Who is the manufacturer of X-PORTE ULTRASOUND SYSTEM?

FUJIFILM Sonosite, Inc. filed the 510(k) submission for X-PORTE ULTRASOUND SYSTEM (K142017).

What is the FDA product code for X-PORTE ULTRASOUND SYSTEM?

IYN. It is classified under 21 CFR 892.1550 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for X-PORTE ULTRASOUND SYSTEM?

510(k) clearance (submission type: Traditional).

What are the predicate devices for X-PORTE ULTRASOUND SYSTEM?

SonoSite X-Porte Ultrasound System (K133134); SonoSite Edge Ultrasound System (K133454).

Who can help prepare an FDA 510(k) submission like X-PORTE ULTRASOUND SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

X-PORTE ULTRASOUND SYSTEM

K142017 · FUJIFILM Sonosite, Inc. · IYN · Aug 22, 2014 · Radiology

Device Facts

Record ID	K142017
Device Name	X-PORTE ULTRASOUND SYSTEM
Applicant	FUJIFILM Sonosite, Inc.
Product Code	IYN · Radiology
Decision Date	Aug 22, 2014
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 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 Story

Mobile, full-featured ultrasound system; acquires/displays high-resolution, real-time ultrasound data. Custom digital electronic design; configurable for specific applications via feature selection. Interface: backlit touchscreen (tablet-like). Configurations: stand-based (AC/battery) or desktop (AC only). Desktop mode: engine removable from stand, used with single transducer and external monitor. Operates via multiple imaging modes (B-mode, M-mode, Doppler, etc.). Healthcare providers use output for diagnostic imaging and fluid flow analysis; aids in needle/catheter placement and peripheral nerve blocks. Benefits: high-resolution visualization for clinical decision-making in various settings.

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, biocompatibility, and acoustic output characterization.

Technological Characteristics

Digital ultrasound system; 128 transmit/receive channels (128 using synthetic aperture). Materials: ABS, Cycoloy, Dow Medical Adhesive, epoxy, polysulfone UDEL P1700, polyurethane, PVC, silicone RTV, silicone rubber, urethane, acetal copolymer. Modes: B-mode, THI, M-mode, Color Power/Velocity Doppler, PW/CW Doppler, SonoHD2, SonoMB/MBe. Connectivity: DICOM 3.0, USB 2.0, 802.11 a/b/g/n. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62359, ISO 10993-1.

Indications for Use

Indicated for qualified physicians to perform ultrasound imaging or fluid flow analysis of the human body, including ophthalmic, fetal/OB/GYN, abdominal, intra-operative (abdominal/vascular), pediatric, small organ (breast, thyroid, testicles, prostate), neonatal/adult cephalic, trans-vaginal, musculoskeletal (conventional/superficial), cardiac (adult/pediatric), and peripheral vessel applications. Includes needle guidance.

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 (K133134)
SonoSite Edge Ultrasound System (K133454)

Related Devices

K152209 — FUJIFILM SonoSite X-Porte Ultrasound System · FUJIFILM Sonosite, Inc. · Aug 19, 2015
K133134 — X-PORTE ULTRASOUND SYSTEM · FUJIFILM Sonosite, Inc. · Nov 4, 2013
K201633 — Terason uSmart 3200T Plus Ultrasound System · Teratech Corporation · Jul 2, 2020
K171437 — SonoSite X-Porte Ultrasound System · FUJIFILM Sonosite, Inc. · Jun 12, 2017
K113156 — SONOSITE EDGE ULTRASOUND SYSTEM · Sonosite,Inc. · Nov 15, 2011

Submission Summary (Full Text)

{0}------------------------------------------------ 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) TBD K142017 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 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 | Type of Use (Select one or both, as applicable) | <div style="display:inline-block; vertical-align:middle;"> <svg height="16px" width="16px"> <path d="M2 2h12v12H2z" fill="none" stroke="black" stroke-width="2"></path> <path d="M4 4l8 8M4 12l8-8" stroke="black" stroke-width="2"></path> </svg> </div> Prescription Use (Part 21 CFR 801 Subpart D) | <div style="display:inline-block; vertical-align:middle;"> <svg height="16px" width="16px"> <path d="M2 2h12v12H2z" fill="none" stroke="black" stroke-width="2"></path> </svg> </div> 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) {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 body as follows: | | | | | | | | Clinical Application | B | M | PWD | CWD | Color Doppler | 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 (Abdominal 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+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) {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 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: 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 Prescription Use (Per 21 CFR 801.109) Page 3 of 13 {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 | | | | | | | | | | | 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 | 1,2,5 | | | 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: 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 Prescription Use (Per 21 CFR 801.109) Page 4 of 13 {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 | | | | | | | | | 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 (Abdominal organs 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: 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 5 of 13 {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 | | | | | Other (Spec.) | | | | B | M | PWD | CWD | Color Doppler | Combined (Spec.) | | | Ophthalmic | | | | | | | | | Fetal | | | | | | | | | Abdominal | E | E | E | | E | B+M; B+PWD; B+CD | 1,4,5 | | Intra-operative (Abdominal organs 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: 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 Prescription Use (Per 21 CFR 801.109) Page 6 of 13 {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 body 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: 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 13 {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 | | | | | | | | | | | | 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: 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 Prescription Use (Per 21 CFR 801.109) Page 8 of 13 {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 13 {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 body as follows: | | | | | | | | Clinical Application | B | M | PWD | CWD | Color Doppler | 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 (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 1.3-9: 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) K133134. Prescription Use (Per 21 CFR 801.109) Page 10 of 13 {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 | 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.) | | | |…