K Number
K142472
Device Name
Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound Systems
Manufacturer
Date Cleared
2015-02-10

(160 days)

Product Code
Regulation Number
892.1550
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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); Musculo-skeletal Conventional and Superficial; Peripheral Vascular; Transvaginal (including GYN); Transrectal
Device Description
The systems are full-featured Track 3 ultrasound systems, primarily for general radiology use and specialized for OB/GYN with particular features for realtime 3D/4D acquisition. They consist of a mobile console with keyboard control panel; color LCD/TFT touch panel, color video display and optional image storage and printing devices. They provide high performance ultrasound imaging and analysis and have comprehensive networking and DICOM capability. They utilize a variety of linear, curved linear, matrix phased array transducers including mechanical and electronic scanning transducers, which provide highly accurate realtime three dimensional imaging supporting all standard acquisition modes.
More Information

No
The document does not mention AI, ML, or related terms, and the description focuses on standard ultrasound technology and features.

No.
The device is described as an ultrasound imaging system ("diagnostic ultrasound system") used for visualization and analysis, not for treating conditions.

Yes

The "Intended Use / Indications for Use" section lists multiple clinical applications for which the device is used, such as "Fetal/OB," "Abdominal," "Cardiac," and "Musculo-skeletal." These are areas where medical conditions are diagnosed. Furthermore, the "Predicate Device(s)" explicitly names a "Diagnostic Ultrasound System," strongly suggesting a diagnostic purpose for the subject device.

No

The device description explicitly states it consists of a mobile console with keyboard control panel, color LCD/TFT touch panel, color video display, optional image storage and printing devices, and utilizes a variety of transducers, indicating it is a hardware system with integrated software, not a software-only device.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
  • Device Description: The description clearly states that this is a "general purpose ultrasound system." Ultrasound is an imaging modality that uses sound waves to create images of internal body structures. It does not involve testing samples taken from the body.
  • Intended Use/Indications for Use: The listed applications are all related to imaging internal anatomy (Fetal/OB, Abdominal, Cardiac, etc.). These are typical applications for an ultrasound system, not an IVD.
  • Lack of IVD-related information: The document does not mention any analysis of biological samples, reagents, or laboratory procedures, which are characteristic of IVD devices.

Therefore, this device falls under the category of a medical imaging device, not an in vitro diagnostic device.

N/A

Intended Use / 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); Musculo-skeletal Conventional and Superficial; Peripheral Vascular; Transvaginal (including GYN); Transrectal

Product codes

IYN, IYO, ITX

Device Description

The systems are full-featured Track 3 ultrasound systems, primarily for general radiology use and specialized for OB/GYN with particular features for realtime 3D/4D acquisition. They consist of a mobile console with keyboard control panel; color LCD/TFT touch panel, color video display and optional image storage and printing devices. They provide high performance ultrasound imaging and analysis and have comprehensive networking and DICOM capability. They utilize a variety of linear, curved linear, matrix phased array transducers including mechanical and electronic scanning transducers, which provide highly accurate realtime three dimensional imaging supporting all standard acquisition modes.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Diagnostic ultrasound imaging or fluid flow analysis

Anatomical Site

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 (including GYN); Transrectal

Indicated Patient Age Range

Adult and Pediatric

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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. The Voluson E Series and its applications comply with voluntary standards:

    1. AAMI/ANSI ES60601-1, Medical Electrical Equipment – Part 1: General Requirements for Safety
    1. IEC60601-1-2, Medical Electrical Equipment -Part 1-2:General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility Requirements and Tests
    1. IEC60601-2-37, Medical Electrical Equipment -Part 2-37:Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment
    1. NEMA UD 3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
    1. ISO10993-1, Biological Evaluation of Medical Devices- Part 1: Evaluation and Testing
    1. NEMA UD 2, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
    1. ISO14971. Application of risk management to medical devices
    1. 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)
  • Performance testing (Verification)
  • Safety testing (Verification)

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K132913

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
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.(b)
Classification. Class II.

0

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

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

February 10, 2015

GE Healthcare % Ms. Tracey Ortiz Regulatory Affairs Director 9900 W. Innovation Drive WAUWATOSA WI 53226

Re: K142472

Trade/Device Name: Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound Systems Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: January 13, 2015 Received: January 14, 2015

Dear Ms. Ortiz:

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 / Voluson E8 / Voluson E10. as described in your premarket notification:

Transducer Model Number

RAB2-5-DRIC5-9-DRNA5-9-D4C-D
IC5-9-DRSP6-16-DRIC6-12-D9L-D
P2DP6D11L-DC1-5-D
ML6-15-DRM6C3Sp-DC4-8-D
RAB6-DeM6CS4-10-D

1

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 Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours,

Robert A Ochs

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

Enclosure

2

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known)

K142472

Device Name

Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound Systems

Indications for Use (Describe)

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); Musculo-skeletal Conventional and Superficial; Peripheral Vascular; Transvaginal (including GYN); Transrectal

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

Prescription Use (Part 21 CFR 801 Subpart D)

  • Over-The-Counter

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)

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This section applies only to requirements of the Paperwork Reduction Act of 1995.

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

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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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 another GE Ultrasound system. This modification does not add to indications to the previously cleared system level or transducer indications or clinical applications.

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Diagnostic Ultrasound Indications for Use Form GE Voluson E Series

(Voluson E6 / Voluson E8 / Voluson E10)

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

| Clinical Application
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 | 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 | [ 5 ] |
| Cardiac[3] | 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[10] | 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, 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

[7] Includes infertility monitoring of follicle development

[8] Includes urology/prostate

[9] Elastography imaging- Elasticity

[10] Transvaginal includes GYN

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

[*] 4D color Doppler (only with eM6C probe)

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

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Diagnostic Ultrasound 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
Anatomy/Region of InterestBMPW DopplerCW DopplerColor DopplerColor M DopplerPower DopplerCombined Modes*Harmonic ImagingCoded PulseOther [Notes]
Ophthalmic
Fetal / Obstetrics[7]PPPPPPPPPP[ 5,6]
Abdominal[1]PPPPPPPPPP[ 5,6]
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletal ConventionalPPPPPPPPPP[ 5,6]
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
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

[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)

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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
Anatomy/Region of InterestBMPW
DopplerCW
DopplerColor
DopplerColor M
DopplerPower
DopplerCombined
ModesHarmonic
ImagingCoded
PulseOther
[Notes]
Ophthalmic
Fetal / Obstetrics[7]PPPPPPPPP[ 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]PPPPPPPPP[ 5,6,9]
Transvaginal[10]PPPPPPPPP[ 5,6,9]
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

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

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

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

[7] Includes infertility monitoring of follicle development

[8] Includes urology/prostate

[9] Elastography Imaging- Elasticity

[10] Transvaginal includes GYN

[*] 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)

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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
Anatomy/Region of InterestBMPW DopplerCW DopplerColor DopplerColor M DopplerPower DopplerCombined Modes*Harmonic ImagingCoded PulseOther [Notes]
Ophthalmic
Fetal / Obstetrics[7]PPPPPPPPPP[5,6]
Abdominal[1]PPPPPPPPPP[5,6]
PediatricPPPPPPPPPP[5,6]
Small Organ[2]PPPPPPPPPP[5,6]
Neonatal CephalicPPPPPPPPPP[5]
Adult Cephalic
Cardiac[3]PPPPPPPPPP[5]
Peripheral VascularPPPPPPPPPP[5,6]
Musculo-skeletal ConventionalPPPPPPPPPP[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

[1] Abdominal is Neonatal and pediatric Notes:

[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)

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Image /page/9/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' written in a stylized script, enclosed within a blue circle. The circle has a swirling pattern around the letters, giving it a dynamic and recognizable appearance.

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
Anatomy/Region of InterestBMPW
DopplerCW
DopplerColor
DopplerColor M
DopplerPower
DopplerCombined
Modes*Harmonic
ImagingCoded
PulseOther
[Notes]
Ophthalmic
Fetal / Obstetrics[7]PPPPPPPPPP[6]
Abdominal[1]PPPPPPPPPP[6]
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral VascularPPPPPPPPPP[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

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

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Image /page/10/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a blue circle. The blue circle has a white border and a few white accents that give the impression of movement or energy around the letters.

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
Anatomy/Region of InterestBMPW DopplerCW DopplerColor DopplerColor M DopplerPower DopplerCombined
Modes*Harmonic ImagingCoded PulseOther [Notes]
Ophthalmic
Fetal / Obstetrics[7]PPPPPPPPP[ 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]PPPPPPPPP[ 6,9]
Transvaginal[10]PPPPPPPPP[ 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

[10] Transvaginal includes GYN

[*] 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)

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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
Anatomy/Region of InterestBMPW
DopplerCW
DopplerColor
DopplerColor M
DopplerPower
DopplerCombined
Modes*Harmonic
ImagingCoded
PulseOther
[Notes]
Ophthalmic
Fetal / Obstetrics[7]
Abdominal[1]
PediatricPPPPPPPPP[5,6]
Small Organ[2]PPPPPPPPP[5,6]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral VascularPPPPPPPPP[5,6]
Musculo-skeletal ConventionalPPPPPPPPP[5,6]
Musculo-skeletal SuperficialPPPPPPPPP[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, testes, 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)

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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 ApplicationBMPW
DopplerCW
DopplerColor
DopplerColor M
DopplerPower
DopplerCombined
Modes*Harmonic
ImagingCoded
PulseOther
[Notes]
Anatomy/Region of Interest
Ophthalmic
Fetal / Obstetrics[7]PPPPPPPPP[5,6]
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]PPPPPPPPP[5,6]
Transvaginal[10]PPPPPPPPP[5,6]
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

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

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

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

[7] Includes infertility monitoring of follicle development

[8] Includes urology/prostate

[10] Transvaginal includes GYN

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

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13

Image /page/13/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized script inside. The letters are also blue, and they are surrounded by a swirling pattern. The logo is simple and recognizable, and it is associated with a well-known company.

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
Anatomy/Region of InterestBMPW
DopplerCW
DopplerColor
DopplerColor M
DopplerPower
DopplerCombined
Modes*Harmonic
ImagingCoded
PulseOther
[Notes]
Ophthalmic
Fetal / Obstetrics[7]PPPPPPPPPP[6]
Abdominal[1]
PediatricPPPPPPPPPP[6]
Small Organ[2]PPPPPPPPPP[6]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral VascularPPPPPPPPPP[6]
Musculo-skeletal ConventionalPPPPPPPPPP[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

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

[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

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

14

Image /page/14/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized script inside. The letters are also blue, and they are surrounded by a swirling pattern. The logo is simple and recognizable, and it is associated with a well-known company.

Diagnostic Ultrasound Indications for Use Form

GE Voluson E Series with P2D Transducer

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

| Clinical Application
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] | | | | | | | | | | | |
| Abdominal[1] | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ[2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | P | | | | | | | |
| Cardiac[3] | | | | P | | | | | | | |
| Peripheral Vascular | | | | P | | | | | | | |
| 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: [3] Cardiac is adult and Pediatric

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15

Image /page/15/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized script inside. The letters are also blue, and they are surrounded by a swirling pattern. The logo is simple and recognizable, and it is associated with a well-known company.

Diagnostic Ultrasound Indications for Use Form

GE Voluson E Series with P6D Transducer

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

Mode of Operation
Clinical Application
Anatomy/Region of InterestBMPW
DopplerCW
DopplerColor
DopplerColor M
DopplerPower
DopplerCombined
Modes*Harmonic
ImagingCoded
PulseOther
[Notes]
Ophthalmic
Fetal / Obstetrics[7]
Abdominal[1]
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]P
Peripheral VascularP
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: [3] Cardiac is adult and Pediatric

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

16

Image /page/16/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a blue circle. The blue circle has a white border and a few white accents that give the impression of movement or energy around the letters.

Diagnostic Ultrasound Indications for Use Form

GE Voluson E Series with 11L-D Transducer

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

Mode of Operation
Clinical Application
Anatomy/Region of InterestBMPW
DopplerCW
DopplerColor
DopplerColor M
DopplerPower
DopplerCombined
Modes*Harmonic
ImagingCoded
PulseOther
[Notes]
Ophthalmic
Fetal / Obstetrics[7]
Abdominal[1]
PediatricPPPPPPPPP[6,9]
Small Organ[2]PPPPPPPPP[6,9]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral VascularPPPPPPPPP[6,9]
Musculo-skeletal ConventionalPPPPPPPPP[6,9]
Musculo-skeletal SuperficialPPPPPPPPP[6,9]
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

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

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

[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)

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Diagnostic Ultrasound Indications for Use Form

GE Voluson E Series with C1-5-D Transducer

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

Mode of Operation
Clinical Application
Anatomy/Region of InterestBMPW
DopplerCW
DopplerColor
DopplerColor M
DopplerPower
DopplerCombined
Modes*Harmonic
ImagingCoded
PulseOther
[Notes]
Ophthalmic
Fetal / Obstetrics[7]PPPPPPPPPP[6]
Abdominal[1]PPPPPPPPPP[6]
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral VascularPPPPPPPPPP[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

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

[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

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

18

Image /page/18/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized script inside. The letters are also blue, and they are surrounded by a swirling pattern. The logo is simple and recognizable, and it is associated with a well-known company.

Diagnostic Ultrasound Indications for Use Form

GE Voluson E Series with ML6-15-D Transducer

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

Mode of Operation
Clinical Application
Anatomy/Region of InterestBMPW
DopplerCW
DopplerColor
DopplerColor M
DopplerPower
DopplerCombined
Modes*Harmonic
ImagingCoded
PulseOther
[Notes]
Ophthalmic
Fetal / Obstetrics[7]
Abdominal[1]
PediatricPPPPPPPPP[6,9]
Small Organ[2]PPPPPPPPP[6,9]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral VascularPPPPPPPPP[6,9]
Musculo-skeletal ConventionalPPPPPPPPP[6,9]
Musculo-skeletal SuperficialPPPPPPPPP[6,9]
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

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

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

[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)

19

Image /page/19/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized script inside. The letters are also blue, and they are surrounded by a swirling pattern. The logo is simple and recognizable, and it is associated with a well-known company.

Diagnostic Ultrasound Indications for Use Form

GE Voluson E Series with RM6C Transducer

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

Mode of Operation
Clinical Application
Anatomy/Region of InterestBMPW
DopplerCW
DopplerColor
DopplerColor M
DopplerPower
DopplerCombined
Modes*Harmonic
ImagingCoded
PulseOther
[Notes]
Ophthalmic
Fetal / Obstetrics[7]PPPPPPPPP[ 5,6]
Abdominal[1]PPPPPPPPP[ 5,6]
PediatricPPPPPPPPP[ 5,6]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletal ConventionalPPPPPPPPP[ 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, Urology

[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)

20

Image /page/20/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized script, enclosed within a circular frame. The logo is colored in blue, with the letters and the frame having the same shade of blue.

Diagnostic Ultrasound Indications for Use Form

GE Voluson E Series with 3Sp-D Transducer

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

Mode of Operation
Clinical Application
Anatomy/Region of InterestBMPW
DopplerCW
DopplerColor
DopplerColor M
DopplerPower
DopplerCombined
Modes*Harmonic
ImagingCoded
PulseOther
[Notes]
Ophthalmic
Fetal / Obstetrics[7]PPPPPPPPPP
Abdominal[1]PPPPPPPPPP
PediatricPPPPPPPPPP
Small Organ[2]
Neonatal Cephalic
Adult CephalicPPPPPPPPPP
Cardiac[3]PPPPPPPPPP
Peripheral Vascular
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

[3] Cardiac is adult and Pediatric

[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)

21

Image /page/21/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized script inside. The letters are also blue, and they are surrounded by a swirling pattern. The logo is simple and recognizable, and it is associated with a well-known company.

Diagnostic Ultrasound Indications for Use Form

GE Voluson E Series with C4-8-D Transducer

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

Mode of Operation
Clinical ApplicationBMPWCWColorColor MPowerCombinedHarmonicCodedOther
Anatomy/Region of InterestDopplerDopplerDopplerDopplerDopplerModesImagingPulse[Notes)
Ophthalmic
Fetal / Obstetrics[7]PPPPPPPDPP[6]
Abdominal[1]PPPPPPPDPP[6]
PediatricPPPPPPPPPP[6]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral VascularPPPPDPPDPP[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

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

[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

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

22

Image /page/22/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 circular frame. The logo is colored in a shade of blue, and the background is white.

Diagnostic Ultrasound Indications for Use Form

GE Voluson E Series with RAB6-D Transducer

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

Mode of Operation
Clinical ApplicationBMPWCWColorColor MPowerCombinedHarmonicCodedOther
Anatomy/Region of InterestDopplerDopplerDopplerDopplerDopplerModes*ImagingPulse[Notes]
Ophthalmic
Fetal / Obstetrics[7]PPPPPPPPPP[5,6]
Abdominal[1]PPPPPPPPPP[5,6]
PediatricPPPPPPPPPP[5,6]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletal ConventionalPPPPPPPPPP[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, Urology

[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)

23

Image /page/23/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 circular frame. The logo is colored in a shade of blue, and the background is white.

Diagnostic Ultrasound Indications for Use Form

GE Voluson E Series with eM6C Transducer

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

Mode of Operation
Clinical Application
Anatomy/Region of InterestBMPW
DopplerCW
DopplerColor#
DopplerColor M
DopplerPower
DopplerCombined*
ModesHarmonic
ImagingCoded
PulseOther
[Notes]
Ophthalmic
Fetal / Obstetrics[7]PPPPPPPPP[ 5,6]
Abdominal[1]PPPPPPPPP[ 5,6]
PediatricPPPPPPPPP[ 5,6]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletal ConventionalPPPPPPPPP[ 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, Urology

[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.

[*] 4D color Doppler (only with eM6C probe)

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

24

Image /page/24/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 circular frame. The logo is colored in a shade of blue, and the background is white.

Diagnostic Ultrasound Indications for Use Form

GE Voluson E Series with S4-10-D Transducer

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

Mode of Operation
Clinical Application
Anatomy/Region of InterestBMPW DopplerCW DopplerColor DopplerColor M DopplerPower DopplerCombined Modes*Harmonic ImagingCoded PulseOther [Notes]
Ophthalmic
Fetal / Obstetrics[7]PPPPPPPPPP
Abdominal[1]PPPPPPPPPP
PediatricPPPPPPPPPP
Small Organ[2]PPPPPPPPPPP
Neonatal CephalicPPPPPPPPPPP
Adult Cephalic
Cardiac[3]PPPPPPPPPPP
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal[8]
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA;

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

[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)

25

510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

Date: September 2, 2014

GE Healthcare [GE Healthcare Austria GmbH & Co OG] Submitter: Tiefenbach 15 Zipf, Austria 4871

  • Primary Contact Person: Tracey Ortiz Regulatory Affairs Director GE Healthcare T:(414)721-6120 F:(414)918-8275

| Secondary Contact Person: | Roland Kuntscher
Regulatory Affairs Specialist
GE Healthcare Austria GmbH & Co OG
T:(+43)7682-3800-660
F:(+43)7682 3800-47 |

-------------------------------------------------------------------------------------------------------------------------------------------------------------------
  • Trade Name: Voluson E Series Ultrasound Systems Device:
    • Models: Voluson E6 / Voluson E8 / Voluson E10

Common/Usual Name: Ultrasound system

Classification Names: Class II

Ultrasonic Pulsed Doppler Imaging System, 21CFR 892.1550 90-IYN Product Code: Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX

  • K132913 Voluson E Series E6/E8/E8Expert/E8Expert LE/E10 Predicate Device(s): Diagnostic Ultrasound System
  • The systems are full-featured Track 3 ultrasound systems, Device Description: primarily for general radiology use and specialized for OB/GYN with particular features for realtime 3D/4D acquisition. They consist of a mobile console with keyboard control panel; color LCD/TFT touch panel, color video display and optional image storage and printing devices. They provide high performance ultrasound imaging and analysis and have comprehensive networking and DICOM capability. They utilize a variety of linear, curved linear, matrix phased array transducers including mechanical and electronic scanning transducers, which provide highly accurate realtime three dimensional imaging supporting all standard acquisition modes.
    • The device is a general purpose ultrasound system. Specific Intended Use: clinical applications remain the same as previously cleared:

26

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 (including GYN); Transrectal

The Voluson E Series (Voluson E6 / Voluson E8 / Voluson E10) Technology: employs the same fundamental scientific technology as its predicate devices.

Comparison to Predicates Determination of

Substantial Equivalence: The Voluson E Series (Voluson E6 / Voluson E8 / Voluson E10) is substantially equivalent to the predicate devices with regards to intended use, imaging capabilities, technologicial characteristics and safety and effectiveness.

  • The systems are all intended for diagnostic ultrasound imaging and fluid flow analysis.
  • The Voluson E Series and predicate Voluson E Series ● systems have the same clinical intended use.
  • . The Voluson E Series and predicate Voluson E Series systems have the same imaging modes.
  • The Voluson E Series and predicate Voluson E Series ● systems transducers are identical except for the removal of three old transducers; no change to the indications for use.
  • . 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 E Series and predicate Voluson E Series ● systems have similar capability in terms of performing measurements, capturing digital images, reviewing and reporting studies.
  • . The Voluson E Series and predicate systems have been designed in compliance with approved electrical and physical safety standards.
  • . The Voluson E Series adds a SIM card to the system to allow users to send images and text via MMS_SMS wirelessly.
  • The Volusion E Series is adding a Fetal Cardio preset to more transducers than was cleared with the predicate.
  • . Labeling and claims are being expanded due to the hardware and software capabilites that can be achieved

27

versus the predicate.

  • . The Voluson E Series adds a GYN measurement tool created by IOTA Group called IOTA LR2 model

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. The Voluson E Series and its applications comply with voluntary standards:

    1. AAMI/ANSI ES60601-1, Medical Electrical Equipment – Part 1: General Requirements for Safety
    1. IEC60601-1-2, Medical Electrical Equipment -Part 1-2:General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility Requirements and Tests
    1. IEC60601-2-37, Medical Electrical Equipment -Part 2-37:Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment
    1. NEMA UD 3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
    1. ISO10993-1, Biological Evaluation of Medical Devices- Part 1: Evaluation and Testing
    1. NEMA UD 2, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
    1. ISO14971. Application of risk management to medical devices
    1. 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)
  • Performance testing (Verification) ●
  • Safety testing (Verification) ●