SonoSite Edge II Ultrasound System
Device Facts
| Record ID | K153626 |
|---|---|
| Device Name | SonoSite Edge II Ultrasound System |
| Applicant | FUJIFILM Sonosite, Inc. |
| Product Code | IYN · Radiology |
| Decision Date | Jan 20, 2016 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric, 3rd-Party Reviewed |
Intended Use
The FUJIFILM SonoSite Edge II 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 Pediatric Small Organ (breast, thyroid, testicle, prostate) Neonatal Cephalic Adult Cephalic Trans-vaginal Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Cardiac Adult Cardiac Pediatric Trans-esophageal (cardiac) Peripheral Vessel
Device Story
Portable, laptop-style diagnostic ultrasound system; acquires/displays high-resolution, real-time ultrasound data. Operates on battery or AC power. Used by physicians/healthcare professionals in clinical settings. Inputs: ultrasound signals via various transducers (linear, curved, phased, intracavitary, TEE). Transforms inputs using digital beamforming (128/128) and software-controlled processing (B-mode, M-mode, Doppler, Tissue Harmonic Imaging, SonoHD2 noise reduction, SonoMB/MBe compounding). Outputs: real-time images and fluid flow analysis on 12.1" LCD. Assists in needle/catheter placement and peripheral nerve blocks. Benefits: provides diagnostic visualization and guidance for clinical decision-making.
Clinical Evidence
No clinical data. Bench testing only. Device evaluated for electrical, thermal, mechanical, and EMC safety, biocompatibility, and acoustic output per recognized standards (ISO 10993-1, IEC 60601-1, IEC 60601-2-37, IEC 62359, NEMA UD 2-2004).
Technological Characteristics
Portable ultrasound system; 12.1" LCD; 128/128 beamformer. Materials: ABS, Cycoloy, PEEK, Polycarbonate, Polysulfone, PVC, Silicone, Urethane. Modes: B-mode, M-mode, Color Doppler, PWD, CWD, TDI, SonoHD2, SonoMB/MBe. Connectivity: 802.11 (b/g/n) wireless, USB. Power: Battery/AC. Software: Life cycle processes per IEC 62304.
Indications for Use
Indicated for qualified physicians and healthcare professionals for diagnostic ultrasound imaging or fluid flow analysis of the human body, including ophthalmic, fetal, OB/GYN, abdominal, pediatric, small organ (breast, thyroid, testicle, prostate), neonatal/adult cephalic, trans-vaginal, musculo-skeletal, cardiac (adult/pediatric/trans-esophageal), 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 Edge Ultrasound System (K133454)
- SonoSite X-Porte Ultrasound System (K152209)
Related Devices
- K133454 — SONOSITE EDGE ULTRASOUND SYSTEM · FUJIFILM Sonosite, Inc. · Dec 16, 2013
- K113156 — SONOSITE EDGE ULTRASOUND SYSTEM · Sonosite,Inc. · Nov 15, 2011
- K133134 — X-PORTE ULTRASOUND SYSTEM · FUJIFILM Sonosite, Inc. · Nov 4, 2013
- K222648 — 5000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500 P, Ultrasound System 5500 W, Ultrasound System 5500 CV, Ultrasound System 5300 G, Ultrasound System 5300 P, Ultrasound System 5300 W) · Philips Ultrasound, LLC · Sep 27, 2022
- K231930 — Digital Ultrasonic Diagnostic Imaging System (Model: F6) · Guangdong Youkey Medical Co., Ltd. · Mar 22, 2024
Submission Summary (Full Text)
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing right, stacked on top of each other, with a flowing design below them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 20, 2016
FUJIFILM SonoSite, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street. NW BUFFALO MN 55313
Re: K153626
Trade/Device Name: SonoSite Edge II Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: January 13, 2016 Received: January 14, 2016
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.
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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,
Robert Ocks
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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# Indications for Use
#### 510(k) Number (if known) TBD K153626
Device Name
FUJIFILM SonoSite Edge II Ultrasound System
# Indications for Use (Describe)
The FUJIFILM SonoSite Edge II 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 Pediatric Small Organ (breast, thyroid, testicle, prostate) Neonatal Cephalic Adult Cephalic Trans-vaginal Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Cardiac Adult Cardiac Pediatric Trans-esophageal (cardiac) Peripheral Vessel
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Table 1.3-1: Diagnostic Ultrasound Indications for Use Form – FUJIFILM SonoSite Edge II Ultrasound System
| System: | FUJIFILM SonoSite Edge II Ultrasound System | | | | | | |
|-------------------------------------------------------|---------------------------------------------------------------------------------------|-------------------|-----|-----|------------------|-------------------------|------------------|
| Transducer: | N/A | | | | | | |
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body<br>as follows: | | | | | | |
| Clinical Application | | Mode of Operation | | | | | |
| | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | N | N | N | | N | B+M; B+PWD; B+CD | 1-5 |
| Fetal | N | N | N | | N | B+M; B+PWD; B+CD | 1-5 |
| Abdominal | N | N | N | | N | B+M; B+PWD; B+CD | 1-5 |
| Intra-operative (Abdominal<br>organs and vascular) | | | | | | | |
| Intra-operative (Neuro.) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | N | N | N | | N | B+M; B+PWD; B+CD | 1-5 |
| Small Organ (breast, thyroid,<br>testicles, prostate) | N | N | N | | N | B+M; B+PWD; B+CD | 1-5 |
| Neonatal Cephalic | N | N | N | | N | B+M; B+PWD; B+CD | 1-3,5 |
| Adult Cephalic | N | N | N | | N | B+M; B+PWD; B+CD | 1-3,5 |
| 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 | 1,2,4,5 |
| 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 | 1-5 |
| Cardiac Pediatric | N | N | N | N | N | B+M; B+PWD; B+CWD; B+CD | 1-5 |
| Trans-esophageal (card.) | N | N | N | N | N | B+M; B+PWD; B+CWD; B+CD | 1,3 |
| 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. M-Mode includes color 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
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| System: | | FUJIFILM SonoSite Edge II Ultrasound System | | | | | |
|-------------------------------------------------------|-------------------|-------------------------------------------------------------------|-----|-----|------------------|---------------------|------------------|
| Transducer: | | C11x/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) | | | | | | | |
| Intra-operative (Neuro.) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | P | P | P | | P | B+M; B+PWD; B+CD | 1,5 |
| Small Organ (breast, thyroid,<br>testicles. prostate) | | | | | | | |
| 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 – C11x/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 color 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) K133454.
{5}------------------------------------------------
| System: | FUJIFILM SonoSite Edge II Ultrasound System | | | | | | |
|----------------------------------------------------|------------------------------------------------------------------------------------|---|-----|-----|---------------|------------------|---------------|
| Transducer: | rC60xi/5-2 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 | N | N | N | | N | B+M; B+PWD; B+CD | 1,2,4,5 |
| Abdominal | N | N | N | | N | B+M; B+PWD; B+CD | 1,2,4,5 |
| Intra-operative (Abdominal organs and vascular) | | | | | | | |
| Intra-operative (Neuro.) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | N | N | N | | N | 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.) | N | N | N | | N | 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 | N | N | N | | N | B+M; B+PWD; B+CD | 1,2,4,5 |
| Other (spec.) | | | | | | | |
Table 1.3-3 Diagnostic Ultrasound Indications for Use Form – rC60xi/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 color M-Mode.
2: Tissue Harmonic Imaging (THI)
- 3: Tissue Doppler Imaging (TDI)
4: Steep Needle Profiling (Sono MBe)
5: Multi-beam Imaging (SonoMB) in B-Mode
{6}------------------------------------------------
| System: | FUJIFILM SonoSite Edge II Ultrasound System | | | | | | | |
|----------------------------------------------------|------------------------------------------------------------------------------------|-------------------|---|-----|-----|---------------|------------------|---------------|
| Transducer: | HFL38xi/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 | | | | | | | | |
| Fetal | | | | | | | | |
| Abdominal | | P | P | P | | P | B+M; B+PWD; B+CD | 1,4,5 |
| Intra-operative (Abdominal 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, 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 1.3-4 Diagnostic Ultrasound Indications for Use Form – HFL38xi/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 color 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) K152209.
{7}------------------------------------------------
| Table 1.3-5 Diagnostic Ultrasound Indications for Use Form – HFL50x/15-6 Transducer | | | | | | | |
|-------------------------------------------------------------------------------------|-------------------------------------------------------------------|---|-----|-----|------------------|---------------------|------------------|
| System: | FUJIFILM SonoSite Edge II Ultrasound System | | | | | | |
| Transducer: | HFL50x/15-6 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<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) | | | | | | | |
| 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 color 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) K133454.
{8}------------------------------------------------
| Table 1.3-6 Diagnostic Ultrasound Indications for Use Form – HSL25x/13-6 Transducer | |
|-------------------------------------------------------------------------------------|--|
|-------------------------------------------------------------------------------------|--|
| System: | FUJIFILM SonoSite Edge II Ultrasound System | | | | | | |
|-------------------------------------------------------|---------------------------------------------------------------------------------------|-------------------|-----|-----|------------------|---------------------|------------------|
| Transducer: | HSL25x/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) | | | | | | | |
| 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 color 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) K152209.
{9}------------------------------------------------
Table 1.3-7 Diagnostic Ultrasound Indications for Use Form – ICTx/8-5 Transducer
| System: | FUJIFILM SonoSite Edge II Ultrasound System | | | | | | |
|----------------------------------------------------|------------------------------------------------------------------------------------|---|-----|-----|-------------------|------------------|---------------|
| Transducer: | ICTx/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 | 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.) | | | | | | | |
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 color 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) K133454.
{10}------------------------------------------------
| System: | FUJIFILM SonoSite Edge II Ultrasound System | | | | | | |
|----------------------------------------------------|------------------------------------------------------------------------------------|---|-----|-----|---------------|------------------|---------------|
| Transducer: | L25x/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 | | | | | | | |
| Abdominal | P | P | P | | P | B+M; B+PWD; B+CD | 1,4,5 |
| Intra-operative (Abdominal 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, 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 1.3-8 Diagnostic Ultrasound Indications for Use Form – L25x/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 color 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) K152209.
{11}------------------------------------------------
Table 1.3-9 Diagnostic Ultrasound Indications for Use Form - L38xi/10-5 Transducer, L38xi/10-5 Armored Transducer
| System: | FUJIFILM SonoSite Edge II Ultrasound System | | | | | | | |
|-------------------------------|-------------------------------------------------------------------|----------------------------|-----|-----|---------|------------------|---------|--|
| Transducer: | L38xi/10-5 MHz Transducer, L38xi/10-5 MHz Armored 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 | | | | | | | | |
| 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, | | | | | | | | |
| 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.) | | | | | | | | |
| Musculo-skel. (Superfic.) | | | | | | | | |
| 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 color 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) K152209.
{12}------------------------------------------------
| System: | FUJIFILM SonoSite Edge II Ultrasound System | | | | | | |
|-------------------------------------------------------|------------------------------------------------------------------------|---|-----|-----|------------------|-------------------------|------------------|
| Transducer: | P10x/8-4 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 | P | P | P | | P | B+M; B+PWD; B+CD | 1,5 |
| Abdominal | P | P | P | | P | B+M; B+PWD; B+CD | 1,5 |
| Intra-operative (Abdominal | | | | | | | |
| organs and vascular) | | | | | | | |
| 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 | P | P | P | | P | B+M; B+PWD; B+CD | 1,5 |
| Trans-rectal | | | | | | | |
| Trans-vaginal | | | | | | | |
| Trans-urethral | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | |
| Musculo-skel. (Convent.) | P | P | P | | P | B+M; B+PWD; B+CD | 1,5 |
| Musculo-skel. (Superfic.) | | | | | | | |
| Intra-luminal | | | | | | | |
| Other (spec.) | | | | | | | |
| Cardiac Adult | P | P | P | P | P | B+M; B+PWD; B+CWD; B+CD | 1,3,5 |
| Cardiac Pediatric | P | P | P | P | P | B+M; B+PWD; B+CWD; B+CD | 1,3,5 |
| Trans-esophageal (card.) | | | | | | | |
| Other (spec.) | | | | | | | |
| Peripheral vessel | P | P | P | | P | B+M; B+PWD; B+CD | 1,5 |
| Other (spec.) | | | | | | | |
Table 1.3-10 Diagnostic Ultrasound Indications for Use Form – P10x/8-4 Transducer
N= new indication; P= previously cleared by FDA; E= added un…
