FUJIFILM SonoSite X-Porte Ultrasound System
Device Facts
| Record ID | K152209 |
|---|---|
| Device Name | FUJIFILM SonoSite X-Porte Ultrasound System |
| Applicant | FUJIFILM Sonosite, Inc. |
| Product Code | IYN · Radiology |
| Decision Date | Aug 19, 2015 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric, 3rd-Party Reviewed |
Intended Use
The FUJIFILM 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 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 Trans-esophageal (card.) Peripheral Vessel
Device Story
Mobile, full-featured ultrasound system; acquires/displays high-resolution, real-time ultrasound data. Custom digital design; configurable for specific imaging applications. Operates in stand-based (AC/battery) or desktop (AC only) configurations. Interface uses backlit touchscreen. Input: ultrasound signals via various transducers (linear, curved, phased array, intracavitary, trans-esophageal). Output: real-time images/fluid flow analysis on integrated LED LCD monitor. Used in clinical settings by physicians/healthcare professionals. Output assists in diagnosis, needle/catheter placement, and peripheral nerve block guidance. Benefits include high-resolution imaging for diverse clinical applications.
Clinical Evidence
No clinical data required; substantial equivalence supported by bench testing, including electrical, thermal, mechanical, and EMC safety, biocompatibility, and acoustic output characterization.
Technological Characteristics
Digital beamformer (128/128 channels using synthetic aperture). Transducers: linear, curved, phased array, intracavitary, trans-esophageal (1.0-15.0 MHz). Materials: ABS, Cycoloy, PEEK, polysulfone, silicone, polyurethane. Connectivity: DICOM 3.0, 802.11 (a/b/g/n) wireless. Power: AC or battery. Safety standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62359, ISO 10993-1.
Indications for Use
Indicated for qualified physicians and healthcare professionals for ultrasound imaging or fluid flow analysis of the human body, including ophthalmic, fetal, OB/GYN, abdominal, intra-operative, pediatric, small organ, neonatal/adult cephalic, trans-vaginal, musculoskeletal, cardiac, and peripheral vessel applications.
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 (K142017)
- SonoSite Edge Ultrasound System (K133454)
Related Devices
- K142017 — X-PORTE ULTRASOUND SYSTEM · FUJIFILM Sonosite, Inc. · Aug 22, 2014
- K133134 — X-PORTE ULTRASOUND SYSTEM · FUJIFILM Sonosite, Inc. · Nov 4, 2013
- K122387 — VOLUSON P6, VOLUSON P8 · GE Healthcare · Sep 11, 2012
- K153626 — SonoSite Edge II Ultrasound System · FUJIFILM Sonosite, Inc. · Jan 20, 2016
- K210743 — ACUSON Redwood Diagnostic Ultrasound System · Siemens Medical Solutions USA, Inc. · Apr 1, 2021
Submission Summary (Full Text)
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 19, 2015
Fujifilm Sonosite, Inc. % Mark Job Responsible Third Party Official 1394 25th Street, NW BUFFALO MN 55313
Re: K152209
Trade/Device Name: FUJIFILM 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: July 21, 2015 Received: August 7, 2015
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
{1}------------------------------------------------
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D'Hara For
Robert Ochs Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
# Indications for Use
510(k) Number (if known) TBD
#### Device Name
FUJIFILM SonoSite X-Porte Ultrasound System
#### Indications for Use (Describe)
The FUJIFILM 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 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 Trans-esophageal (card.) Peripheral Vessel
Type of Use (Select one or both, as applicable)
| <span style="font-family: sans-serif;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-family: sans-serif;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
# CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
# *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
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 human<br>body as follows: | | | | | | | |
| Clinical Application | Mode of Operation | | | | | | | |
| | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Spec.) | Other<br>(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;<br>B+CWD; B+CD | 1-5 | |
| Intra-operative (Abdominal<br>organs and vascular) | P | P | P | | P | B+M; B+PWD; B+CD | 1-5 | |
| Intra-operative (Neuro.)<br>Laparoscopic | | | | | | | | |
| Pediatric | P | P | P | | P | B+M; B+PWD;<br>B+CWD; B+CD | 1-5 | |
| Small Organ (breast, thyroid,<br>testicles, prostate) | P | P | P | | P | B+M; B+PWD; B+CD | 1-5 | |
| Neonatal Cephalic | P | P | P | | P | B+M; B+PWD; B+CD | 1-3,5 | |
| Adult Cephalic | P | P | P | | P | B+M; B+PWD; B+CD | 1-3,5 | |
| Trans-rectal | | | | | | | | |
| 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;<br>B+CWD; B+CD | 1-5 | |
| Cardiac Pediatric | P | P | P | P | P | B+M; B+PWD;<br>B+CWD; B+CD | 1-5 | |
| Trans-esophageal (card.) | N | N | N | N | N | B+M; B+PWD;<br>B+CWD; B+CD | 1,3,5 | |
| 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) K142017 and K133134.
{4}------------------------------------------------
| 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<br>Doppler | Combined<br>(Spec.) | Other<br>(Spec.) | |
| Ophthalmic | | | | | | | | |
| Fetal | | | | | | | | |
| Abdominal | P | P | P | | P | B+M; B+PWD; B+CD | 1,5 | |
| Intra-operative (Abdominal<br>organs 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+CD | 1,5 | |
| Small Organ (breast, thyroid,<br>testicles. prostate) | P | P | P | | P | B+M; B+PWD; B+CD | 1,5 | |
| Neonatal Cephalic | P | P | P | | P | B+M; B+PWD; B+CD | 1,5 | |
| Adult Cephalic | | | | | | | | |
| Trans-rectal | | | | | | | | |
| Trans-vaginal | | | | | | | | |
| Trans-urethral | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | |
| Musculo-skel. (Convent.) | | | | | | | | |
| Musculo-skel. (Superfic.) | | | | | | | | |
| Intra-luminal | | | | | | | | |
| Other (spec.) | | | | | | | | |
| Cardiac Adult | | | | | | | | |
| Cardiac Pediatric | P | P | P | | P | B+M; B+PWD; B+CD | 1,5 | |
| Trans-esophageal (card.) | | | | | | | | |
| Other (spec.) | | | | | | | | |
| Peripheral vessel | P | P | P | | P | B+M; B+PWD; B+CD | 1,5 | |
| Other (spec.) | | | | | | | | |
Table 1.3-2: 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:
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) K142017.
{5}------------------------------------------------
| 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<br>body as follows: | | | | | | | |
| Clinical Application | Mode of Operation | | | | | | | Other<br>(Spec.) |
| | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Spec.) | | |
| Ophthalmic | | | | | | | | |
| Fetal | | | | | | | | |
| Abdominal | P | P | P | | P | B+M; B+PWD; B+CD | 1,2,4,5 | |
| Intra-operative (Abdominal<br>organs and vascular) | P | P | P | | P | B+M; B+PWD; B+CD | 1,2,4,5 | |
| Intra-operative (Neuro.) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Pediatric | P | P | P | | P | B+M; B+PWD; B+CD | 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+CD | 1,2,4,5 | |
| Musculo-skel. (Superfic.) | | | | | | | | |
| Intra-luminal | | | | | | | | |
| Other (spec.) | | | | | | | | |
| Cardiac Adult | | | | | | | | |
| Cardiac Pediatric | | | | | | | | |
| Trans-esophageal (card.) | | | | | | | | |
| Other (spec.) | | | | | | | | |
| Peripheral vessel | P | P | P | | P | B+M; B+PWD; B+CD | 1,2,4,5 | |
| Other (spec.) | | | | | | | | |
Table 1.3-3: 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:
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) K142017.
{6}------------------------------------------------
| System: | FUJIFILM SonoSite X-Porte Ultrasound System | | | | | | |
|----------------------------------------------------|------------------------------------------------------------------------------------|---|-----|-----|---------------|------------------|---------------|
| Transducer: | C60xp/5-2 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 | P | P | P | | P | B+M; B+PWD; B+CD | 1,2,5 |
| Fetal | P | P | P | | P | B+M; B+PWD; B+CD | 1,2,4,5 |
| Abdominal | P | P | P | | P | B+M; B+PWD; B+CD | 1,2,4,5 |
| Intra-operative (Abdominal organs and vascular) | P | P | P | | P | B+M; B+PWD; B+CD | 1,2,4,5 |
| Intra-operative (Neuro.) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | P | P | P | | P | B+M; B+PWD; B+CD | 1,2,4,5 |
| Small Organ (breast, thyroid, testicles, prostate) | | | | | | | |
| Neonatal Cephalic | | | | | | | |
| Adult Cephalic | | | | | | | |
| Trans-rectal | | | | | | | |
| Trans-vaginal | | | | | | | |
| Trans-urethral | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | |
| Musculo-skel. (Convent.) | P | P | P | | P | B+M; B+PWD; B+CD | 1,2,4,5 |
| Musculo-skel. (Superfic.) | | | | | | | |
| Intra-luminal | | | | | | | |
| Other (spec.) | | | | | | | |
| Cardiac Adult | | | | | | | |
| Cardiac Pediatric | | | | | | | |
| Trans-esophageal (card.) | | | | | | | |
| Other (spec.) | | | | | | | |
| Peripheral vessel | P | P | P | | P | B+M; B+PWD; B+CD | 1,2,4,5 |
| Other (spec.) | | | | | | | |
Table 1.3-4: 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:
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.
{7}------------------------------------------------
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 human | | | | | | | |
| | body as follows: | | | | | | | |
| Clinical Application | Mode of Operation | | | | | | | |
| | | Color<br>Combined<br>Other | | | | | | |
| | B | M | PWD | CWD | Doppler | (Spec.) | (Spec.) | |
| Ophthalmic | | | | | | | | |
| Fetal | | | | | | | | |
| Abdominal | P | P | P | | P | B+M; B+PWD; B+CD | 1,4,5 | |
| Intra-operative (Abdominal | P | P | P | | P | B+M; B+PWD; B+CD | 1,4,5 | |
| organs and vascular) | | | | | | | | |
| Intra-operative (Neuro.) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Pediatric | P | P | P | | P | B+M; B+PWD; B+CD | 1,4,5 | |
| Small Organ (breast, thyroid, | P | P | P | | P | 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.) | 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.) | | | | | | | | |
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) K142017.
Prescription Use (Per 21 CFR 801.109)
Page 6 of 14
{8}------------------------------------------------
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 human<br>body as follows: | | | | | | |
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | | | | | | | |
| Fetal | | | | | | | |
| Abdominal | P | P | P | | P | B+M; B+PWD; B+CD | 1,4,5 |
| Intra-operative (Abdominal<br>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,<br>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:
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)
Page 7 of 14
{9}------------------------------------------------
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<br>body as follows: | | | | | | |
| Clinical Application | | | | | | Mode of Operation | |
| | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | P | P | P | | P | B+M; B+PWD; B+CD | 1,4,5 |
| Fetal | | | | | | | |
| Abdominal | P | P | P | | P | B+M; B+PWD; B+CD | 1,4,5 |
| Intra-operative (Abdominal<br>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,<br>testicles. prostate) | P | P | P | | P | B+M; B+PWD; B+CD | 1,4,5 |
| Neonatal Cephalic | | | | | | | |
| Adult Cephalic | | | | | | | |
| Trans-rectal | | | | | | | |
| Trans-vaginal | | | | | | | |
| Trans-urethral | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | |
| Musculo-skel. (Convent.) | P | P | P | | P | B+M; B+PWD; B+CD | 1,4,5 |
| Musculo-skel. (Superfic.) | P | P | P | | P | B+M; B+PWD; B+CD | 1,4,5 |
| Intra-luminal | | | | | | | |
| Other (spec.) | | | | | | | |
| Cardiac Adult | P | P | P | | P | B+M; B+PWD; B+CD | 1,4,5 |
| Cardiac Pediatric | P | P | P | | P | B+M; B+PWD; B+CD | 1,4,5 |
| Trans-esophageal (card.) | | | | | | | |
| Other (spec.) | | | | | | | |
| Peripheral vessel | P | P | P | | P | B+M; B+PWD; B+CD | 1,4,5 |
| Other (spec.) | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under this appendix
#### Additional Comments:
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) K142017.
Prescription Use (Per 21 CFR 801.109)
Page 8 of 14
{10}------------------------------------------------
| 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:
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)
Page 9 of 14
{11}------------------------------------------------
| System: | FUJIFILM SonoSite X-Porte Ultrasound System | | | | | | |
|-------------------------------------------------------|---------------------------------------------------------------------------------------|---|-----|-----|------------------|---------------------|------------------|
| Transducer: | L25xp/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 | Combined<br>(Spec.) | Other<br>(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 (Abdominal<br>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,<br>testicles, prostate) | P | P | P | | P | B+M; B+PWD; B+CD | 1,4,5 |
| Neonatal Cephalic | | | | | | | |
| Adult Cephalic | | | | | | | |
| Trans-rectal | | | | | | | |
| Trans-vaginal | | | | | | | |
| Trans-urethral | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | |
| Musculo-skel. (Convent.) | P | P | P | | P | B+M; B+PWD; B+CD | 1,4,5 |
| Musculo-skel. (Superfic.) | P | P | P | | P | B+M; B+PWD; B+CD | 1,4,5 |
| Intra-luminal | | | | | | | |
| Other (spec.) | | | | | | | |
| Cardiac Adult | P | P | P | | P | B+M; B+PWD; B+CD | 1,4,5 |
| Cardiac Pediatric | P | P | P | | P | B+M; B+PWD; B+CD | 1,4,5 |
| Trans-esophageal (card.) | | | | | | | |
| Other (spec.) | | | | | | | |
| Peripheral vessel | P | P | P | | P | B+M; B+PWD; B+CD | 1,4,5 |
| Other (spec.) | | | | | | | |
Table 1.3-9: 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:
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) K142017 and K133134.
Prescription Use (Per 21 CFR 801.109)
Page 10 of 14
{12}------------------------------------------------
| 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 | P | P | P | | P | B+M; B+PWD; B+CD | 1,4,5 | |
| Cardiac Pediatric | P | P | P | | P | B+M; B+PWD; B+CD | 1,4,5 | |
| Trans-esophageal (card.) | | | | | | | | |
| Other (spec.) | | | | | | | | |
| Peripheral vessel | P | P | P | | P | B+M; B+PWD; B+CD | 1,4,5 | |
| Other (spec.) | | | | | | | | |
Table 1.3-10: Diagnostic Ultrasound Indications for Use Form – L38xp/10-5 Transducer
N= new indication; P= previously cleared by FDA; E= added under this appendix
#### Additional Comments:
1: Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for peripheral nerve block procedures. Color Doppler includes Power/Velocity/Variance. M-Mode includes 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) K142017 and K133134.
Prescription Use (Per 21 CFR 801.109)
Page 11 of 14
{13}------------------------------------------------
| System: | FUJIFILM SonoSite X-Porte Ultrasound System | | | | | | |
|-------------------------------------------------------|---------------------------------------------------------------------------------------|---|-----|-----|---------------|-------------------------|---------------|
| Transducer: | P10xp/8-4 MHz Transducer…
