sample size for the training set

Not applicable. This document describes an ultrasound hardware system, not an AI/algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as no training set for an algorithm is described.

Summary

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

June 12, 2017

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

Re: K171437

Trade/Device Name: SonoSite X-Porte Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: May 12, 2017 Received: May 16, 2017

Dear Mr. Mark 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/ResourcesforYou/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. O'Hara
For

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

Enclosure

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Indications for Use

510(k) Number (if known) K171437

Device Name SonoSite X-Porte Ultrasound System

Indications for Use (Describe)

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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Table 1.3-1: Diagnostic Ultrasound Indications for Use Form – SonoSite X-Porte Ultrasound System

System:	SonoSite X-Porte Ultrasound System
Transducer:	N/A
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the humanbody as follows:
Clinical Application	Mode of Operation
	B	M	PWD	CWD	ColorDoppler(C)	Combined(Spec.)	Other(Spec.)
Ophthalmic	P	P	P		P	B+M; B+PWD; B+C;(B+C)+PWD	1-5
Fetal	P	P	P		P	B+M; B+PWD; B+C;(B+C)+PWD	1,2,5
Abdominal	P	P	P	P	P	B+M; B+PWD; B+CWD;B+C; (B+C)+PWD;(B+C)+CWD	1,2,5
Intra-operative (Abdominalorgans and vascular)
Intra-operative (Neuro.)
LaparoscopicPediatric	P	P	P		P	B+M; B+PWD; B+CWD;B+C; (B+C)+PWD;(B+C)+CWD	1-5
Small Organ (breast, thyroid,testicles, prostate)	P	P	P		P	B+M; B+PWD; B+C;(B+C)+PWD	1,4,5
Neonatal Cephalic	P	P	P		P	B+M; B+PWD; B+C;(B+C)+PWD	1,5
Adult Cephalic	P	P	P		P	B+M; B+PWD; B+C;(B+C)+PWD	1,5
Trans-rectal
Trans-vaginal	P	P	P		P	B+M; B+PWD; B+C;(B+C)+PWD	1,5
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)	P	P	P		P	B+M; B+PWD; B+C;(B+C)+PWD	1,2,4,5
Musculo-skel. (Superfic.)	P	P	P		P	B+M; B+PWD; B+C;(B+C)+PWD	1,4,5
Intra-luminal
Other (spec.)
Cardiac Adult	P	P	P	P	P	B+M; B+PWD; B+CWD;B+C; (B+C)+PWD;(B+C)+CWD	1-3
Cardiac Pediatric	P	P	P	P	P	B+M; B+PWD; B+CWD;B+C; (B+C)+PWD;(B+C)+CWD	1-3
Trans-esophageal (card.)	P	P	P	P	P	B+M; B+PWD; B+CWD;B+C; (B+C)+PWD;(B+C)+CWD	1,3
Other (spec.)
Peripheral vessel	P	P	P		P	B+M; B+PWD; B+C;B+C; (B+C)+PWD	1,2,4-6
Other (spec.)

Additional Comments:

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

6: B+PWD and (B+C)+PWD includes Simultaneous PW

All items marked "P" were previously cleared in 510(k) K152209, K142017, K133134. Prescription Use (Per 21 CFR 801.109)

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System:	SonoSite X-Porte Ultrasound System
Transducer:	C11xp/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	ColorDoppler(C)	Combined(Spec.)	Other(Spec.)
Ophthalmic
Fetal	P	P	P		P	B+M; B+PWD; B+C;(B+C)+PWD	1,5
Abdominal	P	P	P		P	B+M; B+PWD; B+C;(B+C)+PWD	1,5
Intra-operative (Abdominalorgans and vascular)
Intra-operative (Neuro.)
Laparoscopic	P	P	P		P	B+M; B+PWD; B+C;(B+C)+PWD	1,5
Pediatric
Small Organ (breast, thyroid,testicles. prostate)	P	P	P		P	B+M; B+PWD; B+C;(B+C)+PWD	1,5
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+C;(B+C)+PWD	1,5
Cardiac Pediatric
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	P	P	P		P	B+M; B+PWD; B+C;(B+C)+PWD	1,5
Other (spec.)

Table 1.3-2: Diagnostic Ultrasound Indications for Use Form – C11xp/8-5 MHz Transducer

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 Simultaneous 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

6: B+PWD and (B+C)+PWD includes Simultaneous PW

All items marked "P" were previously cleared in 510(k) K142017.

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System:	SonoSite X-Porte Ultrasound System
Transducer:	C35xp/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(C)	Combined(Spec.)	Other(Spec.)
Ophthalmic
Fetal
Abdominal	P	P	P		P	B+M; B+PWD; B+C;(B+C)+PWD	1,2,5
Intra-operative (Abdominalorgans and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P	P		P	B+M; B+PWD; B+C;(B+C)+PWD	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+C;(B+C)+PWD	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+C;(B+C)+PWD	1,2,4,5
Other (spec.)

Table 1.3-3: Diagnostic Ultrasound Indications for Use Form – C35xp/8-3 MHz Transducer

Additional Comments:

1: Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures and imaging quidance for peripheral nerve block procedures. Color Doppler includes Power/Velocity/Variance. M-Mode includes Simultaneous 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
6: B+PWD and (B+C)+PWD includes Simultaneous PW

All items marked "P" were previously cleared in 510(k) K142017.

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System:	SonoSite X-Porte Ultrasound System
Transducer:	C60xp/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(C)	Combined(Spec.)	Other(Spec.)
Ophthalmic	P	P	P	P	P	B+M; B+PWD; B+C;(B+C)+PWD	1,2,5
Fetal	P	P	P	P	P	B+M; B+PWD; B+C;(B+C)+PWD	1,2,5
Abdominal
Intra-operative (Abdominalorgans and vascular)
Intra-operative (Neuro.)
Laparoscopic	P	P	P	P	P	B+M; B+PWD; B+C;(B+C)+PWD	1,2,4,5
Pediatric
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	P	B+M; B+PWD; B+C;(B+C)+PWD	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	P	B+M; B+PWD; B+C;(B+C)+PWD	1,2,4,5
Other (spec.)

Table 1.3-4: Diagnostic Ultrasound Indications for Use Form – C60xp/5-2 MHz Transducer

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

6: B+PWD and (B+C)+PWD includes Simultaneous PW

All items marked "P" were previously cleared in 510(k) K133134.

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System:	SonoSite X-Porte Ultrasound System
Transducer:	D2xp/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(C)	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				E			E
Cardiac Pediatric				E			E
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel
Other (spec.)

Table 1.3-5: Diagnostic Ultrasound Indications for Use Form – D2xp/2 MHz Transducer

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
6: B+PWD and (B+C)+PWD includes Simultaneous PW

All items marked "E" were released via Letter to File/Non-filing Justification documentation since K152209.

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System:	SonoSite X-Porte Ultrasound System
Transducer:	HFL38xp/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	ColorDoppler(C)	Combined(Spec.)	Other(Spec.)
Ophthalmic
Fetal	P	P	P	P	B+M; B+PWD; B+C;(B+C)+PWD	1,4,5
Abdominal	P	P	P	P	B+M; B+PWD; B+C;(B+C)+PWD	1,4,5
Intra-operative (Abdominalorgans and vascular)
Intra-operative (Neuro.)
Laparoscopic	P	P	P	P	B+M; B+PWD; B+C;(B+C)+PWD	1,4,5
Pediatric	P	P	P	P	B+M; B+PWD; B+C;(B+C)+PWD	1,4,5
Small Organ (breast, thyroid,testicles. prostate)	P	P	P	P	B+M; B+PWD; B+C;(B+C)+PWD	1,4,5
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)	P	P	P	P	B+M; B+PWD; B+C;(B+C)+PWD	1,4,5
Musculo-skel. (Convent.)	P	P	P	P	B+M; B+PWD; B+C;(B+C)+PWD	1,4,5
Musculo-skel. (Superfic.)	P	P	P	P	B+M; B+PWD; B+C;(B+C)+PWD	1,4,5
Intra-luminal
Other (spec.)
Cardiac Adult	P	P	P	P	B+M; B+PWD; B+C;(B+C)+PWD	1,5
Cardiac Pediatric	P	P	P	P	B+M; B+PWD; B+C;(B+C)+PWD	1,5
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	P	P	P	P	B+M; B+PWD; B+C;B+PW; (B+C)+PWD	1,4,5,6
Other (spec.)

Table 1.3-6: Diagnostic Ultrasound Indications for Use Form – HFL38xp/13-6 MHz Transducer

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

6: B+PWD and (B+C)+PWD includes Simultaneous PW

All items marked "P" were previously cleared in 510(k) K152209 and K142017.

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Table 1.3-7: Diaqnostic Ultrasound Indications for Use Form – HFL50xp/15-6 MHz Transducer

System:	SonoSite X-Porte Ultrasound System
Transducer:	HFL50xp/15-6 MHz Transducer
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the humanbody as follows:
Clinical Application	B	M	PWD	CWD	ColorDoppler(C)	Combined(Spec.)	Other(Spec.)
Ophthalmic
Fetal	P	P	P		P	B+M; B+PWD; B+C;(B+C)+PWD	1,4,5
Abdominal
Intra-operative (Abdominalorgans and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P	P		P	B+M; B+PWD; B+C;(B+C)+PWD	1,4,5
Small Organ (breast, thyroid,testicles. prostate)	P	P	P		P	B+M; B+PWD; B+C;(B+C)+PWD	1,4,5
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)	P	P	P		P	B+M; B+PWD; B+C;(B+C)+PWD	1,4,5
Musculo-skel. (Convent.)	P	P	P		P	B+M; B+PWD; B+C;(B+C)+PWD	1,4,5
Musculo-skel. (Superfic.)	P	P	P		P	B+M; B+PWD; B+C;(B+C)+PWD	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+C;(B+C)+PWD	1,4,5
Other (spec.)

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

6: B+PWD and (B+C)+PWD includes Simultaneous PW

All items marked "P" were previously cleared in 510(k) K133134.

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Table 1.3-8: Diagnostic Ultrasound Indications for Use Form - HSL25xp/13-6 MHz Transducer
-------------------------------------------------------------------------------------------	--

System:	SonoSite X-Porte Ultrasound System
Transducer:	HSL25xp/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(C)	Combined(Spec.)	Other(Spec.)
Ophthalmic	P	P	P		P	B+M; B+PWD; B+C;(B+C)+PWD	1,4,5
Fetal	P	P	P		P	B+M; B+PWD; B+C;(B+C)+PWD	1,4,5
Abdominal	P	P	P		P	B+M; B+PWD; B+C;(B+C)+PWD	1,4,5
Intra-operative (Abdominalorgans and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P	P		P	B+M; B+PWD; B+C;(B+C)+PWD	1,4,5
Small Organ (breast, thyroid,testicles. prostate)	P	P	P		P	B+M; B+PWD; B+C	1,4,5
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)	P	P	P		P	B+M; B+PWD; B+C;(B+C)+PWD	1,4,5
Musculo-skel. (Convent.)	P	P	P		P	B+M; B+PWD; B+C;(B+C)+PWD	1,4,5
Musculo-skel. (Superfic.)	P	P	P		P	B+M; B+PWD; B+C	1,4,5
Intra-luminal
Other (spec.)
Cardiac Adult	P	P	P		P	B+M; B+PWD; B+C;(B+C)+PWD	1,5
Cardiac Pediatric	P	P	P		P	B+M; B+PWD; B+C;(B+C)+PWD	1,5
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	P	P	P		P	B+M; B+PWD; B+C;(B+C)+PWD	1,4,5,6
Other (spec.)

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

6: B+PWD and (B+C)+PWD includes Simultaneous PW

All items marked "P" were previously cleared in 510(k) K142017.

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

System:	SonoSite X-Porte Ultrasound System
Transducer:	ICTxp/9-5 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(C)	Combined(Spec.)	Other(Spec.)
Ophthalmic	P	P	P		P	B+M; B+PWD; B+C;(B+C)+PWD	1,5
Fetal	P	P	P		P	B+M; B+PWD; B+C;(B+C)+PWD	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	P	P	P		P	B+M; B+PWD; B+C;(B+C)+PWD	1,5
Trans-vaginal	P	P	P		P	B+M; B+PWD; B+C;(B+C)+PWD	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.)

Table 1.3-9: Diagnostic Ultrasound Indications for Use Form – ICTxp/9-5 MHz Transducer

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

6: B+PWD and (B+C)+PWD includes Simultaneous PW

All items marked "P" were previously cleared in 510(k) K133134.

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

System:	SonoSite X-Porte Ultrasound System
Transducer:	L25xp/13-6 MHz Transducer
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human
	body as follows:
Clinical Application	Mode of Operation
	Color
					Doppler	Combined	Other
	B	M	PWD	CWD	(C)	(Spec.)	(Spec.)
Ophthalmic	P	P	P		P	B+M; B+PWD; B+C;(B+C)+PWD	1,5
Fetal
Abdominal	P	P	P		P	B+M; B+PWD; B+C;(B+C)+PWD	1,4,5
Intra-operative (Abdominalorgans and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P	P		P	B+M; B+PWD; B+C;(B+C)+PWD	1,4,5
Small Organ (breast, thyroid,testicles, prostate)	P	P	P		P	B+M; B+PWD; B+C;(B+C)+PWD	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+C;(B+C)+PWD	1,4,5
Musculo-skel. (Superfic.)	P	P	P		P	B+M; B+PWD; B+C;(B+C)+PWD	1,4,5
Intra-luminal
Other (spec.)
Cardiac Adult	P	P	P		P	B+M; B+PWD; B+C;(B+C)+PWD	1,5
Cardiac Pediatric	P	P	P		P	B+M; B+PWD; B+C;(B+C)+PWD	1,5
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	P	P	P		P	B+M; B+PWD; B+C;(B+C)+PWD	1,4,5,6
Other (spec.)

Table 1.3-10: Diagnostic Ultrasound Indications for Use Form - L25xp/13-6 MHz Transducer

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

6: B+PWD and (B+C)+PWD includes Simultaneous PW

All items marked "P" were previously cleared in 510(k) K142017 and K133134.

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

Table 1.3-11: Diaqnostic Ultrasound Indications for Use Form – L38xp/10-5 MHz Transducer
------------------------------------------------------------------------------------------	--

System:	SonoSite X-Porte Ultrasound System
Transducer:	L38xp/10-5 MHz Transducer
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the humanbody as follows:
Clinical Application	Mode of Operation
	B	M	PWD	CWD	ColorDoppler(C)	Combined(Spec.)	Other(Spec.)
Ophthalmic
Fetal	P	P	P
Abdominal	P	P	P		P	B+M; B+PWD; B+C;(B+C)+PWD	1,4,5
Intra-operative (Abdominalorgans and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P	P		P	B+M; B+PWD; B+C;(B+C)+PWD	1,4,5
Small Organ (breast, thyroid,testicles. prostate)	P	P	P		P	B+M; B+PWD; B+C;(B+C)+PWD	1,4,5
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)	P	P	P		P	B+M; B+PWD; B+C;(B+C)+PWD	1,4,5
Musculo-skel. (Convent.)	P	P	P		P	B+M; B+PWD; B+C;(B+C)+PWD	1,4,5
Musculo-skel. (Superfic.)	P	P	P		P	B+M; B+PWD; B+C;(B+C)+PWD	1,4,5
Intra-luminal
Other (spec.)
Cardiac Adult	P	P	P		P	B+M; B+PWD; B+C;(B+C)+PWD	1,5
Cardiac Pediatric	P	P	P		P	B+M; B+PWD; B+C;(B+C)+PWD	1,5
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	P	P	P		P	B+M; B+PWD; B+C;(B+C)+PWD	1,4,5,6
Other (spec.)

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

6: B+PWD and (B+C)+PWD includes Simultaneous PW

All items marked "P" were previously cleared in 510(k) K142017 and K133134.

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

					Table 1.3-12: Diagnostic Ultrasound Indications for Use Form - P10xp/8-4 MHz Transducer
--	--	--	--	--	-----------------------------------------------------------------------------------------

System:	SonoSite X-Porte Ultrasound System
Transducer:	P10xp/8-4 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(C)	Combined(Spec.)	Other(Spec.)
Ophthalmic	P	P	P		P	B+M; B+PWD; B+C;(B+C)+PWD	1
Fetal	P	P	P		P	B+M; B+PWD; B+CWD;B+C; (B+C)+PWD	1
Abdominal	P	P	P		P	B+M; B+PWD; B+CWD;B+C; (B+C)+PWD	1
Intra-operative (Abdominalorgans and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P	P		P	B+M; B+PWD; B+C;(B+C)+PWD	1
Small Organ (breast, thyroid,testicles. prostate)	P	P	P		P	B+M; B+PWD; B+C;(B+C)+PWD	1
Neonatal Cephalic	P	P	P		P	B+M; B+PWD; B+C;(B+C)+PWD	1
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)	P	P	P		P	B+M; B+PWD; B+C;(B+C)+PWD	1
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Intra-luminal
Other (spec.)
Cardiac Adult	P	P	P	P	P	B+M; B+PWD; B+CWD;B+C; (B+C)+PWD;(B+C)+CWD	1,3
Cardiac Pediatric	P	P	P	P	P	B+M; B+PWD; B+CWD;B+C; (B+C)+PWD;(B+C)+CWD	1,3
Trans-esophageal (card.)
Other (spec.)	P	P	P		P	B+M; B+PWD; B+C;(B+C)+PWD	1
Peripheral vessel
Other (spec.)
System:	SonoSite X-Porte Ultrasound System
Transducer:	rP19xp/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	ColorDoppler(C)	Combined(Spec.)	Other(Spec.)
Ophthalmic	E	E	E		E	B+M; B+PWD; B+C;(B+C)+PWD	1-2
Fetal	E	E	E		E	B+M; B+PWD; B+C;(B+C)+PWD	1-3
Abdominal	E	E	E		E	B+M; B+PWD; B+CWD;B+C; (B+C)+PWD;(B+C)+CWD	1-2
Intra-operative (Abdominalorgans and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	E	E	E		E	B+M; B+PWD; B+C;(B+C)+PWD	1-3
Small Organ (breast, thyroid,testicles, prostate)	E	E	E		E	B+M; B+PWD; B+C;(B+C)+PWD	1-3
Neonatal Cephalic	E	E	E		E	B+M; B+PWD; B+C;(B+C)+PWD	1
Adult Cephalic	E	E	E		E	B+M; B+PWD; B+C;(B+C)+PWD	1
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)	E	E	E		E	B+M; B+PWD; B+C;(B+C)+PWD	1-2
Musculo-skel. (Superfic.)
Intra-luminal
Other (spec.)
Cardiac Adult	E	E	E	E	E	B+M; B+PWD; B+CWD;B+C; (B+C)+PWD;(B+C)+CWD	1-3
Cardiac Pediatric	E	E	E	E	E	B+M; B+PWD; B+CWD;B+C; (B+C)+PWD;(B+C)+CWD	1-3
Trans-esophageal (card.)
Other (spec.)	E	E	E		E	B+M; B+PWD; B+C;(B+C)+PWD	1-2
Peripheral vessel
Other (spec.)
System:	SonoSite X-Porte Ultrasound System
Transducer:	P21xp/5-1 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(C)	Combined(Spec.)	Other(Spec.)
Ophthalmic	P	P	P		P	B+M; B+PWD; B+C;(B+C)+PWD	1
Fetal	P	P	P		P	B+M; B+PWD; B+C;(B+C)+PWD	1-3
Abdominal	P	P	P		P	B+M; B+PWD; B+CWD;B+C; (B+C)+PWD;(B+C)+CWD	1-3
Intra-operative (Abdominalorgans and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P	P		P	B+M; B+PWD;B+CWD; B+C	1-3
Small Organ (breast, thyroid,testicles, prostate)	P	P	P		P	B+M; B+PWD; B+C;(B+C)+PWD	1-3
Neonatal Cephalic	P	P	P		P	B+M; B+PWD; B+C;(B+C)+PWD	1-3
Adult Cephalic	P	P	P		P	B+M; B+PWD; B+C;(B+C)+PWD	1-3
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)	P	P	P		P	B+M; B+PWD; B+C;(B+C)+PWD	1-3
Musculo-skel. (Superfic.)
Intra-luminal
Other (spec.)	P	P	P	P	P	B+M; B+PWD; B+CWD;B+C; (B+C)+PWD;(B+C)+CWD	1-3
Cardiac Adult	P	P	P	P	P	B+M; B+PWD; B+CWD;B+C; (B+C)+PWD;(B+C)+CWD	1-3
Cardiac Pediatric	P	P	P	P	P	B+M; B+PWD; B+CWD;B+C; (B+C)+PWD;(B+C)+CWD	1-3
Trans-esophageal (card.)						(B+C)+CWD
Other (spec.)
Peripheral vessel	P	P	P		P	B+M; B+PWD; B+C;(B+C)+PWD	1-3
Other (spec.)
System:	SonoSite X-Porte Ultrasound System
Transducer:	TEExp/8-3 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(C)	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
	P	P	P	P	P	B+M; B+PWD; B+CWD;B+C;	1,3
Trans-esophageal (card.)						(B+C)+PWD; (B+C)+CWD
Other (spec.)
Peripheral vessel
Other (spec.)

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

6: B+PWD and (B+C)+PWD includes Simultaneous PW

All items marked "P" were previously cleared in 510(k) K142017.

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

Table 1.3-13 – Diagnostic Ultrasound Indications for Use Form – rP19xp/5-1 MHz Transducer

Additional Comments:

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 Simultaneous 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

6: B+PWD and (B+C)+PWD includes Update and Simultaneous PW

All items marked "E" were released via Letter to File/Non-filing Justification documentation since K152209. Prescription Use (Per 21 CFR 801.109)

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

Table 1.3-14: Diagnostic Ultrasound Indications for Use Form – P21xp/5-1 MHz Transducer

Additional Comments:

1: Includes imaging to assist in the placement of needles and catheters in vascular or other and imaging guidance for peripheral nerve block procedures. Color Doppler includes Power/Velocity/Variance. M-Mode includes Simultaneous 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
6: B+PWD and (B+C)+PWD includes Update and Simultaneous PW

All items marked "P" were previously cleared in 510(k) K142017 and K133134. Prescription Use (Per 21 CFR 801.109)

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

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

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

6: B+PWD and (B+C)+PWD includes Update and Simultaneous PW

All items marked "P" were previously cleared in 510(k) K152209.

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

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 Lydia GrimmerSr. Regulatory Affairs Specialist
E-mail:	jordan.grimmer@fujilfim.com
Telephone:	(425) 951-6984
Facsimile:	(425) 951-1201
Date prepared:	April 19, 2017

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 X-Porte™ 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 X-Porte Ultrasound System	K152209
SonoSite Edge Ultrasound System	K133454
SonoSite Edge II Ultrasound System	K162045

4) Device Description:

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

5) Intended Use:

The SonoSite X-Porte 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 Small Organ (breast, thyroid, testicles, prostate) Neonatal Cephalic Adult Cephalic Trans-vaginal Musculo-skel. (Convent.) Musculo-skel. (Superfic.) Cardiac Adult Cardiac Pediatric Trans-esophageal (card.) Peripheral Vessel

6) Technological Characteristics:

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

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7) Determination of Substantial Equivalence:

Summary of Non-Clinical Tests:

The X-Porte Ultrasound System has been evaluated for electrical, thermal, mechanical and EMC safety. Additionally, cleaning/disinfection, biocompatibility, and acoustic output have been evaluated, and the device has been found to conform to applicable mandatory medical device safety standards. Assurance of quality was established by employing the following elements of product development: Design Phase Reviews. Risk Assessment, Requirement, System and Software Verification, Hardware Verification, Safety Compliance Verification, Clinical Validation. All patient contact materials are biocompatible. Reports for these elements of product development are referenced in Attachment 6.

Reference No.	Title
AAMI / ANSI / ISO10993-1	ISO 10993-1:2009/(R)2013, Biological evaluation of medical devices -- Part 1:Evaluation and testing within a risk management process
IEC 60601-1	AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012,, C1:2009/(R)2012 andA2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: Generalrequirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
IEC 60601-1-2	AAMI / ANSI / IEC 60601-1-2:2007(R)2012, Medical electrical equipment - Part 1-2:General requirements for basic safety and essential performance - Collateralstandard: Electromagnetic compatibility - Requirements and tests (Edition 3)
IEC 60601-2-37	IEC 60601-2-37:2007, Particular Requirements for the basic safety and essentialperformance of ultrasonic medical diagnostic and monitoring equipment
IEC 62359	IEC 62359:2010, Ultrasonics – Field Characterization – Test Methods For TheDetermination Of Thermal And Mechanical Indices Related To Medical DiagnosticUltrasonic Fields [Including: Technical Corrigendum 1 (2011)] (Edition 2)
ISO 14971	ISO 14971: 2007, Medical devices - Application of risk management to medicaldevices
NEMA UD 2-2004	Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
NEMA PS 3.15	NEMA Ps 3.15:2011, Digital Imaging and Communications in Medicine (DICOM),Part 15: Security and System Management Profiles

The X-Porte Ultrasound System is designed to comply with the following voluntary standards.

Summary of Clinical Tests:

The SonoSite X-Porte Ultrasound System and transducers, subject of this submission, did not reguire 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 X-Porte device and predicates conform to applicable electromedical device safety standards with compliance verified through independent evaluation. The X-Porte device and predicates meet FDA requirements for Track 3 devices, share indications for use, have biosafety equivalence and are manufactured using the same ISO 13485 quality system. FUJIFILM SonoSite, Inc. believes that the X-Porte 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 X-PorteUltrasound System(This submission)	SonoSite X-PorteUltrasound System(K152209)	SonoSite EdgeUltrasound System(K133454)	SonoSite Edge IIUltrasound System(K162045)
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	OphthalmicFetal - OB/GYNAbdominal	OphthalmicFetal - OB/GYNAbdominalIntraoperative (abdominalorgans and vascular)	OphthalmicFetal - OB/GYNAbdominalIntraoperative (abdominalorgans and vascular)Intra-operative (Neuro.)	OphthalmicFetal - OB/GYNAbdominal
	PediatricSmall Organ (breast,thyroid, testicle, prostate)Neonatal CephalicAdult Cephalic	PediatricSmall Organ (breast,thyroid, testicle, prostate)Neonatal CephalicAdult Cephalic	PediatricSmall Organ (breast,thyroid, testicle, prostate)Neonatal CephalicAdult CephalicTrans-Rectal	PediatricSmall Organ (breast,thyroid, testicle, prostate)Neonatal CephalicAdult CephalicTrans-Rectal
	Trans-VaginalMusculo-skeletal(Conventional)Musculo-skeletal(Superficial)Cardiac AdultCardiac PediatricTrans-esophageal(cardiac)Peripheral Vessel	Trans-VaginalMusculo-skeletal(Conventional)Musculo-skeletal(Superficial)Cardiac AdultCardiac PediatricTrans-esophageal(cardiac)Peripheral Vessel	Trans-VaginalMusculo-skeletal(Conventional)Musculo-skeletal(Superficial)Cardiac AdultCardiac PediatricTrans-esophageal(cardiac)Peripheral Vessel	Trans-VaginalMusculo-skeletal(Conventional)Musculo-skeletal(Superficial)Cardiac AdultCardiac PediatricTrans-esophageal(cardiac)Peripheral Vessel
Feature	SonoSite X-PorteUltrasound System(This submission)	SonoSite X-PorteUltrasound System(K152209)	SonoSite EdgeUltrasound System(K133454)	SonoSite Edge IIUltrasound System(K162045)
	Needleguidance	Needleguidance	Needleguidance	Needleguidance
TransducerTypes	Linear ArrayCurved Linear ArrayIntracavitaryPhased ArrayStatic ProbesTrans-esophageal	Linear ArrayCurved Linear ArrayIntracavitaryPhased ArrayTrans-esophageal	Linear ArrayCurved Linear ArrayIntracavitaryPhased ArrayStatic ProbesTrans-esophageal	Linear ArrayCurved Linear ArrayIntracavitaryPhased ArrayTrans-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	$I_{spta.3}$ : 629.3 (P21xp)TI Type: TIB (P21xp)TI Value: 4.0 (P21xp)MI: 1.7 (P21xp)$I_{pa.3}$ @MI Max: 678 (L38xp)	$I_{spta.3}$ : 629.3 (P21xp)TI Type: TIB (P21xp)TI Value: 4.0 (P21xp)MI: 1.7 (P21xp)$I_{pa.3}$ @MI Max: 678 (L38xp)	$I_{spta.3}$ : 709 (TEEx)TI Type: TIB (P21x)TI Value: 3.7 (P21x)MI: 1.51 (P21x)$I_{pa.3}$ @MI Max: 776 (L38xi)	$I_{spta.3}$ : 598.9 (HFL50x)TI Type: TIB (rP19x)TI Value: 4.98 (rP19x)MI: 1.7 (rP19x)$I_{pa.3}$ @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	Display Feature for HigherOutputsMI Output DisplayTI Output Display
Feature	SonoSite X-PorteUltrasound System(This submission)	SonoSite X-PorteUltrasound System(K152209)	SonoSite EdgeUltrasound System(K133454)	SonoSite Edge IIUltrasound System(K162045)
Modes ofOperation	B-mode GrayscaleImagingTissue Harmonic ImagingM-modeSimultaneous M-ModeColor Power DopplerZoomCombination ModesSimultaneous PW ImagingPulsed Wave (PW)DopplerContinuous Wave (CW)DopplerSonoHD2 NoiseReductionSonoMB/MBe ImageCompoundingSteered CW DopplerVelocity Color DopplerTissue Doppler Imaging(TDI)	B-mode GrayscaleImagingTissue Harmonic ImagingM-modeSimultaneous M-ModeColor Power DopplerZoomCombination ModesPulsed Wave (PW)DopplerContinuous Wave (CW)DopplerSonoHD2 NoiseReductionSonoMB/MBe ImageCompoundingSteered CW DopplerVelocity Color DopplerTissue Doppler Imaging(TDI)	B-mode GrayscaleImagingTissue Harmonic ImagingM-modeColor M-ModeColor Power DopplerZoomCombination ModesPulsed Wave (PW)DopplerContinuous Wave (CW)DopplerSonoHD2 NoiseReductionSonoMB/MBe ImageCompoundingSteered CW DopplerVelocity Color DopplerTissue Doppler Imaging(TDI)	B-mode GrayscaleImagingTissue Harmonic ImagingM-modeColor M-ModeColor Power DopplerZoomCombination ModesPulsed Wave (PW)DopplerContinuous Wave (CW)DopplerSonoHD2 NoiseReductionSonoMB/MBe ImageCompoundingSteered CW DopplerVelocity Color DopplerTissue Doppler Imaging(TDI)
PW Doppler	Available on all imagingtransducers except D2xp.Adjustable sample volumesize: 1.0 – 25 mmSimultaneous or duplexmode of operationSimultaneous B-mode andPW DopplerHigh PRF capability	Available on all imagingtransducers.Adjustable sample volumesize: 1.0 – 25 mmSimultaneous or duplexmode of operationSimultaneous B-mode andPW DopplerHigh PRF capability	Available on all imagingtransducers except D2x/2MHz.Adjustable sample volumesize: 1.0 – 25 mmSimultaneous or duplexmode of operationSimultaneous B-mode andPW DopplerHigh PRF capability	Available on all imagingtransducers except P11x.Adjustable sample volumesize: 1.0 – 25 mmSimultaneous or duplexmode of operationSimultaneous B-mode andPW DopplerHigh PRF capability
CW Doppler	Available on D2xp, P10xp,rP19xp, P21xp, TEExpSimultaneous or duplexmode of operationSimultaneous B-mode andCW Doppler	Available on P10xp,P21xp, TEExpSimultaneous or duplexmode of operationSimultaneous B-mode andCW Doppler	Available on C11x, D2x,P10x, P21x, TEExSimultaneous or duplexmode of operationSimultaneous B-mode andCW Doppler	Available on P10x, rP19x,TEExiSimultaneous or duplexmode of operationSimultaneous B-mode andCW Doppler
Velocity ColorDoppler	Available on alltransducers except D2xp.	Available on alltransducers	Available on alltransducers except D2x	Available on alltransducers
Elastography(Strain), andStrain RateImaging	Not available	Not available	Available on alltransducers except D2x	Not available
Feature	SonoSite X-PorteUltrasound System(This submission)	SonoSite X-PorteUltrasound System(K152209)	SonoSite EdgeUltrasound System(K133454)	SonoSite Edge IIUltrasound System(K162045)
ECG Feature	One 3-lead ECG input, orOne external ECG input,orECG Slave CableOne other physio input	One 3-lead ECG input, orOne external ECG input,orOne other physio input	One 3-lead ECG input, orOne external ECG input,orOne other physio input	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,Modality Worklist, PerformProcedure Step (PPS),Storage Commitment	DICOM 3.0 Store, Print,and Modality Worklistservice class user features	DICOM 3.0 Store, Print,Modality Worklist, PerformProcedure Step (PPS),Storage Commitment
IMTMeasurement	Not available	Not available	SonoCalc IMT providesthe capability forautomated measurementof intima-media thickness(IMT) of the carotid artery.IMT functionality isavailable both on theultrasound system and ina stand alone softwareprogram that runs on apersonal computer.	Not available
#TransmitChannels	128 digital channels	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)	64 digital channels(128 digital channels usingSynthetic Aperture)
Patient ContactMaterials	Transducers:Acrylonitrile-butadien-styrene (ABS)CycoloyDow Medical Adhesive,Type AEpoxy paste adhesiveEpoxy resinPolyetherimidePolyethylene (PE)lonomerPolyetheretherketone(PEEK)Polysulfone UDEL P1700PolyurethanePoly-Vinyl-Chloride (PVC)Silicone RTV AdhesiveSilicone RubberUrethaneNeedle Guides:Acetal copolymerAcrylonitrile-butadien-styrene (ABS)	Transducers:Acrylonitrile-butadien-styrene (ABS)CycoloyDow Medical Adhesive,Type AEpoxy paste adhesivePolyethylene (PE)lonomerPolyetheretherketone(PEEK)Polysulfone UDEL P1700PolyurethanePoly-Vinyl-Chloride (PVC)Silicone RTV AdhesiveSilicone RubberUrethaneNeedle Guides:Acetal copolymerAcrylonitrile-butadien-styrene (ABS)	Transducers:Acrylonitrile-butadien-styrene (ABS)CycoloyDow Medical Adhesive,Type AEpoxy paste adhesiveEpoxy resinPolyetherimidePolyethylene (PE)lonomerPolyetheretherketone(PEEK)PolycarbonatePolysulfone UDEL P1700PolyurethanePoly-Vinyl-Chloride (PVC)Silicone RTV AdhesiveSilicone RubberUrethaneNeedle Guides:Acetal copolymerAcrylonitrile-butadien-styrene (ABS)	Transducers:Acrylonitrile-butadien-styrene (ABS)CycoloyEpoxy paste adhesivePolyethylene (PE)lonomerPolyetheretherketone(РЕЕК)PolycarbonatePolysulfone UDEL P1700PolyurethanePoly-Vinyl-Chloride (PVC)Silicone RTV AdhesiveSilicone RubberUrethaneNeedle Guides:Acetal copolymerAcrylonitrile-butadien-styrene (ABS)
Feature	SonoSite X-PorteUltrasound System(This submission)	SonoSite X-PorteUltrasound System(K152209)	SonoSite EdgeUltrasound System(K133454)	SonoSite Edge IIUltrasound System(K162045)
Product SafetyCertification	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 UD2-2004IEC 62359:2010	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 UD2-2004IEC 62359:2010	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 (NEMAUD3-2004 (R2009))	AAMI/ANSI ES60601-1:2005 (R2012)IEC 60601-2-37: 2007CAN/CSA C22.2 No.60601-1:08NEMA UD2-2004IEC 62359:2010
EMCCompliance	IEC 60601-1-2:2007CISPR 11IEC 61000-4 pt 2-5	IEC 60601-1-2:2007CISPR 11IEC 61000-4 pt 2-5	IEC 60601-1-2:2007CISPR 11IEC 61000-4 pt 2-5	AAMI / ANSI / IEC 60601-1-2:2007(R)2012CISPR 11, Group 1, ClassA
DICOM	NEMA PS3.15 2003	NEMA PS3.15 2003	NEMA PS3.15 2003	NEMA PS3.15 2003
AirborneEquipmentStandards	RTCA/DO160D (section21)	RTCA/DO160D (section21)	RTCA/DO160D (section21)	RTCA/DO160 (section 21)
SystemCharacteristics	X-Porte (standconfiguration):Beamformer 128/128using SA (configurable)12.1" Capacitive touchscreen interface19" LED LCD HD monitor256 gray shades on LEDLCD	X-Porte (standconfiguration):Beamformer 128/128using SA (configurable)12.1" Capacitive touchscreen interface19" LED LCD HD monitor256 gray shades on LEDLCD6 USB 2.0 ports	Edge:Beamformer 128/128using SA (configurable)Hand held display andcontrolSingle 12.1" Liquid CrystalDisplay (LCD)256 gray shades on LCD2 USB ports	Edge II:Beamformer 128/128using SA (configurable)Hand held display andcontrolSingle 12.1" Liquid CrystalDisplay (LCD)256 gray shades on LCD
	6 USB 2.0 portsStand Base Dimensions:26.4" L x 21.2" WStand Height (max): 64"(monitor up)Stand Height (min): 42.2"(monitor down)	Stand Base Dimensions:26.4" L x 21.2" WStand Height (max): 64"(monitor up)Stand Height (min): 42.2"(monitor down)	Dimensions: 12.9"(W) x12.4 (L) x 2.5"(H)	2 USB portsDimensions: 12.8"(W) x12.1" (L) x 2.5"(H)
	Weight: 149.35 lbs (fullyconfigured w/ 3transducersSystem operates viabattery or AC powerBattery life: 1 houroperational - 3 days idle	Weight: 149.35 lbs (fullyconfigured w/ 3transducersSystem operates viabattery or AC powerBattery life: 1 houroperational - 3 days idle	Weight: 8.5 lbsBattery operated (1.5 - 4hour operation per charge)System operates viabattery or AC power	Weight: 9.0 lbsSystem operates viabattery or AC powerBattery life: 1.5 - 4 houroperation per charge
	Input: 100 - 240 VAC,50/60 HzOutput 1: 24VDC output,275 W max	Input: 100 – 240 VAC,50/60 HzOutput 1: 24VDC output,275 W maxOutput 2: 100-240VAC,50-60 Hz (AC Printer)	100 - 240V options, 50/60Hz, 15VDC output	100 - 240V options, 50/60Hz, 15VDC output
Feature	SonoSite X-PorteUltrasound System(This submission)	SonoSite X-PorteUltrasound System(K152209)	SonoSite EdgeUltrasound System(K133454)	SonoSite Edge IIUltrasound System(K162045)
	Output 2: 100-240VAC, 50-60 Hz (AC Printer, DC Printer)	Various obstetrical,	Various obstetrical,	Various obstetrical,
	Various obstetrical, cardiac, volume, M-mode, PW and CW Doppler measurement and calculation packages	cardiac, volume, M-mode, PW and CW Doppler measurement and calculation packages	cardiac, volume, M-mode, PW and CW Doppler measurement and calculation packages	cardiac, volume, M-mode, PW and CW Doppler measurement and calculation packages
	ECG acquisition and display capabilities CW/PW Doppler Audio Spectral Doppler Audio and image storage on removable media Measurement on Recalled Images.	ECG acquisition and display capabilities CW/PW Doppler Audio Spectral Doppler Audio and image storage on removable media Measurement on Recalled Images.	ECG acquisition and display capabilities CW/PW Doppler Audio Spectral Doppler Audio and image storage on removable media	ECG acquisition and display capabilities CW/PW Doppler Audio Spectral Doppler Audio and image storage on removable media
	Wireless 802.11 (a/b/g/n) support for image transfer	Wireless 802.11 (a/b/g/n) support for image transfer	Wireless 802.11 (a/b/g) support for image transfer	Wireless 802.11 (b/g/n) support for image transfer
	X-Porte (desktop configuration):	X-Porte (desktop configuration):
	Same software features/capabilities as the stand configuration. Does not have the stand, touch panel interface, DVR, and mobile power unit.	Same software features/capabilities as the stand configuration. Does not have the stand, touch panel interface, DVR, and mobile power unit.
	Weight: 32.80 lbs (w/ 1 transducer)	Weight: 32.80 lbs (w/ 1 transducer)
	AC power only.100 - 240V options, 50/60 Hz	AC power only.100 - 240V options, 50/60 Hz
510(k) Track	Track 3	Track 3	Track 3	Track 3