SonoSite X-Porte Ultrasound System
Device Facts
| Record ID | K171437 |
|---|---|
| Device Name | SonoSite X-Porte Ultrasound System |
| Applicant | FUJIFILM Sonosite, Inc. |
| Product Code | IYN · Radiology |
| Decision Date | Jun 12, 2017 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric, 3rd-Party Reviewed |
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.
Device Story
SonoSite X-Porte is a mobile, digital ultrasound system for diagnostic imaging and fluid flow analysis. It processes ultrasound signals from various transducers (linear, curved, phased, intracavitary, TEE) to produce real-time images. The system features a touchscreen interface and operates in two configurations: a stand-based unit (battery/AC) or a desktop unit (AC only). It supports multiple imaging modes including B-mode, M-mode, Color Doppler, PW/CW Doppler, and Tissue Harmonic Imaging. Used by physicians and healthcare professionals in clinical settings, it provides high-resolution visualization to assist in needle/catheter placement, peripheral nerve blocks, and general diagnostic evaluations. Output is displayed on an integrated HD monitor, aiding clinical decision-making through real-time anatomical and hemodynamic assessment.
Clinical Evidence
No clinical studies were required to support the determination of substantial equivalence. Evidence is based on bench testing, including electrical, thermal, mechanical, and EMC safety evaluations, biocompatibility testing, and acoustic output characterization.
Technological Characteristics
Digital beamformer (128 transmit/64 receive channels, 128 using synthetic aperture). Transducer frequency range: 1.0–15.0 MHz. Materials: ABS, Cycoloy, PEEK, Polysulfone UDEL P1700, Silicone, Polyurethane, PVC. Connectivity: Wireless 802.11 (a/b/g/n), USB 2.0, DICOM 3.0. Standards: IEC 60601-1, IEC 60601-2-37, IEC 62359, NEMA UD2-2004, ISO 10993-1.
Indications for Use
Indicated for 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.), and Peripheral Vessel imaging.
Regulatory Classification
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.
Predicate Devices
- SonoSite X-Porte Ultrasound System (K152209)
- SonoSite Edge Ultrasound System (K133454)
- SonoSite Edge II Ultrasound System (K162045)
Related Devices
- K142017 — X-PORTE ULTRASOUND SYSTEM · FUJIFILM Sonosite, Inc. · Aug 22, 2014
- K133134 — X-PORTE ULTRASOUND SYSTEM · FUJIFILM Sonosite, Inc. · Nov 4, 2013
- K152209 — FUJIFILM SonoSite X-Porte Ultrasound System · FUJIFILM Sonosite, Inc. · Aug 19, 2015
- K183235 — SonoSite SII Ultrasound System · FUJIFILM Sonosite, Inc. · Feb 7, 2019
- K112539 — CHISON DIGITAL ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, TRANSVAGINAL MICRO-CONVEX PROBE, TRANSRECTAL LINEAR PROBE · Leiker Regulatory & Quality Consulting · Jan 30, 2012
Submission Summary (Full Text)
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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)
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
| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size:16px">❌</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size:16px">❍</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
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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 human<br>body as follows: | | | | | | |
| Clinical Application | Mode of Operation | | | | | | |
| | B | M | PWD | CWD | Color<br>Doppler<br>(C) | Combined<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | P | P | P | | P | B+M; B+PWD; B+C;<br>(B+C)+PWD | 1-5 |
| Fetal | P | P | P | | P | B+M; B+PWD; B+C;<br>(B+C)+PWD | 1,2,5 |
| Abdominal | P | P | P | P | P | B+M; B+PWD; B+CWD;<br>B+C; (B+C)+PWD;<br>(B+C)+CWD | 1,2,5 |
| Intra-operative (Abdominal<br>organs and vascular) | | | | | | | |
| Intra-operative (Neuro.) | | | | | | | |
| Laparoscopic<br>Pediatric | P | P | P | | P | B+M; B+PWD; B+CWD;<br>B+C; (B+C)+PWD;<br>(B+C)+CWD | 1-5 |
| Small Organ (breast, thyroid,<br>testicles, prostate) | P | P | P | | P | B+M; B+PWD; B+C;<br>(B+C)+PWD | 1,4,5 |
| Neonatal Cephalic | P | P | P | | P | B+M; B+PWD; B+C;<br>(B+C)+PWD | 1,5 |
| Adult Cephalic | P | P | P | | P | B+M; B+PWD; B+C;<br>(B+C)+PWD | 1,5 |
| Trans-rectal | | | | | | | |
| Trans-vaginal | P | P | P | | P | B+M; B+PWD; B+C;<br>(B+C)+PWD | 1,5 |
| Trans-urethral | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | |
| Musculo-skel. (Convent.) | P | P | P | | P | B+M; B+PWD; B+C;<br>(B+C)+PWD | 1,2,4,5 |
| Musculo-skel. (Superfic.) | P | P | P | | P | B+M; B+PWD; B+C;<br>(B+C)+PWD | 1,4,5 |
| Intra-luminal | | | | | | | |
| Other (spec.) | | | | | | | |
| Cardiac Adult | P | P | P | P | P | B+M; B+PWD; B+CWD;<br>B+C; (B+C)+PWD;<br>(B+C)+CWD | 1-3 |
| Cardiac Pediatric | P | P | P | P | P | B+M; B+PWD; B+CWD;<br>B+C; (B+C)+PWD;<br>(B+C)+CWD | 1-3 |
| Trans-esophageal (card.) | P | P | P | P | P | B+M; B+PWD; B+CWD;<br>B+C; (B+C)+PWD;<br>(B+C)+CWD | 1,3 |
| Other (spec.) | | | | | | | |
| Peripheral vessel | P | P | P | | P | B+M; B+PWD; B+C;<br>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 | Color<br>Doppler<br>(C) | Combined<br>(Spec.) | Other<br>(Spec.) | | |
| Ophthalmic | | | | | | | | | |
| Fetal | P | P | P | | P | B+M; B+PWD; B+C;<br>(B+C)+PWD | 1,5 | | |
| Abdominal | P | P | P | | P | B+M; B+PWD; B+C;<br>(B+C)+PWD | 1,5 | | |
| Intra-operative (Abdominal<br>organs and vascular) | | | | | | | | | |
| Intra-operative (Neuro.) | | | | | | | | | |
| Laparoscopic | P | P | P | | P | B+M; B+PWD; B+C;<br>(B+C)+PWD | 1,5 | | |
| Pediatric | | | | | | | | | |
| Small Organ (breast, thyroid,<br>testicles. prostate) | P | P | P | | P | B+M; B+PWD; B+C;<br>(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;<br>(B+C)+PWD | 1,5 | | |
| Cardiac Pediatric | | | | | | | | | |
| Trans-esophageal (card.) | | | | | | | | | |
| Other (spec.) | | | | | | | | | |
| Peripheral vessel | P | P | P | | P | B+M; B+PWD; B+C;<br>(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 human<br>body as follows: | | | | | | |
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler<br>(C) | Combined<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | | | | | | | |
| Fetal | | | | | | | |
| Abdominal | P | P | P | | P | B+M; B+PWD; B+C;<br>(B+C)+PWD | 1,2,5 |
| Intra-operative (Abdominal<br>organs and vascular) | | | | | | | |
| Intra-operative (Neuro.) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | P | P | P | | P | B+M; B+PWD; B+C;<br>(B+C)+PWD | 1,2,4,5 |
| Small Organ (breast, thyroid,<br>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;<br>(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;<br>(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 human<br>body as follows: | | | | | | |
| Clinical Application | Mode of Operation | | | | | | |
| | B | M | PWD | CWD | Color<br>Doppler<br>(C) | Combined<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | P | P | P | P | P | B+M; B+PWD; B+C;<br>(B+C)+PWD | 1,2,5 |
| Fetal | P | P | P | P | P | B+M; B+PWD; B+C;<br>(B+C)+PWD | 1,2,5 |
| Abdominal | | | | | | | |
| Intra-operative (Abdominal<br>organs and vascular) | | | | | | | |
| Intra-operative (Neuro.) | | | | | | | |
| Laparoscopic | P | P | P | P | P | B+M; B+PWD; B+C;<br>(B+C)+PWD | 1,2,4,5 |
| Pediatric | | | | | | | |
| Small Organ (breast, thyroid,<br>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;<br>(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;<br>(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:
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) 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 human<br>body as follows: | | | | | | |
| Clinical Application | Mode of Operation | | | | | | |
| | B | M | PWD | CWD | Color<br>Doppler<br>(C) | Combined<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | | | | | | | |
| Fetal | | | | | | | |
| Abdominal | | | | | | | |
| Intra-operative (Abdominal<br>organs and vascular) | | | | | | | |
| Intra-operative (Neuro.) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | | | | | | | |
| Small Organ (breast, thyroid,<br>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:
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 "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 human<br>body as follows: | | | | | | |
| Clinical Application | | Mode of Operation | | | | | |
| | B | M | PWD | Color<br>Doppler<br>(C) | Combined<br>(Spec.) | Other<br>(Spec.) | |
| Ophthalmic | | | | | | | |
| Fetal | P | P | P | P | B+M; B+PWD; B+C;<br>(B+C)+PWD | 1,4,5 | |
| Abdominal | P | P | P | P | B+M; B+PWD; B+C;<br>(B+C)+PWD | 1,4,5 | |
| Intra-operative (Abdominal<br>organs and vascular) | | | | | | | |
| Intra-operative (Neuro.) | | | | | | | |
| Laparoscopic | P | P | P | P | B+M; B+PWD; B+C;<br>(B+C)+PWD | 1,4,5 | |
| Pediatric | P | P | P | P | B+M; B+PWD; B+C;<br>(B+C)+PWD | 1,4,5 | |
| Small Organ (breast, thyroid,<br>testicles. prostate) | P | P | P | P | B+M; B+PWD; B+C;<br>(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;<br>(B+C)+PWD | 1,4,5 | |
| Musculo-skel. (Convent.) | P | P | P | P | B+M; B+PWD; B+C;<br>(B+C)+PWD | 1,4,5 | |
| Musculo-skel. (Superfic.) | P | P | P | P | B+M; B+PWD; B+C;<br>(B+C)+PWD | 1,4,5 | |
| Intra-luminal | | | | | | | |
| Other (spec.) | | | | | | | |
| Cardiac Adult | P | P | P | P | B+M; B+PWD; B+C;<br>(B+C)+PWD | 1,5 | |
| Cardiac Pediatric | P | P | P | P | B+M; B+PWD; B+C;<br>(B+C)+PWD | 1,5 | |
| Trans-esophageal (card.) | | | | | | | |
| Other (spec.) | | | | | | | |
| Peripheral vessel | P | P | P | P | B+M; B+PWD; B+C;<br>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:
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) K152209 and K142017.
{9}------------------------------------------------
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 human<br>body as follows: | | | | | | |
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler<br>(C) | Combined<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | | | | | | | |
| Fetal | P | P | P | | P | B+M; B+PWD; B+C;<br>(B+C)+PWD | 1,4,5 |
| Abdominal | | | | | | | |
| Intra-operative (Abdominal<br>organs and vascular) | | | | | | | |
| Intra-operative (Neuro.) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | P | P | P | | P | B+M; B+PWD; B+C;<br>(B+C)+PWD | 1,4,5 |
| Small Organ (breast, thyroid,<br>testicles. prostate) | P | P | P | | P | B+M; B+PWD; B+C;<br>(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;<br>(B+C)+PWD | 1,4,5 |
| Musculo-skel. (Convent.) | P | P | P | | P | B+M; B+PWD; B+C;<br>(B+C)+PWD | 1,4,5 |
| Musculo-skel. (Superfic.) | P | P | P | | P | B+M; B+PWD; B+C;<br>(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;<br>(B+C)+PWD | 1,4,5 |
| Other (spec.) | | | | | | | |
#### 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) K133134.
{10}------------------------------------------------
| 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 human<br>body as follows: | | | | | | | |
| Clinical Application | | Mode of Operation | | | | | | |
| | B | M | PWD | CWD | Color<br>Doppler<br>(C) | Combined<br>(Spec.) | Other<br>(Spec.) | |
| Ophthalmic | P | P | P | | P | B+M; B+PWD; B+C;<br>(B+C)+PWD | 1,4,5 | |
| Fetal | P | P | P | | P | B+M; B+PWD; B+C;<br>(B+C)+PWD | 1,4,5 | |
| Abdominal | P | P | P | | P | B+M; B+PWD; B+C;<br>(B+C)+PWD | 1,4,5 | |
| Intra-operative (Abdominal<br>organs and vascular) | | | | | | | | |
| Intra-operative (Neuro.) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Pediatric | P | P | P | | P | B+M; B+PWD; B+C;<br>(B+C)+PWD | 1,4,5 | |
| Small Organ (breast, thyroid,<br>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;<br>(B+C)+PWD | 1,4,5 | |
| Musculo-skel. (Convent.) | P | P | P | | P | B+M; B+PWD; B+C;<br>(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;<br>(B+C)+PWD | 1,5 | |
| Cardiac Pediatric | P | P | P | | P | B+M; B+PWD; B+C;<br>(B+C)+PWD | 1,5 | |
| Trans-esophageal (card.) | | | | | | | | |
| Other (spec.) | | | | | | | | |
| Peripheral vessel | P | P | P | | P | B+M; B+PWD; B+C;<br>(B+C)+PWD | 1,4,5,6 | |
| Other (spec.) | | | | | | | | |
#### 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.
{11}------------------------------------------------
| System: | SonoSite X-Porte Ultrasound System | | | | | | | |
|-------------------------------------------------------|---------------------------------------------------------------------------------------|-------------------|-----|-----|-------------------------|-------------------------------|------------------|--|
| Transducer: | ICTxp/9-5 MHz Transducer | | | | | | | |
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human<br>body as follows: | | | | | | | |
| Clinical Application | | Mode of Operation | | | | | | |
| | B | M | PWD | CWD | Color<br>Doppler<br>(C) | Combined<br>(Spec.) | Other<br>(Spec.) | |
| Ophthalmic | P | P | P | | P | B+M; B+PWD; B+C;<br>(B+C)+PWD | 1,5 | |
| Fetal | P | P | P | | P | B+M; B+PWD; B+C;<br>(B+C)+PWD | 1,5 | |
| Abdominal | | | | | | | | |
| Intra-operative (Abdominal<br>organs and vascular) | | | | | | | | |
| Intra-operative (Neuro.) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Pediatric | | | | | | | | |
| Small Organ (breast, thyroid,<br>testicles, prostate) | | | | | | | | |
| Neonatal Cephalic | | | | | | | | |
| Adult Cephalic | | | | | | | | |
| Trans-rectal | P | P | P | | P | B+M; B+PWD; B+C;<br>(B+C)+PWD | 1,5 | |
| Trans-vaginal | P | P | P | | P | B+M; B+PWD; B+C;<br>(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:
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) K133134.
{12}------------------------------------------------
| System: | SonoSite X-Porte Ultrasound System | | | | | | | |
|-------------------------------------------------------|--------------------------------------------------------------…
