SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound System

K162045 · FUJIFILM Sonosite, Inc. · IYN · Aug 18, 2016 · Radiology

Device Facts

• Record ID: K162045
• Device Name: SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound System
• Applicant: FUJIFILM Sonosite, Inc.
• Product Code: IYN · Radiology
• Decision Date: Aug 18, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The 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. The SonoSite SII Ultrasound System is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis of the human body.

Device Story

SonoSite Edge II (laptop-style) and SII (mountable-style) are general-purpose, software-controlled diagnostic ultrasound systems. Devices acquire/display high-resolution, real-time ultrasound data via multiple imaging modes (B-mode, M-mode, Color Doppler, etc.). Operated by qualified physicians/healthcare professionals in clinical settings. Systems use digital beamforming (128/128 channels) to process transducer inputs; outputs displayed on 12.1" LCD. Features include SonoHD2 noise reduction, SonoMB/MBe image compounding, and measurement/calculation packages for various clinical applications. Systems support battery or AC power, DICOM connectivity, and wireless image transfer. Output affects clinical decision-making by providing diagnostic imaging for evaluation of human body structures and fluid flow. Benefits include portable, high-resolution imaging for point-of-care diagnostics and procedural guidance.

Clinical Evidence

No clinical studies were required to support the determination of substantial equivalence. Evidence is based on bench testing, including electrical safety, EMC, biocompatibility, and acoustic output characterization.

Technological Characteristics

Portable/mountable digital ultrasound systems. Transducers: Linear, Curved Linear, Intracavitary, Phased Array. Materials: ABS, Cycoloy, Polycarbonate, Polysulfone UDEL P1700, PVC, Silicone, Urethane. Connectivity: USB, Wireless 802.11. Beamformer: 128/128 channels. Display: 12.1" LCD. Standards: AAMI/ANSI ES60601-1, IEC 60601-2-37, IEC 62359, NEMA UD2-2004.

Indications for Use

Indicated for Ophthalmic, Fetal-OB/GYN, Abdominal, Pediatric, Small Organ (breast, thyroid, testicle, prostate), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional/Superficial), Cardiac (Adult/Pediatric), Trans-esophageal (cardiac), and Peripheral Vessel imaging. Includes needle guidance for vascular/anatomical structures and peripheral nerve blocks.

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 II Ultrasound System (K153626)
• SonoSite SII Ultrasound System (K160734)
• SonoSite Edge Ultrasound System (K133454)
• FUJIFILM FC1 Ultrasound System (K160406)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 18, 2016

FUJIFILM SonoSite, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street, NW BUFFALO MN 55313

Re: K162045

Trade/Device Name: SonoSite SII Ultrasound System and 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: July 21, 2016 Received: July 25, 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

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forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Sincerely yours,

Michael D.'Hara

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health For

Enclosure

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# Indications for Use

510(k) Number (if known) K162045

Device Name SonoSite Edge II Ultrasound System

#### Indications for Use (Describe)

The 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 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-rectal 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) | |
|--------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# SonoSite Edge II Ultrasound System:

The following are the Indications for Use for the SonoSite Edge II Ultrasound System

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 | P | P | P | | P | B+M; B+PWD; B+CD | 1-5 |
| 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<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) | P | P | P | | P | B+M; B+PWD; B+CD | 1-5 |
| Neonatal Cephalic | P | P | P | | P | B+M; B+PWD; B+CD | 1-3,5 |
| Adult Cephalic | P | P | P | | P | B+M; B+PWD; B+CD | 1-3,5 |
| Trans-rectal | N | N | N | | N | B+M; B+PWD; B+CD | 1,5 |
| 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 | 1,2,4,5 |
| 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 | P | B+M; B+PWD; B+CWD; B+CD | 1-5 |
| Cardiac Pediatric | P | P | P | P | P | B+M; B+PWD; B+CWD; B+CD | 1-5 |
| Trans-esophageal (card.) | P | P | P | P | P | B+M; B+PWD; B+CWD; B+CD | 1,3 |
| 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 assistin 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) K153626 (Edge II).

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| System: | FUJIFILM SonoSite Edge II Ultrasound System | | | | | | |
|-------------------------------------------------------|---------------------------------------------------------------------------------------|---|-----|-----|------------------|---------------------|------------------|
| Transducer: | C8x/8-5 MHz Transducer | | | | | | |
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human<br>body as follows: | | | | | | |
| Clinical Application | Mode of Operation | | | | | | |
| | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | | | | | | | |
| Fetal | | | | | | | |
| Abdominal | | | | | | | |
| Intra-operative (Abdominal<br>organs and vascular) | | | | | | | |
| Intra-operative (Neuro.) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | | | | | | | |
| Small Organ (breast, thyroid,<br>testicles, prostate) | | | | | | | |
| Neonatal Cephalic | | | | | | | |
| Adult Cephalic | | | | | | | |
| Trans-rectal | P | P | P | | P | B+M; B+PWD; B+CD | 1,5 |
| Trans-vaginal | | | | | | | |
| 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 1.3-2: Diagnostic Ultrasound Indications for Use Form – C8x8-5 MHz 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 (Edge).

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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<br>body as follows: | | | | | | |
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | | | | | | | |
| Fetal | | | | | | | |
| Abdominal | P | P | P | | P | B+M; B+PWD; B+CD | 1,5 |
| 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 1.3-3: 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) K153626 (Edge II).

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Table 1.3-4: Diagnostic Ultrasound Indications for Use Form – C35x/8-3 MHz Transducer

| System: | FUJIFILM SonoSite Edge II Ultrasound System | | | | | | | |
|-------------------------------------------------------|---------------------------------------------------------------------------------------|---|-----|-----|------------------|---------------------|------------------|--|
| Transducer: | C35x/8-3 MHz Transducer | | | | | | | |
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human<br>body as follows: | | | | | | | |
| Clinical Application | Mode of Operation | | | | | | | |
| | 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 | 1,4,5 | |
| 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) | | | | | | | | |
| 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 assistin 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) K160406 (FC1).

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| 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<br>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 | 1,2,4,5 | |
| Abdominal | P | P | P | | P | B+M; B+PWD; B+CD | 1,2,4,5 | |
| Intra-operative (Abdominal<br>organs and vascular) | | | | | | | | |
| Intra-operative (Neuro.) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Pediatric | P | P | P | | P | B+M; B+PWD; B+CD | 1,2,4,5 | |
| Small Organ (breast, thyroid,<br>testicles, prostate) | | | | | | | | |
| Neonatal Cephalic | | | | | | | | |
| Adult Cephalic | | | | | | | | |
| Trans-rectal | | | | | | | | |
| Trans-vaginal | | | | | | | | |
| Trans-urethral | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | |
| Musculo-skel. (Convent.) | P | P | P | | P | B+M; B+PWD; B+CD | 1,2,4,5 | |
| Musculo-skel. (Superfic.) | | | | | | | | |
| Intra-luminal | | | | | | | | |
| Other (spec.) | | | | | | | | |
| Cardiac Adult | | | | | | | | |
| Cardiac Pediatric | | | | | | | | |
| Trans-esophageal (card.) | | | | | | | | |
| Other (spec.) | | | | | | | | |
| Peripheral vessel | P | P | P | | P | B+M; B+PWD; B+CD | 1,2,4,5 | |
| Other (spec.) | | | | | | | | |

Table 1.3-5: 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

All items marked "P" were previously cleared in 510(k) K153626 (Edge II).

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Table 1.3-6: Diagnostic Ultrasound Indications for Use Form – HFL38xi/13-6 Transducer

| 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<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 assistin 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) K153626 (Edge II).

{9}------------------------------------------------

| 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 Doppler | Combined (Spec.) | Other (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.) | | | | | | | | |

Table 1.3-7: Diagnostic Ultrasound Indications for Use Form – HFL50x/15-6 Transducer

N= new indication; P= previously cleared by FDA; E= added under this appendix

#### Additional Comments:

1: Includes imaging to assistin the placement of needler 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 MB

4: Steep Needle Profiling (Sono MBe)
5: Multi-beam Imaging (SonoMB) in B-Mode

All items marked "P" were previously cleared in 510(k) K153626 (Edge II).

{10}------------------------------------------------

| 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.) | | | | | | | |

Table 1.3-8: Diagnostic Ultrasound Indications for Use Form – HSL25x/13-6 Transducer

N= new indication; P= previously cleared by FDA; E= added under this appendix

#### Additional Comments:

1: Includes imaging to assistin the placement of needler 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) K153626 (Edge II).

{11}------------------------------------------------

| 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 |

Table 1.3-9: Diagnostic Ultrasound Indications for Use Form - ICTx/8-5 Transducer

N= new indication; P= previously cleared by FDA; E= added under this appendix

P

P

P

P

B+M; B+PWD; B+CD

1,5

#### Additional Comments:

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

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.)

1: Includes imaging to assist in the placement of needler 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) K153626 (Edge II).

{12}------------------------------------------------

| 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<br>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 1.3-10: 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) K153626 (Edge II).

{13}------------------------------------------------

Table 1.3-11: 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,<br>testicles. prostate) | P | P | P | | P | B+M; B+PWD; B+CD | 1,4,5 | |
| Neonatal Cephalic | | | | | | | | |
| Adult Cephalic | |…