VOLUSON S6, VOLUSON S8

K141639 · GE Healthcare · IYN · Jul 18, 2014 · Radiology

Device Facts

• Record ID: K141639
• Device Name: VOLUSON S6, VOLUSON S8
• Applicant: GE Healthcare
• Product Code: IYN · Radiology
• Decision Date: Jul 18, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The device is a general-purpose ultrasound system. Specific clinical applications and exam types include: Fetal (Obstetrics); Abdominal (including renal and GYN/pelvic): Pediatric: Small Organ (breast, testes, thyroid, salivary gland. lymph nodes, pediatric and neonatal patients); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial: Transrectal (TR); Transvaginal (TV).

Device Story

Mobile console ultrasound system with keyboard, controls, LCD display, and electronic-array transducers. Performs real-time digital acquisition, processing, and display of ultrasound images. Used in clinical settings by healthcare professionals for general radiology, cardiology, and vascular imaging. Features include HDLive, SonoIT, SonoBiometry, and SonoL&D. Output displayed on console for clinician review to support diagnostic evaluation and clinical decision-making. Benefits include non-invasive visualization of internal anatomy and fluid flow.

Clinical Evidence

Bench testing only. No clinical studies required to support substantial equivalence. Device evaluated for acoustic output, biocompatibility, cleaning/disinfection, thermal, electrical, electromagnetic, and mechanical safety per AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, NEMA UD 2/UD 3, and ISO 10993-1.

Technological Characteristics

Mobile ultrasound console with electronic-array transducers. Materials are biocompatible. Imaging modes include B, M, PW/CW Doppler, Color/Power Doppler, Harmonic Imaging, and Coded Pulse. Connectivity includes DICOM. Software features include HDLive, SonoIT, SonoBiometry, and SonoL&D. Complies with AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, and NEMA UD 2/3.

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid flow analysis in fetal/obstetrics, abdominal (renal/GYN/pelvic), pediatric, small organ (breast, testes, thyroid, salivary gland, lymph nodes), neonatal/adult cephalic, cardiac, peripheral vascular, musculoskeletal, transrectal, and transvaginal 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

• Voluson S6, Voluson S8 Diagnostic Ultrasound System (K120741)
• Voluson E Series (K132913)
• Voluson P6/P8 (K122387)
• Vivid S5/S6 (K121063)

Submission Summary (Full Text)

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JUL 1 8 2014

K14/639.
Page 1 of 4

GE Healthcare 510(k) Premarket Notification Submission

### 510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided: Date: June 18, 2014 Submitter: GE Healthcare 9900 Innovation Dr Wauwatosa, WI 53226 Primary Contact Person: Bryan Behn Regulatory Affairs Manager GE Healthcare T:[phone] F:[phone] Chan Sook Kim Secondary Contact Person: Regulatory Affairs Leader GE Healthcare T: [phone] Voluson S6, Voluson S8 Ultrasound System Device: Trade Name: Voluson S6, Voluson S8 Common/Usual Name: Class II Classification Names: Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-1YN Product Code: Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-1YO Diagnostic Ultrasound Transducer, 21 CFR 892.1570. 90-ITX Predicate Device(s): K120741 Voluson S6, Voluson S8 Diagnostic Ultrasound System K132913 Voluson E Series K122387 Voluson P6/P8 K121063 Vivid S5/S6 The subject device consists of a mobile console with keyboard, Device Description: specialized controls, a color video LCD display with electronicarray transducers. It has the same general appearance, dimensions and weight as the unmodified device, it is a Track 3 generalpurpose imaging and analysis system providing real-time digital acquisition, processing and display capability intended for general radiology imaging and evaluation with some cardiology and vascular applications.

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# GE Healthcare

510(k) Premarket Notification Submission

Intended Use: The device is a general-purpose ultrasound system. Specific clinical applications and exam types include: Fetal (Obstetrics); Abdominal (including renal and GYN/pelvic): Pediatric: Small Organ (breast, testes, thyroid, salivary gland. lymph nodes, pediatric and neonatal patients); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial: Transrectal (TR); Transvaginal (TV).

The Voluson S6. Voluson S8 employs the same fundamental Technology: scientific technology as its predicate devices

Determination of Substantial Equivalence:

Comparison to Predicate Device(s):

The Voluson S6/S8 systems are substantially equivalent to the predicate devices with regard to intended use, imaging capabilities, technological characteristics and safety and effectiveness.

- . The systems are all intended for diagnostic ultrasound imaging and fluid flow analysis.
- . The Voluson S6/S8 and predicate Voluson S6/S8 systems have the same clinical intended use
- . The Voluson S6/S8 and predicate Voluson S6/S8systems have the same imaging modes.
- . The Voluson S6/S8 and predicate Voluson S6/S8 systems transducers are identical except for the 12S-RS (same as predicate Vivid S5/S6 K121063), RAB2-6-RS (same as predicate Voluson P6/P8 K122387) and RAB6-RS (Equivalent to RAB6-D on predicate Voluson E Series K132913).
- . The systems are manufactured with materials which have been evaluated and found to be safe for the intended use of the device.
- . The systems have acoustic power levels which are below the applicable FDA limits.
- . The Voluson S6/S8 and predicate Voluson S6/S8 systems have similar capability in terms of performing measurements, capturing digital images, reviewing and reporting studies.
- New software features added to Voluson S6/S8: HDLive. t t Sono IT. SonoBiometry and Sono L&D are the same features cleared on predicate Voluson E Series(K132913).
- ♥ The Voluson S6/S8 and predicate systems have been

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Image /page/2/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a circle. The letters are white against a black background, and the circle is also black.

### GE Healthcare

510(k) Premarket Notification Submission

designed in compliance with approved electrical and physical safety standards.

### Summary of Non-Clinical Tests:

. '

The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic, and mechanical safety. and has been found to conform to applicable medical device safety standards. Voluson S6, Voluson S8 and its applications comply with voluntary standards;

- 1. AAMI/ANSI ES60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety
- 2. IEC60601-1-2. Medical Electrical Equipment -Part 1-2:General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility Requirements and Tests
- 3. IEC60601-2-37, Medical Electrical Equipment -Part 2-37:Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment
- 4. NEMA UD 3. Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- 5. ISO10993-1, Biological Evaluation of Medical Devices- Part 1: Evaluation and Testing- Third Edition
- 6. NEMA UD 2, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
- 7. ISO14971, Application of risk management to medical devices
- NEMA, Digital Imaging and Communications in 8. Medicine (DICOM) Set. (Radiology)

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Image /page/3/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circular frame. The letters are stylized and connected, creating a distinctive monogram. The logo is in black and white.

## GE Healthcare

510(k) Premarket Notification Submission

The following quality assurance measures are applied to the development of the system:

- Risk Analysis ●
- Requirements Reviews .
- Design Reviews .
- Testing on unit level (Module verification) .
- Integration testing (System verification) .
- . Final Acceptance Testing (Validation)
- Performance testing (Verification) .
- Safety testing (Verification)

Transducer materials and other patient contact materials are biocompatible.

### Summary of Clinical Tests:

The subject of this premarket submission, Voluson S6, Voluson S8, did not require clinical studies to support substantial equivalence.

GE Healthcare considers the Voluson S6, Voluson S8 to be as Conclusion: safe, as effective, and performance is substantially equivalent to the predicate device(s).

Conclusion

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the border. Inside the circle is a stylized symbol that resembles three curved lines stacked on top of each other. The lines are thicker at the top and taper towards the bottom, creating a sense of movement or flow. The seal is black and white.

Public Health Service

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

July 18, 2014

GE Healthcare % Mr. Bryan Behn Regulatory Affairs Manager 9900 Innovation Drive WAUWATOSA WI 53226

Re: K141639

Trade/Device Name: Voluson S6, Voluson S8 Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO. ITX Dated: June 18, 2014 Received: June 19, 2014

Dear Mr. Behn:

We have reviewed your Scetion 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially cquivalent (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: CDRFI does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

This determination of substantial equivalence applies to the following transducers intended for use with the Voluson S6, Voluson S8 Diagnostic Ultrasound System, as described in your premarket notification:

| | Transducer Model Number | |
|------------|-------------------------|-----------|
| RAB4-8-RS | 4C-RS | E8C-RS |
| C1-5-RS | 121.-RS | AB2-7-RS |
| RIC5-9W-RS | RAB2-5-RS | 8C-RS |
| M1.6-15-RS | 3Sc-RS | 91.-RS |
| P2D | 12S-RS | RAB2-6-RS |
| RAB6-RS | | |

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

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Page 2-Mr. Behn

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.

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/ResourcesforYou/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 vours.

for

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known)

K141639

Device Name

Voluson S6/Voluson S8 Diagnostic Ultrasound System

Indications for Use (Describe)

The device is a general-purpose ultrasound system. Specific clinical applications and exam types include: Fetal (Obsterics); Abdominal (including renal and GYN/pelvic); Pediatric; Small Organ (breast, testes, thyroid, salivary gland, Ivmph nodes, pediatric and neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric'; Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transrectal (TV).

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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)

Sm.h.7)

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### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

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### Diagnostic Ultrasound Indications for Use Form GE Voluson S6/S8 Ultrasound System

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[Notes] | |
|----------------------------------------------------|---|---|---------------|---------------|------------------|--------------------|------------------|--------------------|---------------------|----------------|------------------|--|
| Ophthalmic | P | P | P | P | P | P | P | P | P | P | | |
| Fetal / Obstetrics[1] | P | P | P | P | P | P | P | P | P | P | [5,6,9] | |
| Abdominal[1] | P | P | P | P | P | P | P | P | P | P | [5,6,9] | |
| Pediatric | P | P | P | P | P | P | P | P | P | P | [5,6,9] | |
| Small Organ[2] | P | P | P | P | P | P | P | P | P | P | [5,6,9] | |
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | P | [5] | |
| Adult Cephalic | P | P | P | P | P | P | P | P | P | P | | |
| Cardiac[1] | P | P | P | P | P | P | P | P | P | P | [5] | |
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | P | [5,6,9] | |
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | P | P | P | [5,6,9] | |
| Musculo-skeletal Superficial | P | P | P | P | P | P | P | P | P | P | [5,6,9] | |
| Other | | | | | | | | | | | | |
| Exam Type. Means of Access | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal[1] | P | P | P | P | P | P | P | P | P | P | [5,6,9] | |
| Transvaginal | P | P | P | P | P | P | P | P | P | P | [5,6,9] | |
| Transuretheral | | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |

N = new indication. P = previously cleared by FDA

| | | Abdominal includes renal. GYN/Pelvic Notes:

12) Small organ includes breast, testes. thereid, salivary gland, lymph nodes, pediation and neonatal patiens

| 3| Cardiac is Adult and Pediatric.

15| 3D/4D Imaging Mode.

16| Includes imaging of guidance of biopsy (2D/3D/4D).

|7] Includes infertility monitoring of follicle development.

[8] Includes urology/prostate.

19| Elastography imaging- Elasticity

| ° | Combined modes are B/M. B/Color M. B/PWD, B/Color/PWD, B/PWD

(PLEASE DO NOT WRITE BELUW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiotogical Health (OIR)

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#### Diagnostic Ultrasound Indications for Use Form

#### GE Voluson S6/S8 with RAB4-8-RS Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| | Mode of Operation | | | | | | | | | | |
|------------------------------------------------------------|-------------------|---|------------|------------|---------------|-----------------|---------------|----------------|------------------|-------------|---------------|
| Clinical Application<br><i>Anatomy: Region of Interest</i> | B | M | PW Doppler | CW Doppler | Color Doppler | Color M Doppler | Power Doppler | Combined Modes | Harmonic Imaging | Coded Pulse | Other [Notes] |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics[1] | P | P | P | | P | P | P | P | P | P | [5,6] |
| Abdominal[1] | P | P | P | | P | P | P | P | P | P | [5,6] |
| Pediatric | P | P | P | | P | P | P | P | P | P | [5,6] |
| Small Organ[2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac[1] | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | P | P | P | | P | P | P | P | P | P | [5,6] |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal[4] | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA

[I] Abdominal includes renal, G Y N/Pclvic Nolcs:

[2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients

[3] Cardiac is Adult and Pediatric.

[5] 3D/4D Imaging Mode.

[6] Includes imaging of guidance of biopsy (2D/3D/4D)

[7] Includes infertility monitoring of follicle development.

[8] Includes urology/prostate.

[9] Elastography imaging- Elasticity

[ • ] Combined mudes are B : M. B/Color M. B/PWD, B/Color/PWD, B/PWD

(PLEASE DO NOT WRITE BELOW THIS LINE - C'ONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiotogical Health (OIR)

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Image /page/9/Picture/0 description: The image shows a black and white logo. The logo is circular and contains the letters 'GE' in a stylized, intertwined font. The letters are white against a black background, and the circle is outlined in black.

### Diagnostic Ultrasound Indications for Use Form

#### GE Voluson S6/S8 with 4C-RS Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| | Mode of Operation | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|--------------------|---------------------|----------------|------------------|
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[Notes] |
| Ophthalmic | | | | | | | | | | | |
| Fetal (Obstetrics)[7] | P | P | P | | P | P | P | P | P | P | [6] |
| Abdominal[1] | P | P | P | | P | P | P | P | P | P | [6] |
| Pediatric | P | P | P | | P | P | P | P | P | P | [6] |
| Small Organ[2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac[1] | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | P | P | P | [6] |
| Musculo-skeletal Conventional | P | P | P | | P | P | P | P | P | P | [6] |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal[1] | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |

N - new indication. P - previously cleared by FDA

Notes |1} Abdominal includes renal, GYN:Pelvic

[2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatic and neonatal patients

[3] Cardiae is Adult and Pedialric

15| 31) 41) Imaging Mode

16| Includes imaging of guidance of bropsy (2D/3D).

| 7} Includes infertility monitoring of follicle development

|8] Includes urology/prostate

19] Elastography imaging- Elasticity

[*] Combined modes are B/M. B/Color M. B/PWD. B/Color/PWD, B/PWD

(PLEASE DO NOT WRITE BELUW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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Image /page/10/Picture/0 description: The image shows a logo of General Electric (GE). The logo consists of the letters "G" and "E" intertwined within a circular border. The letters and the border are in black, contrasting with the white background.

#### Diagnostic Ultrasound Indications for Use Form

#### GE Voluson S6/S8 with E8C-RS Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| | Mode of Operation | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|------------------|
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>(Noies) |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics[7] | P | P | P | | P | P | P | P | P | P | [6] |
| Abdominal[1] | P | P | P | | P | P | P | P | P | P | [6] |
| Pediatric | | | | | | | | | | | |
| Small Organ[2] | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | | P | P | P | P | P | P | [6] |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac[3] | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal[4] | P | P | P | | P | P | P | P | P | P | [6] |
| Transvaginal | P | P | P | | P | P | P | P | P | P | [6] |
| Transuretheral | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |

N = new indication: P = previously cleared by FDA

No1cs: { I } Abdominal includes renal, G YN/Pelvic

|2| Small organ includes hreast, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients

[3] Cardiac is Adult and Pediatric

[5] 3D/4D Imaging Mode.

[6] Includes imaging of guidance of biopsy (2D/3D/4D).

[7] Includes infertility monitoring of follicle development.

[8] Includes urology/prostate

[9] Elastography imaging. Elasticily

[ * ] Combined modes are B.M. B Color M. B:PWID. B:Color/PWD. BiPWD

(PI.E.ASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANDTHIER PAGE IF NEEDEDI

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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Image /page/11/Picture/0 description: The image shows a black and white logo. The logo is circular and contains the letters 'GE' in a stylized, intertwined font. The letters are enclosed within the circle, creating a recognizable brand symbol.

#### Diagnostic Ultrasound Indications for Use Form

### GE Voluson S6/S8 with C1-5-RS Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application<br><i>Anatomy/Region of Interest</i> | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>(Notes) |
|-----------------------------------------------------------|---|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics[1] | P | P | P | | P | P | P | P | P | P | [6] |
| Abdominal[1] | P | P | P | | P | P | P | P | P | P | [6] |
| Pediatric | P | P | P | | P | P | P | P | P | P | [6] |
| Small Organ[2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac[1] | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | P | P | P | | P | P | P | P | P | P | [6] |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal[1] | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |

N - new indication: P - previously cleared by FDA

Nolcs: [1] Abdominal includes renal, GYN/Pelvic

( 2 ) Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatic and neonalal pairens

[3] Cardiac is Adult and Pediatric

[5] 3D 4D Imaging Mode.

[6] Includes imaging of guidance of biopsy (2D/3D/4D).

[7] Includes infertility monitoring of follicle development.

[8] includes urology/prostate.

[9] Elastography imaging- Elasticity

[*] Combined modes are B/M. B/Color M. B/PWD, B/Color/PWD, B/PWD

(PLEASE DO NOT WRITE BELOW THIS LINE - ("ONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnoslics and Radiological Health (OIR)

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

Image /page/12/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The letters are enclosed within a circular border, giving the logo a classic and recognizable appearance.

#### Diagnostic Ultrasound Indications for Use Form

#### GE Voluson S6/S8 with 12L-RS Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application<br>Anatomy/Region of Interest | Mode of Operation | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|--------------------|---------------------|----------------|------------------|
| | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes' | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>(Notes) |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics1 | | | | | | | | | | | |
| Abdominal1 | | | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | P | P | P | [6,9] |
| Small Organ1 | P | P | P | | P | P | P | P | P | P | [6.9] |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac1 | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | P | P | P | [6,9] |
| Musculo-skeletal Conventional | P | P | P | | P | P | P | P | P | P | [6.9] |
| Musculo-skeletal Superficial | P | P | P | | P | P | P | P | P | P | [6.9] |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal1 | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |

N - new indication, P - previously cleared by FDA

| | | Abdominal includes renal, GYN/Pelvic Noics:

12) Small organ includes breast, thyroid, salvary gland, lymph nodes, pediatic and neonatal patients

| 3} Cardiac is Adult and Pediatric

15} 3D/4D Imaging Mode

16 | Includes imaging of guidance of bropsy (2D/3D/4D).

[7] Includes infertility monitoring of follsele development.

|8| Includes urology: prostate

19| Elastography smaging. Elasticity

(*) Combined modes are B/M, B/Color M, B/PWD, B/Color:PWD, B/PWD

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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

Image /page/13/Picture/0 description: The image shows a black and white logo of General Electric (GE). The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The letters are enclosed within a circular border that has a textured or patterned design, giving it a slightly vintage or classic appearance.

#### Diagnostic Ultrasound Indications for Use Form

#### GE Voluson S6/S8 with AB2-7-RS Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| | Mode of Operation | | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|--------------------|---------------------|----------------|------------------|--|
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>(Notes) | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal / Obstetrics1 | P | P | P | | P | P | P | P | P | P | [6] | |
| Abdominal1 | P | P | P | | P | P | P | P | P | P | [6] | |
| Pediatric | P | P | P | | P | P | P | P | P | P | [6] | |
| Small Organ1 | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac1 | | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | | |
| Musculo-skeletal Conventional | P | P | P | | P | P | P | P | P | P | [6] | |
| Musculo-skeletal Superficial | | | | | | | | | | | | |
| Other | | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal1 | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |

N = new indication: P = previously cleared by FDA

[1] Abdominal includes tenal, GYN/Pelvic Noics:

121 Small organ includes breast, testes. Ityroid, salivary gland, lymph nodes, pediatric and neonatal patients

[3] Cardiac is Adult and Pedialric

|5| 3D:4D imaging Mode.

16] Includes imaging of guidance of biopsy (2D/3D/4D)

[7] Includes infertility monitoring of follicle development.

[8] Includes urology: prostate.

{9| Elastography imaging- Flasticity

[*] Combined modes are B/M, B/Color M. B/PWD, B/Color/PWD, B/PWD

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Heath (OIR)

{14}------------------------------------------------

Image /page/14/Picture/0 description: The image shows a black and white logo. The logo is circular and contains the letters 'GE' in a stylized, intertwined font. The letters are white, and the background of the circle is black. The logo appears to be a vintage or classic design.

#### Diagnostic Ultrasound Indications for Use Form

### GE Voluson S6/S8 with RJC5-9W-RS Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application<br><i>Anatomy/Region of Interest</i> | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes1 | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>(Notes) |
|-----------------------------------------------------------|---|---|---------------|---------------|------------------|--------------------|------------------|--------------------|---------------------|----------------|------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics[7] | P | P | P | | P | P | P | P | P | P | [5,6,9] |
| Abdominal[1] | P | P | P | | P | P | P | P | P | P | [5,6,9] |
| Pediatric | | | | | | | | | | | |
| Small Organ[2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac[1] | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal[1] | P | P | P | | P | P | P | P | P | P | [5,6,9] |
| Transvaginal | P | P | P | | P | P | P | P | P | P | [5,6,9] |
| Transuretheral | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| | | | | | | | | | | | |

N = new indication: P = previously cleared by FDA

11

Noics: [1] Abdominal includes renal, G YN/Pelvic

[2] Small organ includes breast, thyroid, salivary gland, tymph nodes, pediatric and neonatal patients

|3] Cardiac is Adult and Pediatric.

|5] 3D/4D Imaging Mode.

[6] Includes imaging of guidance of biopsy (2D/3D/4D).

[7] Includes infertility monitoring of follicle development.

[8] Includes urology:/prostatc.

19] Elastography imaging- Elasticity

|* | Combined modes are B/M. B/Color M. B/PWD, B/Color/PWD, B/PWD

(PLEASE DO NOT WRITE DELLOW NISS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

{15}------------------------------------------------

Image /page/15/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The logo is in black and white, with the letters and border appearing in black against a white background.

#### Diagnostic Ultrasound Indications for Use Form

### GE Voluson S6/S8 with RAB2-S-RS Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| | Mode of Operation | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|------------|------------|---------------|-----------------|---------------|----------------|------------------|-------------|---------------|
| Clinical Application<br>Anatomy Region of Interest | B | M | PW Doppler | CW Doppler | Color Doppler | Color M Doppler | Power Doppler | Combined Modes | Harmonic Imaging | Coded Pulse | Other [Notes] |
| Ophthalmic | | | | | | | | | | | |
| Fetal (Obstetrics[7]) | P | P | P | | P | P | P | P | P | P | (5,6) |
| Abdominal[1] | P | P | P | | P | P | P | P | P | P | (5,6) |
| Pediatric | | | | | | | | | | | |
| Small Organ[2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac[3] | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | P | P | P | | P | P | P | P | P | P | (5,6) |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| Exam Type. Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal[4] | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |

N = new indication. P = previously cleared by FDA

| 1 | Abdominal includes renal, GYN:Pelvic Notes:

12) Small organ includes hreast, thyroid, salivary gland, lymph nodes, pediatic and neonatal patients

13) Cardiae is Adult and Pediatric

|5) 31) 41) Imaging Mode

16| Includes imaging of guidance of biopsy (2D 31)/4D).

17} Includes infertility monitoring of follicle development.

|8} Includes urology:/prosiate.

19] Elastography imaging- Elasticity

[*] Combined modes are B/M. B/Color M. B/PWD, B/Color/PWD, B/PWD

(PLEASE DO NOT WRITE BELOW THIS LINE . ('ONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

{16}------------------------------------------------

Image /page/16/Picture/0 description: The image shows a black and white logo of GE, which stands for General Electric. The logo is a circular shape with the letters "GE" intertwined in the center. The letters are stylized and have a flowing, cursive appearance. The logo is simple and recognizable, and it is often used to represent the company's brand.

#### Diagnostic Ultrasound Indications for Use Form

### GE Voluson S6/S8 with 8C-RS Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| | Mode of Operation | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|------------------|
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[Notes] |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics17 | P | P | P | | P | P | P | P | P | P | |
| Abdominal11 | P | P | P | | P | P | P | P | P | P | |
| Pediatric | P | P | P | | P | P | P | P | P | P | |
| Small Organ12 | P | P | P | | P | P | P | P | P | P | (9) |
| Neonatal Cephalic | P | P | P | | P | P | P | P | P | P | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac11 | P | P | P | | P | P | P | P | P | P | |
| Peripheral Vascular | P | P | P | | P | P | P | P | P | P | |
| Musculo-skeletal Conventional | P | P | P | | P | P | P | P | P | P | (9) |
| Musculo-skeletal Superficial | P | P | P | | P | P | P | P | P | P | (9) |
| Other | | | | | | | | | | | |
| Exam Type, Means of Acces…