(34 days)
Not Found
No
The document does not mention AI, ML, or related terms, and the description focuses on standard ultrasound technology and features.
No
The device is described as an "ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body," which indicates a diagnostic rather than therapeutic purpose.
Yes
The device is an ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body, providing data to aid in diagnosis.
No
The device description explicitly states it is a "general purposic ultrasound system" and a "custom fabricated digital electronic design" that acquires and displays real-time ultrasound data. This indicates it includes hardware components beyond just software.
Based on the provided information, the FUJIFILM SonoSite X-Porte Ultrasound System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the system is for "evaluation by ultrasound imaging or fluid flow analysis of the human body." This involves imaging within the body, not testing samples outside the body (in vitro).
- Device Description: The description details a system that acquires and displays real-time ultrasound data from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples outside of the body, which are hallmarks of IVD devices.
Therefore, the device is a medical imaging system used for diagnostic purposes in vivo (within the living body), not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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) Trans-vaginal Musculo-skel. (Convent.) Musculo-skel. (Superfic.) Cardiac Adult Cardiac Pediatric Peripheral vessel
Product codes
90-IYN, 90-IYO, 90-ITX
Device Description
The SonoSite X-Porte Ultrasound System is a highly mobile, full featured, general purposic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. X-Porte is a custom fabricated digital electronic design that readly lends itself to be configured for specific ultrasound imaging applications through different system feature selections. The system interface can be customized for the user and controlled using a backlit touchscreen much like what is used in consumer tablet products. X-Porte can be operated in two different configurations, standbased with AC power or battery, and desktop-based with AC power only. In desktop configuration the ultrasound engine can be removed from the stand and used by itself with a single transducer and external monitor.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Ophthalmic, Fetal - OB/GYN, Abdominal, Intra-operative (Abdominal organs and vascular), Pediatric, Small Organ (breast, thyroid, testicles, prostate), Trans-vaginal, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Cardiac Adult, Cardiac Pediatric, Peripheral vessel
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The SonoSite X-Porte Ultrasound System and transducers, subject of this submission, did not reguire clinical studies to support the determination of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
K133134
Page 1 of 5
510(K) Summary
This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with 21 CFR, Part 807, Subpart E, Section 807.92.
1) Submitter's name, address, telephone number, contact person:
FUJIFILM SonoSite, Inc. 21919 30th Drive SE Bothell, WA 98021-3904
Corresponding Official:
E-mail: Telephone: Facsimile: Date prepared: Scott E. Paulson Sr. Manager, Regulatory Affairs Scott.Paulson@sonosite.com (425) 951-6926 (425) 491-8356 September 9, 2013
NOV 04 2013
- Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known:
Common/ Usual Name
Diagnostic Ultrasound System with Accessories
Proprietary Name
SonoSite X-Porte™ Ultrasound System (subject to change)
Classification Names
| Name | FR Number | Product Code |
|---|---|---|
| Ultrasonic Pulsed Doppler Imaging System | 892.1550 | 90-IYN |
| Ultrasonic Pulsed Echo Imaging System | 892.1560 | 90-IYO |
| Diagnostic Ultrasound Transducer | 892.1570 | 90-ITX |
3) Identification of the predicate or legally marketed device:
SonoSite Edge Ultrasound System K113156
4) Device Description:
The SonoSite X-Porte Ultrasound System is a highly mobile, full featured, general purposic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. X-Porte is a custom fabricated digital electronic design that readly lends itself to be configured for specific ultrasound imaging applications through different system feature selections. The system interface can be customized for the user and controlled using a backlit touchscreen much like what is used in consumer tablet products. X-Porte can be operated in two different configurations, standbased with AC power or battery, and desktop-based with AC power only. In desktop configuration the ultrasound engine can be removed from the stand and used by itself with a single transducer and external monitor.
1
5) 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) Trans-vaginal Musculo-skel. (Convent.) Musculo-skel. (Superfic.) Cardiac Adult Cardiac Pediatric Peripheral vessel
6) Technological Characteristics:
SonoSite X-Porte and Edge Ultrasound Systems are both Track 3 devices that employ the same fundamental scientific technology. A comparison table is provided below.
| Feature | SonoSite X-Porte Ultrasound
System
(this submission) | SonoSite Edge Ultrasound System
(K113156) |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Diagnostic ultrasound imaging or fluid flow
analysis of the human body | Diagnostic ultrasound imaging or fluid flow
analysis of the human body |
| Indications for Use | Opthalmic
Fetal - OB/GYN
Abdominal
Intraoperative (abdominal organs and
vascular)
Pediatric
Small Organ (breast, thyroid, testicle, prostate)
Trans-Vaginal
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Cardiac Adult
Cardiac Pediatric | Opthalmic
Fetal - OB/GYN
Abdominal
Intraoperative (abdominal organs and
vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric
Small Organ (breast, thyroid, testicle, prostate)
Neonatal Cephalic
Adult Cephalic
Trans-Rectal
Trans-Vaginal
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Cardiac Adult
Cardiac Pediatric
Trans-esophageal (cardiac) |
| | Peripheral Vessel
Needle guidance | Peripheral Vessel
Needle guidance |
| Transducer Types | Linear Array
Curved Linear Array
Intracavitary
Phased Array | Linear Array
Curved Linear Array
Intracavitary
Phased Array
Static Probes
Trans-esophageal
Wobbler Probes |
| Transducer
Frequency | 1.0 - 15.0 MHz | 1.0 - 15.0 MHz |
2
| Feature | SonoSite X-Porte Ultrasound System
(this submission) | SonoSite Edge Ultrasound System
(K113156) | | | |
|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--------------|--------------|
| Acoustic Output Display & FDA Limits | Display Feature for Higher Outputs
MI Output Display
TI Output Display | Display Feature for Higher Outputs
MI Output Display
TI Output Display | | | |
| Modes of Operation | B-mode Grayscale Imaging
Tissue Harmonic Imaging
M-mode
Color M-Mode
Color Power Doppler
Zoom
Combination Modes
Pulsed Wave (PW) Doppler
Continuous Wave (CW) Doppler
SonoHD2 Noise Reduction
SonoMB/MBe Image Compounding
Steered CW Doppler
Velocity Color Doppler
Tissue Doppler Imaging (TDI) | B-mode Grayscale Imaging
3D/4D Grayscale Imaging
Tissue Harmonic Imaging
M-mode
Anatomical M-Mode
Color M-Mode
Color Power Doppler
Zoom
Combination Modes
Pulsed Wave (PW) Doppler
Continuous Wave (CW) Doppler
SonoHD2 Noise Reduction
SonoMB/MBe Image Compounding
Steered CW Doppler
Velocity Color Doppler
Tissue Doppler Imaging (TDI) | | | |
| PW Doppler | Available | Available | | | |
| CW Doppler | Available | Available | | | |
| Velocity Color Doppler | Available | Available | | | |
| Elastography (Strain), and Strain Rate Imaging | Not available | Available | | | |
| ECG Feature | 3-lead ECG input | 3-lead ECG input | | | |
| DICOM | DICOM 3.0 | DICOM 3.0 | | | |
| IMT Measurement | Not available | Available | | | |
| Measurement and Calculations | Obstetrical, cardiac, volume, M-mode, PW and CW Doppler measurement and calculation packages | Obstetrical, cardiac, volume, M-mode, PW and CW Doppler measurement and calculation packages | | | |
| #Transmit Channels | 128 digital channels | 128 digital channels | | | |
| #Receive Channels | 64 digital channels
(128 digital channels using Synthetic Aperture) | 64 digital channels
(128 digital channels using Synthetic Aperture) | | | |
| Patient Contact | Patient Contact
Materials | Transducers: | | Transducers: | Manufacturer |
| | Acrylonitrile-butadien-styrene (ABS)
Dow Medical Adhesive, Type A
Epoxy paste adhesive.
Polysulfone UDEL P1700 | Acrylonitrile-butadien-styrene (ABS)
Cycoloy
Dow Medical Adhesive, Type A
Epoxy paste adhesive.
Polysulfone UDEL P1700 | | | |
:
.
·
3
| Feature | SonoSite X-Porte Ultrasound
System
(this submission) | SonoSite Edge Ultrasound System
(K113156) |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Polyurethane
Poly-Vinyl-Chloride (PVC)
Silicone Rubber
Urethane | Polyurethane
Poly-Vinyl-Chloride (PVC)
Silicone Rubber
Urethane |
| | Needle Guides:
Acetal copolymer
Acrylonitrile-butadien-styrene (ABS) | Needle Guides:
Acetal copolymer
Acrylonitrile-butadien-styrene (ABS) |
| System
Characteristics | X-Porte (stand configuration):
Beamformer 128/128 using SA (configurable)
12.1" Capacitive touch screen interface
19" LED LCD HD external monitor
256 gray shades on LED LCD | Edge:
Beamformer 128/128 using SA (configurable)
Hand held display and control
Single 12.1" Liquid Crystal Display (LCD)
256 gray shades on LCD |
| | 6 USB 2.0 ports | 2 USB ports |
| | Dimensions: 15.6" (W) x 13.2" (L) x 3.1" (H) | Dimensions: 12.9"(W) x 12.4 (L) x 2.5"(H) |
| | Weight (fully configured with stand, all options
and 3 transducers connected): 148.1 lbs | Weight: 8.5 lbs |
| | Stand base Dimensions: 26.4" L x 21.2" W
Stand Height (max): 64" (monitor up)
Stand Height (min): 42.2" (monitor down) | |
| | System operates via battery or AC power
mounted on the stand. | System operates via battery or AC power |
| | Battery life: 1 hour operational - 3 days idle | Battery operated (1.5 - 4 hour operation per
charge) |
| | Input: 100 - 240 VAC, 50/60 Hz
Output 1: 24VDC output, 275 W max
Output 2: 100-240VAC, 50-60 Hz (AC Printer) | 100 - 240V options, 50/60 Hz, 15VDC output |
| | Wireless 802.11 (a/b/g/n) support for image
transfer | Wireless 802.11 (a\b\g) support for image
transfer |
| | X-Porte (desktop configuration): | |
| | Same software features/capabilities as the
stand configuration. Does not have the stand,
touch panel interface, DVR, and mobile power
unit. | |
| | AC power
100 - 240V options, 50/60 Hz | |
| 510(k) Track | Track 3 | Track 3 |
:
4
K133134
Page 5 of 5
7) Determination of Substantial Equivalence:
Summary of Non-Clinical Tests:
The X-Porte Ultrasound System has been evaluated for electrical, thermal, mechanical and EMC safety. Additionally, cleaning/disinfection, biocompatibility, and acoustic output have been evaluated, and the device has been found to conform to applicable mandatory medical device safety standards. Assurance of quality was established by employing the following elements of product development: Design Phase Reviews, Risk Assessment, Requirements Development, System and Software Verification, Hardware Verification, Safety Compliance Verification, Clinical Validation. All patient contact materials are biocompatible and are materials that are already used in the predicate device. Reports for these elements of product development are referenced in Attachment 6.
The X-Porte Ultrasound System is designed to comply with the following voluntary standards.
| Reference No. | Title | |
|---|---|---|
| AAMI/ANSI/ISO | ||
| 10993-1 | Biological evaluation of medical devices -- Part 1: Evaluation and testing within a | |
| risk management process | ||
| IEC 60601-1 | Medical electrical equipment - Part 1: General requirements for basic safety and | |
| essential performance | ||
| IEC 60601-1-2 | Medical electrical equipment - Part 1-2: General requirements for basic safety | |
| and essential performance - Collateral standard: Electromagnetic compatibility - | ||
| Requirements and tests | ||
| IEC 60601-2-37 | Particular Requirements for the basic safety and essential performance of | |
| ultrasonic medical diagnostic and monitoring equipment | ||
| ISO 14971 | Medical devices - Application of risk management to medical devices | |
| NEMA UD 2-2004 | Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment | |
| NEMA UD 3-2004 | Standard for Real-Time Display of Thermal and Mechanical Acoustic Output | |
| Indices on Diagnostic Ultrasound Equipment, American Institute of Ultrasound in | ||
| Medicine | ||
| NEMA PS 3.15 | NEMA Ps 3.15:2011, Digital Imaging and Communications in Medicine | |
| (DICOM), Part 15: Security and System Management Profiles |
Summary of Clinical Tests:
The SonoSite X-Porte Ultrasound System and transducers, subject of this submission, did not reguire clinical studies to support the determination of substantial equivalence.
8) Conclusion:
Intended uses and other key features are consistent with traditional clinical practice and FDA quidance. The X-Porte device and predicate both conform to applicable electromedical device safety standards with compliance verified through independent evaluation. The X-Porte device and predicate both meet FDA requirements for Track 3 devices, share indications for use, have biosafety equivalence and are manufactured using the same ISO 13485 quality system. FUJIFILM SonoSite, Inc. believes that the X-Porte Ultrasound System is substantially equivalent with regard to safety and effectiveness to the predicate device(s).
5
Image /page/5/Picture/0 description: The image shows a logo with a stylized bird-like symbol consisting of three curved lines, suggesting movement or flight. The symbol is encircled by text, which appears to be part of the organization's name or a related phrase. The logo has a simple, clean design, often used by government agencies or organizations to convey a sense of authority and professionalism.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-Gold Silver Spring, MI) 20993-0002
November 4, 2013
FUJIFILM SONOSITE, INC. C/O MARK JOB RESPONSIBLE THIRD PARTY OFFICIAL REGULATORY TECHNOLOGY SERVICES LLC 1394 25TH STREET NW BUFFALOMN 55313
Re: K133134
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: October 22, 2013 Received: October 23, 2013
Dear Mr. Job:
We have reviewed vour 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 fiability 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 SonoSite X-Porte™ Ultrasound System, as described in your premarket notification:
Transducer Model Number
C60xp/5-2 MHz Transducer ICTxp/9-5 MHz Transducer 1.38xp/10-5 MHz Transducer FFFL50xp/15-6 MHz Transducer 1.25xp/13-6 MHz Transducer P21xp/5-1 MHz Transducer
If your device is classified (see above) into cither 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.
6
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 vour 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 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 radiution 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrvidefault.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometries/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance 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.
Sincerely sours.
lor
Janine Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
7
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
51D(k) Number (if known) K133134
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 iclan 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) Trans-vaginal Musculo-skei. (Convent.) Musculo-skel. (Superfic.) Cardiac Adult Cardiac Pediatric Peripheral vessel
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
O 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)
Smh.7)
FORM FDA 3881 (9/13)
CRC Publishing Services (201) 344-7440 E
8
| 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 | Mode of Operation | ||||||
| B | M | PWD | CWD | Color | |||
| Doppler | Combined | ||||||
| (Spec.) | Other | ||||||
| (Spec.) | |||||||
| Ophthalmic | N | N | N | N | B+M; B+CD | 1-5 | |
| Fetal | N | N | N | N | B+M; B+PWD; B+CD | 1-3,5 | |
| Abdominal | N | N | N | N | B+M; B+PWD; | ||
| B+CWD; 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.) | N | N | N | N | |||
| Laparoscopic | N | N | N | N | |||
| Pediatric | N | N | N | N | B+M; B+PWD; | ||
| B+CWD; B+CD | 1-5 | ||||||
| Small Organ (breast, thyroid, | |||||||
| testicles, prostate) | N | N | N | N | B+M; B+PWD | ||
| B+CD | 1-5 | ||||||
| Neonatal Cephalic | |||||||
| Adult Cephalic | |||||||
| Trans-rectal | |||||||
| Trans-vaginal | N | N | N | N | B+M; B+PWD; B+CD | 1,5 | |
| Trans-urethral | |||||||
| Trans-esoph. (non-Card.) | |||||||
| Musculo-skel. (Convent.) | N | N | N | N | B+M; B+PWD | ||
| B+CD | 1-5 | ||||||
| Musculo-skel. (Superfic.) | N | N | N | N | B+M; B+PWD; B+CD | 1,4,5 | |
| Intra-luminal | |||||||
| Other (spec.) | |||||||
| Cardiac Adult | N | N | N | N | N | B+M; B+PWD; | |
| B+CWD; B+CD | 1-3,5 | ||||||
| Cardiac Pediatric | N | N | N | N | N | B+M; B+PWD; | |
| B+CWD; B+CD | 1-3,5 | ||||||
| Trans-esophageal (card.) | |||||||
| Other (spec.) | |||||||
| Peripheral vessel | N | N | N | N | B+M; B+PWD; B+CD | 1-5 | |
| Other (spec.) |
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.
2: Tissue Harmonic Imaging (THI)
3: Tissue Doppler Imaging (TDI)
3: Tissue Doppler Imaging (TDI)
4: Steep Needle Profiling (Sono MBe)
5: Multi-beam Imaging (SonoMB) in B-Mode
9
| 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 | N | N | N | N | B+M; B+PWD; B+CD | 1,2,5 | |
| Abdominal | N | N | N | N | B+M; B+PWD; B+CD | 1,2,5 | |
| Intra-operative (Abdominal | |||||||
| organs and vascular) | N | N | N | N | B+M; B+PWD; B+CD | 1,2,5 | |
| 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 1.3.2: 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.
2: Tissue Harmonic Imaging (THI)
3: Tissue Doppler Imaging (TDI)
4: Steep Needle Profiling (Sono MBe)
5: Multi-beam Imaging (SonoMB) in B-Mode
10
Table 1.3.3: 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 | N | N | N | N | B+M; B+PWD; B+CD | 1,4,5 | |
| Intra-operative (Abdominal | |||||||
| organs and vascular) | N | N | N | N | B+M; B+PWD; B+CD | 1,4,5 | |
| Intra-operative (Neuro.) | |||||||
| Laparoscopic | |||||||
| Pediatric | N | N | N | N | B+M; B+PWD; B+CD | 1,4,5 | |
| Small Organ (breast, thyroid, | |||||||
| testicles, prostate) | N | N | N | N | 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.) | N | N | N | N | B+M; B+PWD; B+CD | 1,4,5 | |
| Musculo-skel. (Superfic.) | N | N | N | N | B+M; B+PWD; B+CD | 1,4,5 | |
| 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 | 1,4,5 | |
| 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 In Heades Pinegally (Color Parisheral new block procedures. Color Doppler includes Power/Velocity/Variance.
Imaging guidance (C maging ( ( HI)
2: Tissue Harmonic Imaging (THI)
3: Tissue Doppler Imaging (TDI)
4: Steep Needle Profiling (Sono MBe)
5: Multi-beam Imaging (SonoMB) in B-Mode
11
| 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 | Mode of Operation | ||||||
| B | M | PWD | CWD | Color | |||
| Doppler | Combined | ||||||
| (Spec.) | Other | ||||||
| (Spec.) | |||||||
| Ophthalmic | |||||||
| Fetal | N | N | N | N | 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 | N | N | N | N | 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 1.3.4: Diagnostic Ultrasound Indications for Use Form - ICTxp/9-5Transducer
No 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 analomical structures and imaging guidance for peripheral nerve block procedures. Color Doppler includes Power/Velocity/Variance.
2: Tissue Harmonic Imaging (THI)
3: Tissue Doppier Imaging (TDI)
4: Steep Needle Profiling (Sono MBe)
6: Multi-beam Imaging (SonoMB) in B-Mode
12
| 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 | Mode of Operation | |||||||
| B | M | PWD | CWD | Color | ||||
| Doppler | Combined | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | N | N | N | N | B+M; B+PWD; B+CD | 1,4,5 | ||
| Fetal | ||||||||
| Abdominal | N | N | N | N | B+M; B+PWD; B+CD | 1,4,5 | ||
| Intra-operative (Abdominal | ||||||||
| organs and vascular) | N | N | N | N | B+M; B+PWD; B+CD | 1,4,5 | ||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | B+M; B+PWD; B+CD | 1,4,5 | ||
| Small Organ (breast, thyroid, | ||||||||
| testicles, prostate) | N | N | N | N | 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.) | N | N | N | N | B+M; B+PWD; B+CD | 1,4,5 | ||
| Musculo-skel. (Superfic.) | N | N | N | N | B+M; B+PWD; B+CD | 1,4,5 | ||
| 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 | 1,4,5 | ||
| Other (spec.) |
Table 1.3.5: 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 This Not Southers of Dock procedures. Color Doppler includes Power/Velocity/Variance.
imaging guidance for periores (THI)
2: Tissue Harmonic Imaging (THI)
3: Tissue Doppler Imaging (TDI)
4: Steep Needle Profiling (Sono MBe)
5: Multi-beam Imaging (SonoMB) in B-Mode
13
| 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 | N | N | N | N | B+M; B+PWD; B+CD | 1,4,5 | |
| Intra-operative (Abdominal organs | |||||||
| and vascular) | N | N | N | N | B+M; B+PWD; B+CD | 1,4,5 | |
| Intra-operative (Neuro.) | |||||||
| Laparoscopic | |||||||
| Pediatric | N | N | N | N | B+M; B+PWD; B+CD | 1,4,5 | |
| Small Organ (breast, thyroid, | |||||||
| testicles, prostate) | N | N | N | N | 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.) | N | N | N | N | B+M; B+PWD; B+CD | 1,4,5 | |
| Musculo-skel. (Superfic.) | N | N | N | N | B+M; B+PWD; B+CD | 1,4,5 | |
| 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 | 1,4,5 | |
| Other (spec.) |
Table 1.3.6: 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 if indudes integring to assist in the placement of necess Color Doppler includes Power/Velocity/Variance.
2: Tissue Harmonic Imaging (THI)
3: Tissue Doppler Imaging (TDI)
4: Steep Needle Profiling (Sono MBe)
5: Multi-beam Imaging (SonoMB) in B-Mode
14
| System: | FUJIFILM SonoSite X-Porte Ultrasound System | ||||||
|---|---|---|---|---|---|---|---|
| Transducer: | P21xp/5-1 MHz Transducer | ||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human | ||||||
| body as follows: | |||||||
| Clinical Application | Mode of Operation | ||||||
| Combined | |||||||
| Color | Other | ||||||
| B | M | PWD | CWD | Doppler | (Spec.) | (Spec.) | |
| Ophthalmic | |||||||
| Fetal | N | N | N | N | B+M; B+PWD; B+CD | 1-3.5 | |
| Abdominal | N | N | N | N | N | B+M; B+PWD; B+CWD; B+CD | 1-3.5 |
| Intra-operative (Abdominal | |||||||
| organs and vascular) | N | N | N | N | B+M; B+PWD; B+CD | 1-3.5 | |
| Intra-operative (Neuro.) | |||||||
| Laparoscopic | |||||||
| Pediatric | N | N | N | N | B+M; B+PWD | 1-3.5 | |
| Small Organ (breast, thyroid, | |||||||
| testicles, prostate) | N | N | N | N | B+M; B+PWD; B+CD | 1-3.5 | |
| 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 | 1-3.5 | |
| Musculo-skel. (Superfic.) | |||||||
| Intra-luminal | |||||||
| Other (spec.) | |||||||
| Cardiac Adult | N | N | N | N | N | B+M; B+PWD; B+CWD; B+CD | 1-3.5 |
| Cardiac Pediatric | N | N | N | N | N | B+M; B+PWD; B+CWD; B+CD | 1-3.5 |
| Trans-esophageal (card.) | |||||||
| Other (spec.) | |||||||
| Peripheral vessel | N | N | N | N | B+M; B+PWD; B+CD | 1-3.5 | |
| Other (spec.) |
Table 1.3.7: Diagnostic Ultrasound Indications for Use Form - P21xp/5-1 Transducer
N= new Indication; P= previously cleared by FDA; E= added under this appendix
Additional Comments:
1: Includes imaging to assist in the placement of needles and catheters in vascular or other analomical structures and It indused integring to economic and other procedures Color Doppler includes Power/Velocity/Variance.
2: Tissue Harmonic Imaging (THI)
3: Tissue Doppler Imaging (TDI)
4: Steep Needle Profiling (Sono MBe)
5: Multi-beam Imaging (SonoMB) in B-Mode