VOLUSON E6/E8/E8EXPERT/E8EXPERT LIMITED EDITION/E10

K131267 · GE Healthcare · IYN · Jun 19, 2013 · Radiology

Device Facts

• Record ID: K131267
• Device Name: VOLUSON E6/E8/E8EXPERT/E8EXPERT LIMITED EDITION/E10
• Applicant: GE Healthcare
• Product Code: IYN · Radiology
• Decision Date: Jun 19, 2013
• Decision: SESE
• Submission Type: Special
• 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.); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Musculo-skeletal Conventional and Superficial; Peripheral Vascular; Transvaginal; Transrectal

Device Story

Voluson E-Series is a mobile, full-featured Track 3 diagnostic ultrasound system for general radiology and OB/GYN. It acquires ultrasound signals via linear, curved linear, and matrix phased array transducers. The system processes these signals to produce 2D, 3D, and 4D images, as well as Doppler flow analysis. Operated by clinicians in clinical settings, it features a keyboard, touch panel, and display for real-time visualization. It supports DICOM networking for image storage and management. The device provides high-performance imaging and analysis to assist in clinical decision-making for various anatomical regions. Benefits include enhanced diagnostic capabilities through real-time 3D/4D acquisition and specialized imaging modes, aiding in patient assessment and monitoring.

Clinical Evidence

No clinical data required. Substantial equivalence supported by non-clinical bench testing, including acoustic output measurements, biocompatibility, thermal/electrical/mechanical safety, and electromagnetic compatibility testing.

Technological Characteristics

Mobile ultrasound console with keyboard, touch panel, and display. Utilizes linear, curved linear, and matrix phased array transducers. Features include 3D/4D acquisition, Doppler (PW, CW, Color, Power), and harmonic imaging. Complies with AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, NEMA UD 2/UD 3, and ISO 10993-1. Connectivity via DICOM. Software includes STIC, HDLive, and SonoRenderstart.

Indications for Use

Indicated for diagnostic ultrasound imaging or fluid flow analysis in fetal/OB, abdominal, pediatric, small organ, neonatal/adult cephalic, cardiac, musculoskeletal, peripheral vascular, transvaginal, and transrectal applications. Prescription use only.

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 E6/E8/E8Expert/E10 Diagnostic Ultrasound System (K122327)
• Voluson S6/S8 Diagnostic Ultrasound System (K120741)

Submission Summary (Full Text)

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JUN 1 9 2013

K131267
Page 1 of 3

510(k) Premarket Notification Submission

## 510(k) Summary

: 上

| In accordance with 21 CFR 807.92 the following summary of information is provided: | |
|------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | May 2, 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: | Roland Kuntscher<br>Regulatory Affairs Specialist<br>GE Healthcare Austria GmbH & Co OG<br>T:(++43)7682-3800-660<br>F:(++43)7682 3800-47 |
| Device: | Voluson E Series<br>Trade Name: |
| | Models: Voluson E6/E8/E8Expert/E8Expert Limited Edition/<br>E10 Diagnostic Ultrasound Systems |
| Common/Usual Name: | Voluson E6/E8/E8Expert/E8Expert Limited Edition/E10 |
| Classification Names: | Class II |
| Product Code: | Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-IYN<br>Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO<br>Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX |
| Predicate Device(s): | K122327 Voluson E6/E8/E8Expert/E10 Diagnostic Ultrasound<br>System |
| | K120741 Voluson S6/S8 Diagnostic Ultrasound System |
| Device Description: | The Voluson E-Series system is a full-featured Track 3<br>ultrasound system, primarily for general radiology use and<br>specialized for OB/GYN with particular features for realtime<br>3D/4D acquisition. It consists of a mobile console with keyboard<br>control panel; color LCD/TFT touch panel, color video display<br>and optional image storage and printing devices. It provides high<br>performance ultrasound imaging and analysis and has<br>comprehensive networking and DICOM capability. It utilizes a<br>variety of linear, curved linear, matrix phased array transducers<br>including mechanical and electronic scanning transducers, which<br>provide highly accurate realtime three dimensional imaging<br>supporting all standard acquisition modes. |

Image /page/0/Picture/5 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circle. The letters and the inner part of the circle are black, while the outer ring of the circle is white.

40

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## GE Healthcare

#### 510(k) Premarket Notification Submission

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.); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Musculo-skeletal Conventional and Superficial; Peripheral Vascular; Transvaginal; Transrectal Voluson E-Series will provide new Power Supply (Wide Range), Device Modification: new Beamformer (Integrated circuit) and new ECG-Module (Hardware option) from the Voluson S6/S8 (K120741). There have also been minor software improvements to a few existing software features e STIC (Spatial Temporal Image Correlation), HDLive (HD Live II), SonoRenderstart (SonoRendersstart II) and Cine Loop (Start/Length). The Voluson E-Series employs the same fundamental scientific Technology: technology as its predicate devices.

Summary of Non-Clinical Tests: Determination of 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 E-Series and its applications comply with voluntary standards:

- 1. 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

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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 E Series, did not require clinical studies to support substantial equivalence.

GE Healthcare considers the Voluson E Series 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 U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

#### Public Health Service

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

June 19, 2013

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

Re: K131267

Trade/Device Name: Voluson E6/E8/E8Expert/E8Expert Limited Edition/E10 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: May 31, 2013 Received: June 3, 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 E6/E8/E8Expert/E8Expert Limited Edition/E10, as described in your premarket notification:

| | Transducer Model Number | |
|-----------|-------------------------|-----------|
| RAB2-5-D | 9L-D | RRE5-10-D |
| RIC5-9-D | P2D | RM14L |
| RNA5-9-D | P6D | 3Sp-D |
| 4C-D | 11L-D | C4-8-D |
| IC5-9-D | C1-5-D | RAB6-D |
| RSP6-16-D | ML6-15-D | eM6C |
| RIC6-12-D | RM6C | S4-10-D |

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Page 2-- Mr. Behn

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/McdicalDevices/Safety/ReportaProblem/dcfault.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 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,—

Sm. 7)

Janine M. Morris 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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#### 510(k) Number (if known): K131267

Device Name: Voluson E-Series (Voluson E6/E8/E8Expert/E8Expert Limited Edition/E10) Diagnostic Ultrasound Systems

Indications for Use:

The device is a general purpose ultrasound system. Specific 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.); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Musculoskeletal 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)

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

-Concurrence of-GDRI-1,-Office of-In-Vitro-Diagnostics and-Radiological-Health-(OIR)-

Page 1 of 23

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## Indications for Use Forms

The following forms represent indications with clinical applications and exam types along with the modes of operation for the Voluson E Series system and for all of its probe/mode combinations. Combinations identified as "P" represents those previously cleared with the unmodified Voluson E6/E8/E8Expert/E10 and "E" are those that have been added by Appendix E of the FDA Ultrasound guidance. This modification did not add to the previously cleared system level.or transducer indications or clinical applications.

Confidential and Privileged. This document contains confidential and priviteged trade scerets and other information of General Electric Co. and as such may not be disclosed to others not employed by General Hectric Co. All rights reserved

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#### Diagnostic Ultrasound Indications for Use Form GE Voluson E-Series (Voluson E6/E8/E8Expert/E8Expert Limited Edition/E10)

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 | 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 Organ21 | 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[8] | 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; E = added under Appendix E

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

> (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.

f61 Includes imaging of quidance of biopsy (2D/3D/4D).

[7] Includes infertility monitoring of follicle development.

[8] Includes urology/prostate.

[9] Elastography imaging- Elasticity

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

[*] 4D color Doppler

(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)

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#### Diagnostic Uitrasound Indications for Use Form

#### GE Voluson E Series with RAB2-5-D 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 | E | P | P | P | P | P | P | [5,6] |
| Abdominal11 | P | P | P | E | P | P | P | P | P | P | [5,6] |
| Pediatric | | | | | | | | | | | |
| Small Organ(2) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac11 | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | P | P | P | E | P | P | P | P | P | P | [5,6] |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |

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

Notes [1] Abdominal includes renal, GYN/Pelvic

[5] 3D/4D Imaging Mode

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

[7] Includes infertility monitoring of follicle development

{*] 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)

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## Diagnostic Ultrasound Indications for Use Form

#### GE Voluson E Series with RIC5-9-D 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<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[71] | P | P | P | | P | P | P | P | P | P | [5,6,9] |
| Abdominal[1] | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (2) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac (3) | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| Exam Type. Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal[8] | 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 | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |

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

|5| 3D/4D Imaging Mode Notes:

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

{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 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)

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#### Diagnostic Ultrasound Indications for Use Form

#### GE Voluson E Series with RNA5-9-D 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 | 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 | P | [5.6] | |
| Small Organ[2] | P | P | P | P | P | P | P | P | P | P | [5,6] | |
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | P | [5] | |
| Adult Cephalic | | | | | | | | | | | | |
| 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] | |
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | P | P | P | [5.6] | |
| Musculo-skeletal Superficial | | | | | | | | | | | | |
| Other | | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal[8] | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | | |
| -- Intraoperative Neurological-- | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |

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

Notes: [1] Abdominal is Neonatal and pediatric

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

[3] Cardiac is Neonatal and Pediatric.

[5] 3D/4D Imaging Mode

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

[*] 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 5 of 23

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Image /page/11/Picture/15 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a circular design. The logo is black and white.

## Diagnostic Ultrasound Indications for Use Form GE Voluson E Series with 4C-D 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<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 / Obstetrics171 | P | P | P | P | P | P | P | P | P | P | [6] |
| Abdominal111 | P | P | P | P | P | P | P | P | P | P | [6] |
| Pediatric | | | | | | | | | | | |
| Small Organ121 | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac131 | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | P | [6] |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |

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

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

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

[7] Includes infertility monitoring of follicle development

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

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Page 6 of 23

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Image /page/12/Picture/0 description: The image shows the General Electric (GE) logo, which consists of the letters 'G' and 'E' intertwined within a circular border. The letters are stylized and connected in a cursive-like manner. The logo is black and white, with the letters and border appearing in black against a white background.

## Diagnostic Ultrasound Indications for Use Form GE Voluson E Series with IC5-9-D 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 | [6,9] |
| Abdominal[1] | | | | | | | | | | | |
| 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[8] | P | P | P | | P | P | P | P | P | P | [6,9] |
| Transvaginal | P | P | P | | P | P | P | P | P | P | [6,9] |
| Transuretheral | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |

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

[6] Includes imaging of guidance of biopsy (2D) Notes:

[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 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)

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Page 7 of 23

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Image /page/13/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 letters are stylized with curved lines and loops, giving the logo a distinctive and recognizable appearance.

# GE Healthcare

510(k) Premarket Notification Submission

## Diagnostic Ultrasound Indications for Use Form

#### GE Voluson E Series with RSP6-16-D 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] | | | | | | | | | | | |
| 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 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 Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal[8] | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| -Intraoperative-Neurological- | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |

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

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

[5] 3D/4D Imaging Mode (6) Includes imaging of guidance of biopsy (3D/4D)

[*] 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)

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Page 8 of 23

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Image /page/14/Picture/0 description: The image shows the General Electric (GE) logo, which consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The letters are enclosed within a circular border. The logo is presented in black and white, with the letters and border appearing in black against a white background.

## Diagnostic Ultrasound Indications for Use Form GE Voluson E Series with RIC6-12-D Transducer

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

| | Mode of Operation | | | | | | | | | | | |
|-------------------------------|-------------------|---|---------|---------|---------|---------|---------|-------|-------------------|-------|---------|--|
| Clinical Application | B | M | PW | CW | Color | Color M | Power | | Combined Harmonic | Coded | Other | |
| Anatomy/Region of Interest | | | Doppler | Doppler | Doppler | Doppler | Doppler | Modes | Imaging | Pulse | [Notes) | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal / Obstetrics171 | P | P | P | | P | P | P | P | P | P | ( 5,6) | |
| Abdomina]™ | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organizi | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac™ | | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | | |
| Other | | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectall&i | P | P | P | | P | b | b | P | P | P | ( 5,6) | |
| Transvaginal | P | P | P | | P | P | P | P | P | P | 5.61 | |
| Transuretheral | | | | | | | | | | | | |
| -Intraoperative | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |

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

[5] 3D/4D Imaging Mode Notes:

[6] Includes imaging of guidance of biopsy (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 9 of 23

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## Diagnostic Ultrasound Indications for Use Form GE Voluson E Series with 9L-D Transducer

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

| | Mode of Operation | | | | | | | | | | | |
|-------------------------------|-------------------|---|---------|---------|---------|---------|---------|----------|----------|-------|---------|--|
| Clinical Application | B | M | PW | CW | Color | Color M | Power | Combined | Harmonic | Coded | Other | |
| Anatomy/Region of Interest | | | Doppler | Doppler | Doppler | Doppler | Doppler | Modes | Imaging | Pulse | (Notes) | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal / Obstetrics171 | | | | | | | | | | | | |
| Abdominal™ | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | P | P | P | [୧] | |
| Small Organ 21 | P | P | P | P | P…