The FUJIFILM SonoSite X-Porte Ultrasound System is a general purpose ultrasound system intended for use by a qualified physician 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
Intra-operative (Abdominal organs and vascular)
Pediatric
Small Organ (breast, thyroid, testicles, prostate)
Neonatal Cephalic
Adult Cephalic
Trans-vaginal
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Cardiac Adult
Cardiac Pediatric
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 readliy 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

This report is a 510(k) Premarket Notification for the FUJIFILM SonoSite X-Porte Ultrasound System. It is a submission to the FDA to demonstrate substantial equivalence to a previously cleared device, not a study to prove a device meets specific performance criteria in the way a clinical trial would for a novel device or AI.

Therefore, the document does not contain acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy) for an AI or diagnostic algorithm, nor does it describe a study that explicitly proves the device meets such criteria. Instead, it demonstrates substantial equivalence to predicate devices for its intended uses.

Based on the provided text, here's an analysis of the requested information, understanding that this is a medical device clearance document based on substantial equivalence, not a clinical performance study of an AI device:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) for an ultrasound system, not an AI diagnostic algorithm, there are no specific diagnostic acceptance criteria (like sensitivity, specificity, or AUC) and corresponding reported performance metrics in the document. The "acceptance criteria" for a 510(k) submission revolve around demonstrating that the new device is as safe and effective as a legally marketed predicate device.

The tables within the document detail the intended uses and modes of operation for the X-Porte Ultrasound System and its various transducers, comparing them to predicate devices (K133134 and K133454). The "performance" demonstrated is that the device functions according to its intended use and complies with relevant safety and performance standards.

Acceptance Criteria (Implied by 510(k) process)	Reported Device Performance (as demonstrated for 510(k))
Safety and Effectiveness Equivalence: New device is as safe and effective as identified predicate devices for claimed indications for use.	The FUJIFILM SonoSite X-Porte Ultrasound System has "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." Many intended clinical applications and modes of operation are described as "P" (previously cleared) or "N" (new indications for this specific transducer/system, which implies they have been deemed equivalent or safe and effective based on the provided technical information and comparison to predicates). The document explicitly states: "FUJIFILM SonoSite, Inc. believes that the X-Porte Ultrasound System is substantially equivalent with regard to safety and effectiveness to the predicate devices."
Compliance with Voluntary Standards: Device adheres to recognized national and international safety, performance, EMC, and biocompatibility standards.	Non-Clinical Tests: Evaluated for electrical, thermal, mechanical, EMC safety, cleaning/disinfection, biocompatibility, and acoustic output. Found to conform to applicable mandatory medical device safety standards. Voluntary Standards Met: AAMI/ANSI/ISO 10993-1, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62359, ISO 14971, NEMA UD 2-2004, NEMA PS 3.15. Quality Assurance: Established by Design Phase Reviews, Risk Assessment, Requirement, System and Software Verification, Hardware Verification, Safety Compliance Verification, Clinical Validation. All patient contact materials are biocompatible.
Acoustic Output Limits: Meets specified limits for acoustic intensity and indices.	Acoustic Output Display & FDA Limits: `ISTPA.3 ≤ 720 (mW/cm^2)`, `TI ≤ 4.0`, `MI ≤ 1.9` (These are the limits the device must meet, and are listed as features of the system).
Technological Characteristics Equivalence: Shares fundamental technology, transducer types, frequency range, and modes of operation with predicates.	A detailed comparison table ({16}) shows that the X-Porte Ultrasound System generally uses the same transducer types, frequency, acoustic output limits, and modes of operation as its predicate devices (K133134 and K133454), with some minor differences or additions that were deemed equivalent.

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

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

Therefore, there is no test set of patient data (images, etc.) described with a sample size or provenance (country of origin, retrospective/prospective). The assessment was based on non-clinical engineering tests and comparison to previously cleared devices.

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

Since no clinical studies or test sets with patient data were required, no experts were used to establish ground truth from such a test set. The evaluation relies on established engineering and regulatory standards and a determination of equivalence to predicate devices.

4. Adjudication Method for the Test Set

Not applicable, as no test set requiring ground truth adjudication was used.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done, as explicitly stated that clinical studies were not required. This submission is for an ultrasound hardware system, not an AI medical device that interprets images.

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

This refers to an ultrasound system, not a standalone algorithm. Performance was assessed through engineering characteristics and compliance with standards. So, no standalone algorithm performance study was done in the context of AI.

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

Given that clinical studies were not required, there was no ground truth derived from expert consensus, pathology, or outcomes data in the context of diagnostic performance. The "ground truth" in this submission relates to the verification of the device's technical specifications and safety standards (e.g., acoustic output measurements, electrical safety tests, biocompatibility tests). These are considered facts established through physical measurement and standardized test procedures, not through expert interpretation of clinical data in the way an AI diagnostic device would.

8. The Sample Size for the Training Set

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

9. How the Ground Truth for the Training Set was Established

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

In summary: This document is a 510(k) premarket notification for an ultrasound system, not an AI diagnostic software. The "acceptance criteria" are regulatory (demonstrating substantial equivalence to predicate devices and adherence to safety standards) rather than performance metrics for an AI algorithm. Clinical studies and associated concepts like test sets, ground truth derivation, and reader studies were not part of this clearance process.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with medicine and healthcare.

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

August 22, 2014

FUJIFILM SONOSITE, INC. C/O MARK JOB RESPONSIBLE THIRD PARTY OFFICIAL 1394 25TH STREET NW BUFFALO, MN 55313

Re: K142017

Trade/Device Name: 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: July 24, 2014 Received: July 25, 2014

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

This determination of substantial equivalence applies to the following transducers intended for use with the X-PORTE Ultrasound System, as described in your premarket notification:

Transducer Model Number
C11xp/8-5 MHz	C35xp/8-3 MHz	C60xp/5-2 MHz
HFL38xp/13-6 MHz	HFL50xp/15-6 MHz	HSL25xp/13-6 MHz
ICTxp/9-5 MHz	L25xp/13-6 MHz	L38xp/10-5 MHz
P10xp/8-4 MHz	P21xp/5-1 MHz

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.

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Page 2-Mr. Job

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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

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

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

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

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

Sincerely yours,

Smh. 7)

for

Janine M. Morris 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) TBD K142017

Device Name

FUJIFILM SonoSite X-Porte Ultrasound System

Indications for Use (Describe)

Ophthalmic
Fetal - OB/GYN
Abdominal
Intra-operative (Abdominal organs and vascular)
Pediatric
Small Organ (breast, thyroid, testicles, prostate)
Neonatal Cephalic
Adult Cephalic
Trans-vaginal
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
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)
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Prescription Use (Part 21 CFR 801 Subpart D)

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

----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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

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

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 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

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

Prescription Use (Per 21 CFR 801.109)

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

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

Prescription Use (Per 21 CFR 801.109)

Page 3 of 13

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System:	FUJIFILM SonoSite X-Porte Ultrasound System
Transducer:	C35xp/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	Combined(Spec.)	Other(Spec.)
Ophthalmic
Fetal
Abdominal	N	N	N		N	B+M; B+PWD; B+CD	1,2,5
Intra-operative (Abdominal	N	N	N		N	B+M; B+PWD; B+CD	1,2,5
organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	N	N	N		N	B+M; B+PWD; B+CD	1,2,5
Small Organ (breast, thyroid,
testicles. prostate)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)	N	N	N		N	B+M; B+PWD; B+CD	1,2,5
Musculo-skel. (Superfic.)
Intra-luminal
Other (spec.)
Cardiac Adult
Cardiac Pediatric
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	N	N	N		N	B+M; B+PWD; B+CD	1,2,5
Other (spec.)

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

Prescription Use (Per 21 CFR 801.109)

Page 4 of 13

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

Table 1.3-4: Diagnostic Ultrasound Indications for Use Form – C60xp/5-2 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) K133134.

Prescription Use (Per 21 CFR 801.109)

Page 5 of 13

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Table 1.3-5: Diagnostic Ultrasound Indications for Use Form – HFL38xp/13-6 Transducer

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

Prescription Use (Per 21 CFR 801.109)

Page 6 of 13

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Table 1.3-6: Diagnostic Ultrasound Indications for Use Form – HFL50xp/15-6 Transducer

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

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) K133134.

Prescription Use (Per 21 CFR 801.109)

Page 7 of 13

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Table 1.3-7: Diagnostic Ultrasound Indications for Use Form – HSL25xp/13-6 Transducer

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

Prescription Use (Per 21 CFR 801.109)

Page 8 of 13

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System:	FUJIFILM SonoSite X-Porte Ultrasound System
Transducer:	ICTxp/9-5 MHz Transducer
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application	B	M	PWD	CWD	Color Doppler	Combined (Spec.)	Other (Spec.)
Ophthalmic
Fetal	P	P	P		P	B+M; B+PWD; B+CD	1,5
Abdominal
Intra-operative (Abdominal organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric
Small Organ (breast, thyroid, testicles, prostate)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal	P	P	P		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.)

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

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) K133134.

Prescription Use (Per 21 CFR 801.109)

Page 9 of 13

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System:	FUJIFILM SonoSite X-Porte Ultrasound System
Transducer:	L25xp/13-6 MHz Transducer
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the humanbody as follows:
Clinical Application	B	M	PWD	CWD	ColorDoppler	Combined(Spec.)	Other(Spec.)
Ophthalmic	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Fetal	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Abdominal	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Intra-operative (Abdominalorgans and vascular)	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Small Organ (breast, thyroid,testicles, prostate)	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Musculo-skel. (Superfic.)	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Intra-luminal
Other (spec.)
Cardiac Adult	E	E	E		E	B+M; B+PWD; B+CD	1,4,5
Cardiac Pediatric	E	E	E		E	B+M; B+PWD; B+CD	1,4,5
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Other (spec.)

Table 1.3-9: Diagnostic Ultrasound Indications for Use Form – L25xp/13-6 Transducer

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

Additional Comments:

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

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

Prescription Use (Per 21 CFR 801.109)

Page 10 of 13

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System:	FUJIFILM SonoSite X-Porte Ultrasound System
Transducer:	L38xp/10-5 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	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Intra-operative (Abdominal organs and vascular)	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Small Organ (breast, thyroid, testicles. prostate)	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Musculo-skel. (Superfic.)	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Intra-luminal
Other (spec.)
Cardiac Adult	E	E	E		E	B+M; B+PWD; B+CD	1,4,5
Cardiac Pediatric	E	E	E		E	B+M; B+PWD; B+CD	1,4,5
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Other (spec.)

Table 1.3-10: Diagnostic Ultrasound Indications for Use Form – L38xp/10-5 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) K133134.

Prescription Use (Per 21 CFR 801.109)

Page 11 of 13

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

Table 1.3-11: Diagnostic Ultrasound Indications for Use Form – P10xp/8-4 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

Prescription Use (Per 21 CFR 801.109)

Page 12 of 13

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

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

Table 1.3-12: Diagnostic Ultrasound Indications for Use Form – P21xp/5-1 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) K133134.

Prescription Use (Per 21 CFR 801.109)

Page 13 of 13

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

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:	Patricia Liau
	Regulatory Affairs Specialist
E-mail:	Patricia.Liau@sonosite.com
Telephone:	(425) 951-6870
Facsimile:	(425) 951-6713
Date prepared:	July 2, 2014

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 (subject to change)

Classification Names

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

3) Identification of the predicate or leqally marketed device:

SonoSite X-Porte Ultrasound System K133134 SonoSite Edge Ultrasound System K133454

4) Device Description:

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5) Intended Use:

Ophthalmic Fetal - OB/GYN Abdominal Intra-operative (Abdominal organs and vascular) Pediatric Small Organ (breast, thyroid, testicles, prostate) Neonatal Cephalic Adult Cephalic Trans-vaginal Musculo-skel. (Convent.) Musculo-skel. (Superfic.) Cardiac Adult Cardiac Pediatric Peripheral Vessel

6) Technological Characteristics:

SonoSite X-Porte and Edge 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.

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

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.

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

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

Summary of Clinical Tests:

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

8) Conclusion:

Intended uses and other key features are consistent with traditional clinical practice and FDA quidance. 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(K133134)	SonoSite EdgeUltrasound System(K133454)
Intended Use	Diagnostic ultrasound imaging orfluid flow analysis of the humanbody	Diagnostic ultrasound imaging orfluid flow analysis of the humanbody	Diagnostic ultrasound imaging orfluid flow analysis of the humanbody
Indications forUse	OpthalmicFetal - OB/GYNAbdominalIntraoperative (abdominal organsand vascular)PediatricSmall Organ (breast, thyroid,testicle, prostate)Neonatal CephalicAdult CephalicTrans-VaginalMusculo-skeletal (Conventional)Musculo-skeletal (Superficial)Cardiac AdultCardiac PediatricPeripheral VesselNeedle guidance	OpthalmicFetal - OB/GYNAbdominalIntraoperative (abdominal organsand vascular)PediatricSmall Organ (breast, thyroid,testicle, prostate)Trans-VaginalMusculo-skeletal (Conventional)Musculo-skeletal (Superficial)Cardiac AdultCardiac PediatricPeripheral VesselNeedle guidance	OpthalmicFetal - OB/GYNAbdominalIntraoperative (abdominal organsand vascular)Intra-operative (Neuro.)PediatricSmall Organ (breast, thyroid,testicle, prostate)Neonatal CephalicAdult CephalicTrans-RectalTrans-VaginalMusculo-skeletal (Conventional)Musculo-skeletal (Superficial)Cardiac AdultCardiac PediatricTrans-esophageal (cardiac)Peripheral VesselNeedle guidance
TransducerTypes	Linear ArrayCurved Linear ArrayIntracavitaryPhased Array	Linear ArrayCurved Linear ArrayIntracavitaryPhased Array	Linear ArrayCurved Linear ArrayIntracavitaryPhased ArrayStatic ProbesTrans-esophageal
TransducerFrequency	1.0 – 15.0 MHz	1.0 - 15.0 MHz	1.0 - 15.0 MHz
Feature	SonoSite X-PorteUltrasound System(This submission)	SonoSite X-PorteUltrasound System(K133134)	SonoSite EdgeUltrasound System(K133454)
AcousticOutput Display& FDA Limits	$I_{STPA.3} ≤ 720 (mW/cm^2)$TI ≤ 4.0MI ≤1.9Display Feature for HigherOutputsMI Output DisplayTI Output Display	$I_{STPA.3} ≤ 720 (mW/cm^2)$TI ≤ 4.0MI ≤1.9Display Feature for HigherOutputsMI Output DisplayTI Output Display	$I_{STPA.3} ≤ 720 (mW/cm^2)$TI ≤ 4.0MI ≤1.9Display Feature for HigherOutputsMI Output DisplayTI Output Display
Modes ofOperation	B-mode Grayscale ImagingTissue Harmonic ImagingM-modeSimultaneous M-ModeColor Power DopplerZoomCombination ModesPulsed Wave (PW) DopplerContinuous Wave (CW) DopplerSonoHD2 Noise ReductionSonoMB/MBe ImageCompoundingSteered CW DopplerVelocity Color DopplerTissue Doppler Imaging (TDI)	B-mode Grayscale ImagingTissue Harmonic ImagingM-modeColor Power DopplerZoomCombination ModesPulsed Wave (PW) DopplerContinuous Wave (CW) DopplerSonoHD2 Noise ReductionSonoMB/MBe ImageCompoundingSteered CW DopplerVelocity Color DopplerTissue Doppler Imaging (TDI)	B-mode Grayscale ImagingTissue Harmonic ImagingM-modeColor M-ModeColor Power DopplerZoomCombination ModesPulsed Wave (PW) DopplerContinuous Wave (CW) DopplerSonoHD2 Noise ReductionSonoMB/MBe ImageCompoundingSteered CW DopplerVelocity Color DopplerTissue Doppler Imaging (TDI)
PW Doppler	Available	Available	Available
CW Doppler	Available	Available	Available
Velocity ColorDoppler	Available	Available	Available
Elastography(Strain), andStrain RateImaging	Not available	Not available	Available
ECG Feature	3-lead ECG input	3-lead ECG input	3-lead ECG input
DICOM	DICOM 3.0	DICOM 3.0	DICOM 3.0
IMTMeasurement	Not available	Not available	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)
PatientContactMaterials	Transducers:Acrylonitrile-butadien-styrene(ABS)CycoloyDow Medical Adhesive, Type AEpoxy paste adhesivePolysulfone UDEL P1700PolyurethanePoly-Vinyl-Chloride (PVC)Silicone RTV AdhesiveSilicone RubberUrethaneNeedle Guides:Acetal copolymerAcrylonitrile-butadien-styrene(ABS)	Transducers:Acrylonitrile-butadien-styrene(ABS)Dow Medical Adhesive, Type AEpoxy paste adhesivePolysulfone UDEL P1700PolyurethanePoly-Vinyl-Chloride (PVC)Silicone RubberUrethaneNeedle Guides:Acetal copolymerAcrylonitrile-butadien-styrene(ABS)	Transducers:Acrylonitrile-butadien-styrene(ABS)CycoloyDow Medical Adhesive, Type AEpoxy paste adhesivePolysulfone UDEL P1700PolyurethanePoly-Vinyl-Chloride (PVC)Silicone RTV AdhesiveSilicone RubberUrethaneNeedle Guides:Acetal copolymerAcrylonitrile-butadien-styrene(ABS)
SystemCharacteristics	X-Porte (stand configuration):Beamformer 128/128 using SA(configurable)12.1" Capacitive touch screen	X-Porte (stand configuration):Beamformer 128/128 using SA(configurable)12.1" Capacitive touch screen	Edge:Beamformer 128/128 using SA(configurable)Hand held display and control
Feature	SonoSite X-PorteUltrasound System(This submission)	SonoSite X-PorteUltrasound System(K133134)	SonoSite EdgeUltrasound System(K133454)
	19" LED LCD HD monitor256 gray shades on LED LCD	19" LED LCD HD monitor256 gray shades on LED LCD	(LCD)256 gray shades on LCD
	6 USB 2.0 ports	6 USB 2.0 ports	2 USB ports
	Stand Base Dimensions: 26.4" L x21.2" WStand Height (max): 64" (monitorup)Stand Height (min): 42.2" (monitordown)	Stand Base Dimensions: 26.4" L x21.2" WStand Height (max): 64" (monitorup)Stand Height (min): 42.2" (monitordown)	Dimensions: 12.9"(W) x 12.4 (L) x2.5"(H)
	Weight: 149.35 lbs (fullyconfigured w/ 3 transducers	Weight: 149.35 lbs (fullyconfigured w/ 3 transducers	Weight: 8.5 lbsBattery operated (1.5 - 4 houroperation per charge)
	System operates via battery or ACpower	System operates via battery or ACpower	System operates via battery or ACpower
	Battery life: 1 hour operational - 3days idle	Battery life: 1 hour operational - 3days idle	100 - 240V options, 50/60 Hz,15VDC output
	Input: 100 – 240 VAC, 50/60 HzOutput 1: 24VDC output, 275 WmaxOutput 2: 100-240VAC, 50-60 Hz(AC Printer)	Input: 100 – 240 VAC, 50/60 HzOutput 1: 24VDC output, 275 WmaxOutput 2: 100-240VAC, 50-60 Hz(AC Printer)	Various obstetrical, cardiac,volume, M-mode, PW and CWDoppler measurement andcalculation packages
	Various obstetrical, cardiac,volume, M-mode, PW and CWDoppler measurement andcalculation packages	Various obstetrical, cardiac,volume, M-mode, PW and CWDoppler measurement andcalculation packages	ECG acquisition and displaycapabilitiesCW/PW Doppler AudioSpectral Doppler Audio and imagestorage on removable media
	ECG acquisition and displaycapabilitiesCW/PW Doppler AudioSpectral Doppler Audio and imagestorage on removable mediaMeasurement on RecalledImages.	ECG acquisition and displaycapabilitiesCW/PW Doppler AudioSpectral Doppler Audio and imagestorage on removable mediaMeasurement on RecalledImages.	Wireless 802.11 (a\b\g) support forimage transfer
	Wireless 802.11 (a/b/g/n) supportfor image transfer	Wireless 802.11 (a/b/g/n) supportfor image transfer
	X-Porte (desktop configuration):	X-Porte (desktop configuration):
	Same softwarefeatures/capabilities as the standconfiguration. Does not have thestand, touch panel interface, DVR,and mobile power unit.	Same softwarefeatures/capabilities as the standconfiguration. Does not have thestand, touch panel interface, DVR,and mobile power unit.
	Weight: 32.80 lbs (w/ 1transducer)	Weight: 32.80 lbs (w/ 1transducer)
	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