VOLUSON I/E

K131937 · GE Healthcare · IYN · Sep 24, 2013 · Radiology

Device Facts

• Record ID: K131937
• Device Name: VOLUSON I/E
• Applicant: GE Healthcare
• Product Code: IYN · Radiology
• Decision Date: Sep 24, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal/OB; Abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatric; Small Organ (breast, testes, thyroid etc.); Cardiac (adult and pediatric); Musculoskeletal Conventional and Superficial; Peripheral Vascular; Transvaginal; Transrectal

Device Story

Voluson i/e is a portable, notebook-style diagnostic ultrasound system with integrated keyboard and color LCD. It supports linear, curved linear, and mechanical scanning transducers for B, M, PWD, Color, Color M, Amplitude Doppler, Harmonic Imaging, and Coded Pulse modes. Specialized motor-driven transducers and software enable 3D/4D volume imaging. Used in clinical settings by physicians or trained sonographers for general-purpose ultrasound imaging. The system includes comprehensive networking and DICOM capabilities. Output is displayed on the integrated screen for real-time visualization, measurement, and analysis, aiding clinicians in diagnosis and clinical decision-making across various anatomical regions. Benefits include high-performance imaging and volume analysis for improved diagnostic assessment.

Clinical Evidence

Bench testing only. No clinical studies were required to support substantial equivalence. The device was evaluated for acoustic output, biocompatibility, and electrical/mechanical safety, conforming to relevant standards (AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 2/3, ISO 10993-1).

Technological Characteristics

Portable notebook-style console with integrated keyboard and color LCD. Supports linear, curved linear, and mechanical scanning transducers. Modes: B, M, PWD, Color, Color M, Amplitude Doppler, Harmonic Imaging, Coded Pulse, 3D/4D. Connectivity: Networked, DICOM. Biocompatible patient-contact materials. Software includes SRI, XTD View, VCI, 4D-biopsy, STIC, HD-Flow, HD-Zoom, Volume Cine, SonoVCAD, SonoAVC, SonoNT, and SonoRenderStart.

Indications for Use

Indicated for diagnostic ultrasound imaging or fluid flow analysis in fetal/OB, abdominal (including GYN, pelvic, infertility monitoring), pediatric, small organ (breast, testes, thyroid, etc.), adult/pediatric cardiac, musculoskeletal (conventional/superficial), peripheral vascular, transvaginal, and transrectal 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 i Diagnostic Ultrasound System (K053435)
• Voluson E6/E8 E8 Expert/E10 Diagnostic Ultrasound System (K122327)
• Voluson S6/S8 Diagnostic Ultrasound System (K120741)
• Voluson P6/P8 Diagnostic Ultrasound System (K122387)

Submission Summary (Full Text)

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K131937
page 1 of 3

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 26. 2013 |
| Submitter: | GE Healthcare [GE Healthcare Austria GmbH & Co OG]<br>Tiefenbach 15<br>Zipf, Austria 4871 |
| Primary Contact Person: | Bryan Behn<br>Regulatory Affairs Manager<br>GE Healthcare<br>T:[phone]<br>F:[phone] |
| Secondary Contact Person: | Thomas Reisenberger<br>Regulatory Affairs Specialist<br>GE Healthcare Austria GmbH & Co OG<br>T:(++43)7682-3800-332<br>F:(++43)7682 3800-47<br>SEP 2 4 2013 |
| Device: Trade Name: | Voluson i/e Diagnostic Ultrasound System |
| Common/Usual Name: | Voluson i/e |
| Classification Names: | Class II |
| Product Code: | Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-1YN<br>Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO<br>Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX |
| Predicate Device(s): | K053435 Voluson i Diagnostic Ultrasound System<br>K122327 Voluson E6/E8 E8 Expert/E10 Diagnostic Ultrasound System<br>K120741 Voluson S6/S8 Diagnostic Ultrasound System<br>K122387 Voluson P6/P8 Diagnostic Ultrasound System |
| Device Description: | The Voluson i/e consists of a portable, notebook type console with integrated keyboard controls and color LCD display. It supports a variety of. It utilizes a variety of linear, curved linear transducers including mechanical scanning transducers supporting all standard acquisition modes (B, M. PWD, Color Color M and Amplitude Doppler modes, Harmonic Imaging and Coded Pulse). The Voluson i/e also utilizes motor driven transducers and image processing software that are specialized for 3D/4D volume imaging. It provides high performance ultrasound imaging and analysis and has comprehensive networking and DICOM capability. |

Image /page/0/Picture/4 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The letters are stylized in a cursive font, and the entire logo is presented in black and white.

:

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Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circle. The letters are stylized and connected, with the "G" looping around the "E". The logo is in black and white.

Additional probes and software features cleared on the predicate Device Modification: devices have been added.

> Addition of transducers - IC5-9W-RS (similar to IC5-9-D cleared on Voluson E Scries K122327), RAB2-6-RS (Cleared on Voluson P6/P8 K122387), 8C-RS (Cleared on Voluson S6/S8 K120741). Transducers added via Appendix E of "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers", issued September 9. 9L-RS, RAB4-8-RS, RNA5-9-RS and RIC5-9W-RS, 2008" AB2-7-RS and SP10-16-RS.

Software improvements migrated from predicate K122327:

SRI (Speckle Reduction Imaging), XTD View (Extended View) and VCI (Volume Contrast Imaging), 4D-biopsy, STIC (Spatial Temporal Image Correlation) HD-Flow (High Density Flow), HD- Zoom (High Density Zoom), Volume Cine, Sono VCAD, Sono AVC, SonoNT and SonoRenderStart

- The device is a general purpose ultrasound system. Specific Intended Use: clinical applications remain the same as previously cleared: Fetal/OB: Abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatric; Small Organ (breast, testes, thyroid etc.); Cardiac (adult and pediatric); Musculoskeletal Conventional and Superficial; Peripheral Vascular; Transvaginal: Transrectal
- The Voluson i/e employs the same fundamental scientific Technology: technology as its predicate devices.

Determination of Summary of Non-Clinical Tests:

Substantial Equivalence: 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 with applicable medical device safety standards. The Voluson i/e 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

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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" intertwined and enclosed within a circle. The letters and the circle are in black, contrasting with the white background.

K131937
Page 3 of 3

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
- 8. NEMA. Digital Imaging and Communications in Medicine (DICOM) Set. (Radiology)

The following quality assurance measures were 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 i/e, did not require clinical studies to support substantial equivalence.

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) of the United States. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is the HHS symbol, which features a stylized caduceus-like design with three parallel lines curving upwards.

Public Health Service

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

September 24, 2013

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

Re: K131937

Trade/Device Name: Voluson i/e Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Il Product Code: IYN, IYO, ITX Dated: June 26, 2013 Received: June 27, 2013

Dear Mr. Behn:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

This determination of substantial equivalence applies to the following transducers intended for use with the Voluson i/e, as described in your premarket notification:

#### Transducer Model Number

| RAB2-5-RS | RAB4-8-RS |
|------------|------------|
| RIC5-9-RS | RNA5-9-RS |
| RSP6-16-RS | AB2-7-RS |
| E8C-RS | 9L-RS |
| 4C-RS | SP10-16-RS |
| 12L-RS | RAB2-6-RS |
| RIC5-9W-RS | 8C-RS |
| IC5-9W-RS | |

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Page 2-Mr. Behn

If your device is classified (see above) into cither class II (Special Controls) or class III (PMA). it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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 (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 Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.html Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Pari 803), please go to

http://www.fda.gov/MedicalDevices/SafetyReportalProblem/default.htm for the CDRF'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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

lor

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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510(k) Number (if known): K131937

Voluson i/e Diagnostic Ultrasound System Device Name:

Indications for Use:

The device is a general purpose ultrasound system. Specific clinical applications include: Fetal/OB; Abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatric; Small Organ (breast, testes, thyroid etc.); Cardiac (adult and pediatric); Musculo-skeletal Conventional and Superficial; Peripheral Vascular; Transvaginal; Transrectal

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use_NA (Part 21 CFR 801 Subpart C)

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Image /page/6/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, circular design. The letters are surrounded by a decorative border, giving the logo a classic and recognizable appearance.

### Indications for Use Forms

The following forms represent indications with clinical applications and exam types along with the modes of operation for the Voluson i/e system and for all of its probe/mode combinations. Combinations identified by "N" are new while "P" represents those previously cleared with the unmodified Voluson i/e, P* indicates those added in this submission, but have clearance for the same modes and applications on another GE Ultrasound System. In a similar manner, "E" represents combinations added to the unmodified Voluson i/e via Appendix E of the FDA Ultrasound Guidance. This modification did not alter the previously cleared system level indications or clinical applications.

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#### Diagnostic Ultrasound Indications for Use Form GE Voluson i/e Ultrasound System

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 | [5,6] |
| Abdominal[1] | P | 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] | P | P | P | | P | P | P | P | P | P | [5,6] |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac[3] | P | P | P | P | P | P | P | P | P | P | [5] |
| Peripheral Vascular | P | P | P | | P | P | P | P | P | P | [5,6] |
| Musculo-skeletal<br>Conventional | P | P | P | | P | P | P | P | P | P | [5,6] |
| Musculo-skeletal<br>Superficial | P | P | P | | P | P | P | P | P | P | [5,6] |
| Other | | | | | | | | | | | |
| Exam Type, Means of<br>Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal[8] | P | P | P | | P | P | P | P | P | P | [5,6] |
| Transvaginal | P | P | P | | P | P | P | P | P | P | [5,6] |
| Transuretheral | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |

N = new indication: P = previously deared by FDA; E = added under Appendix E

Notes: [1] Abdominal Includes renal, GYN/Pelvic. Urology

[2] Small organ includes breast, thyroid, salivary gland, lymph nodes, podiatric and neonalal patients [3] Cardiac is Adull 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

["] Combined modes are BM, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

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Prescription User (Per 21 CFR 801.109)

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#### Diagnostic Ultrasound Indications for Use Form

### GE Voluson i/e with RAB2-5-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 | [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<br>Conventional | P | P | P | | P | P | P | P | P | P | [5,6] |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| Exam Type, Means of<br>Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal[4] | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |

N = new indication: P = previously cleared by FDA; E = added under Appendix E

Notes: (1) Abdominal includes renal, GYN/Pelvic, Urology

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

['] Combined modes are BM, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

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Prescription User (Per 21 CFR 801.109)

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Image /page/9/Picture/0 description: The image shows a logo with the letters 'GE' intertwined within a circular border. The letters are stylized and appear to be hand-drawn or calligraphic. The border is also decorative, with a swirling pattern that surrounds the letters. The logo is black and white.

### Diagnostic Ultrasound Indications for Use Form GE Voluson i/e with RIC5-9-RS Transducer

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 | | | | | | | | | | | |
| Fetal / Obstetrics[1] | P | P | P | | P | P | P | P | P | P | [5,6] |
| Abdominal[1] | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ[2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac[3] | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| Exam Type, Means of<br>Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal[6] | P | P | P | | P | P | P | P | P | P | [5,6] |
| Transvaginal | P | P | P | | P | P | P | P | P | P | [5,6] |
| Transuretheral | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |

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

Notes: [1] Abdominal includes renal, GYN/Pelvic, Urology

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

[3] Cardiac is Adull and Pediatric.

[5] 3D/4D Imaging Mode

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

171 Includes infertill;y monitoring of follicle development

{8} Includes urology/prostate

[1] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

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

Prescription User (Per 21 CFR 801.109)

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Image /page/10/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 within a circular border. The design is intricate and stylized, with the letters having a flowing, cursive appearance. The logo is a recognizable symbol of the General Electric company.

# Diagnostic Ultrasound Indications for Use Form

### GE Voluson ile with RSP6-16-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[1] | | | | | | | | | | | |
| Abdominal[1] | | | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | P | P | P | [5,6] |
| Small Organ[2] | P | P | P | | P | P | P | P | P | P | [5,6] |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac[3] | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | P | P | P | [5,6] |
| Musculo-skeletal<br>Conventional | P | P | P | | P | P | P | P | P | P | [5,6] |
| Musculo-skeletal Superficial | P | P | P | | P | P | P | P | P | P | [5,6] |
| Other | | | | | | | | | | | |
| Exam Type, Means of<br>Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal[6] | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |

N = new indication: P = previously cleared by FDA; E = added under Appendix E

Notes: [1] Abdominal includes ranal, GYN/Pelvic, Urology

[2] Small organ includes breast, thyroid, salvary gland, lymph nodes, pediative and neonatal palients

[3] Cardiac is Adult and Pediatric.

[5] 3D/4D Imaging Mode

(6) Includes imaging of guldance of biopsy (20/3D/4D)

[7] Includes Infertility monitoring of follicle development

[8] Includes urology/prosiale

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

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

Prescription User (Per 21 CFR 801.109)

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#### Diagnostic Ultrasound Indications for Use Form

#### GE Voluson i/e 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>(Notes) | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal / Obstetrics[1] | P | P | P | | P | P | P | P | P | P | [6] | |
| Abdominal[1] | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ[2] | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac[3] | | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | | |
| Other | | | | | | | | | | | | |
| Exam Type, Means of<br>Access | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal[8] | P | P | P | | P | P | P | P | P | P | [6] | |
| Transvaginal | P | P | P | | P | P | P | P | P | P | [6] | |
| Transuretheral | | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |

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

Notes: . [1] Abdominal Includes renal, GYN/Pelvic, Urology

12) Small organ includes breast, testes. Ihyrold, salivary gland, lymph nodes, pediatic and naonatal 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

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/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)

Prescription User (Per 21 CFR 801.109)

Page 6 of 17

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

Image /page/12/Picture/0 description: The image shows a black and white logo. The logo is circular and contains the letters 'GE' intertwined in a stylized, cursive font. The letters are surrounded by a decorative border, also in black and white, which gives the logo a vintage or classic appearance.

#### Diagnostic Ultrasound Indications for Use Form

#### GE Voluson i/e with 4C-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 / 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[3] | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | P | P | P | [8] |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| Exam Type, Means of<br>Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal[4] | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |

N = new indication: P = previously deared by FDA; E = added under Appendlx E

Notes: [1] Abdominal Includes renal, GYN/Pelvic, Urology

(2) Small organ includes breast, lestes, thyrold, salivary gland, lymph nodes, pediatric and neonatal patients [3] Cardiac Is Adult and Pediatric.

[5] 3D/4D Imaging Mode

161 Includes imaging of guidance of biopsy (20/3D/4D)

[7] Includes infertility monitoring of follicle development

[8] Includes urology/prostate

['] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/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 (OJR)

Prescription User (Per 21 CFR 801.109)

Page 7 of 17

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

Image /page/13/Picture/0 description: The image shows a logo with the letters 'GE' intertwined within a circular border. The letters are stylized and ornate, with flowing curves and decorative elements. The border surrounding the letters is also decorative, featuring a pattern of small, repeating shapes. The logo is black and white.

#### Diagnostic Ultrasound Indications for Use Form

### GE Voluson i/e with 12L-RS Transducer

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

| | Mode of Operation | | | | | | | | | | | | |
|----------------------------------|-------------------|---|---------|---------|---------|---------|---------|----------|----------|-------|---------|--|--|
| Clinical Application | ਉ | ખ | PW | CW | Color | Color M | Power | Combined | Harmonic | Coded | Other | | |
| Anatomy/Region of Interest | | | Doppler | Doppler | Doppler | Doppler | Ooppler | Modes | Imaging | Pulse | (Notes) | | |
| Ophthalmic | | | | | | | | | | | | | |
| Fetal / Obsteirics 17 | | | | | | | | | | | | | |
| Abdominal 11 | | | | | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | P | P | b | (1 | | |
| Small Organ 21 | P | P | P | | P | P | P | P | P | P | ( €) | | |
| Neonatal Cephalic | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | |
| Cardiada | | | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | P | P | P | ા | | |
| Musculo-skeletal<br>Conventional | p | P | P | | P | P | P | p | P | P | ા છે | | |
| Musculo-skelatal<br>Superficial | P | P | P | | P | P | P | P | D | P | ાં છો | | |
| Other | | | | | | | | | | | | | |
| Exam Type, Means of<br>Access | | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | | |
| Transrectare) | | | | | | | | | | | | | |
| Transvagina! | | | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | |

N = new Indication: P = previously cleared by FDA; E = added under Appendix E

Notes: [1] Abdominal includes renal, GYN/Pelvic, Urology

(2) Small organ includes breast, thyroid, salivary gland, lymph nodes, pediatric and neonalal pattents [3] Cardiac is Adult and Pediatric.

[5] 3D/4D Imaging Mode

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

[7] Includes infertility monitoring of follicle development

[8] Includes urology/prostate

["] Combined modes are BM, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/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)

Prescription User (Per 21 CFR 801.109)

Page 8 of 17

K131937

ટરૂ

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

### Diagnostic Ultrasound Indications for Use Form

### GE Voluson i/e with RIC5-9W-RS Transducer

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 | | | | | | | | | | | |
| Fetal / Obstetrics[1] | E | E | E | | E | E | E | E | E | E | [5,6] |
| Abdominal[1] | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ[2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac[3] | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| Exam Type, Means of<br>Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal[4] | E | E | E | | E | E | E | E | E | E | [5,6] |
| Transvaginal | E | E | E | | E | E | E | E | E | E | [5,6] |
| Transuretheral | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |

N a new indication; P = previously cleared by FDA; E = added under Appendix E (previously cleared Voluson S6/SB K120741)

Notes: [1] Abdominal includes renal, GYN/Pelvic, Urology

[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 infertifity monitoring of follicle development

[8] Includes urology/prostate

["] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/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)

Prescription User (Per 21 CFR 801.109)

Page 9 of 17

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

Image /page/15/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, circular design. The letters are surrounded by a decorative border, giving the logo a vintage or classic appearance.

#### Diagnostic Ultrasound Indications for Use Form

#### GE Voluson ife with IC5-9W-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) | N | N | N | | N | N | N | N | N | N | [6] |
| Abdominal(1) | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ(2) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac(3) | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| Exam Type. Means of<br>Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal(4) | N | N | N | | N | N | N | N | N | N | [6] |
| Transvaginal | N | N | N | | N | N | N | N | N | N | [6] |
| Transuretheral | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |

N = new Indicallon; P = previously cleared by FDA; E = added under Appendix E

Notes: [1] Abdominal includes renal, GYN/Pelvic, Urology

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

[…