LogoFDA 510(k) Search
K Number
K152567
Device Name
Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound System
Manufacturer
GE Healthcare
Date Cleared
2015-11-06

(58 days)

Product Code
IYN,ITX,IYO
Regulation Number
892.1550
Type
Special
Panel
Radiology
Reference & Predicate Devices
N/A
Predicate For
K160162,K160184,K162267,K162269
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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.

AI/ML Overview

The provided FDA 510(k) summary for the GE Healthcare Voluson E6, Voluson E8, and Voluson E10 Diagnostic Ultrasound Systems does not contain details about acceptance criteria or a specific study that proves the device meets acceptance criteria in the context of an AI/algorithm-driven device with performance metrics like sensitivity, specificity, etc.

This submission is for a general-purpose ultrasound system, and the "study" described is a non-clinical evaluation to ensure the device's safety and effectiveness compared to a predicate device. The information provided heavily emphasizes substantial equivalence to a previously cleared ultrasound system (K142472).

Therefore, I cannot extract information to fill in most of the requested fields related to acceptance criteria and device performance based on the input text. However, I can provide what is present, highlighting the absence of AI-specific performance criteria.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not provide a table of performance acceptance criteria (e.g., sensitivity, specificity, accuracy) for an AI/algorithm feature, nor does it report such performance. The "acceptance criteria" here are framed around compliance with safety standards and equivalence to a predicate device.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable in the context of AI performance studies. The non-clinical tests would have involved various hardware and software validation tests, but not a "test set" of clinical cases for AI performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable for an AI performance study. Ground truth in this context would refer to engineering and safety standards compliance.

4. Adjudication Method for the Test Set

Not applicable for an AI performance study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. The document explicitly states: "The subject of this premarket submission, Voluson E Series (Voluson E6 / Voluson E8 / Voluson E10), did not require clinical studies to support substantial equivalence." This indicates no MRMC study or any clinical study was performed for this 510(k) submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not applicable for a standalone AI performance. The document describes an "improved version of an existing software feature SonoAVC called SonoAVC Antral (Antral follicle count)" which "The algorithm has more sensitivity to detect antral (small) follicles." However, no standalone performance study results or acceptance criteria for this improved sensitivity are provided. The claim is made, but no supporting data in the form of a performance study is included in this summary.

7. The Type of Ground Truth Used

For the general ultrasound system and its components (including the SonoAVC Antral feature), the "ground truth" for demonstrating substantial equivalence primarily relies on:

  • Engineering measurements and tests against established medical device safety standards (e.g., acoustic output, electrical safety).
  • Comparison to the performance and specifications of the predicate device (K142472 Voluson E6_E8_E10 Diagnostic Ultrasound System).
  • The improved SonoAVC Antral feature claims "more sensitivity to detect antral (small) follicles," implying that some form of internal validation was done against either expert assessment or another reliable method to establish "ground truth" for follicle detection. However, details of such validation are not provided in this summary.

8. The Sample Size for the Training Set

Not applicable. This document does not describe the development or training of an AI/ML model for which a training set size would be relevant. While the SonoAVC Antral is an algorithm, details on its development or training data are not present.

9. How the Ground Truth for the Training Set was Established

Not applicable. (See #8)

Summary of what is available from the document regarding "acceptance criteria" and "performance":

The acceptance criteria for this ultrasound system are based on demonstrating substantial equivalence to a predicate device (K142472 Voluson E6_E8_E10 Diagnostic Ultrasound System) regarding:

  • Intended Use: The systems are for diagnostic ultrasound imaging and fluid flow analysis, with specific clinical applications (Fetal/OB, Abdominal, Pediatric, Small Organ, Neonatal/Adult Cephalic, Cardiac, Musculo-skeletal, Peripheral Vascular, Transvaginal, Transrectal) remaining the same as previously cleared.
  • Technological Characteristics: Employing the same fundamental scientific technology and imaging modes as predicate devices.
  • Safety and Effectiveness:
    • Manufactured with materials assessed as safe.
    • Acoustic power levels below FDA limits.
    • Compliance with various safety standards (AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, NEMA UD 3, ISO10993-1, NEMA UD 2, ISO14971, NEMA DICOM).
    • Similar capability in measurements, digital image capture, reviewing, and reporting.
    • Designed in compliance with approved electrical and physical safety standards.
    • Transducers are equivalent to the predicate (with some removals and additions of new transducers (IC9-D and eM6C G2) whose applications are within the predicate's indications for use).
    • Addition of an improved SonoAVC Antral feature ("The algorithm has more sensitivity to detect antral (small) follicles"). No specific quantitative performance metric or acceptance criteria are given for this sensitivity improvement in this document.
    • Addition of a Fetal Cardio preset (already cleared in the predicate).
    • Addition of a card reader/bar code scanner.

Reported Device Performance:

The document primarily reports that the device conforms to applicable medical device safety standards and that its performance and features are substantially equivalent to the predicate device. The only specific performance claim related to an algorithm is that SonoAVC Antral has "more sensitivity to detect antral (small) follicles," but no quantifiable performance metrics, specific acceptance criteria, or a study detailing this improvement are provided in this summary. The non-clinical tests evaluated the device for safety (acoustic output, biocompatibility, cleaning/disinfection, thermal, electrical, electromagnetic, mechanical safety) and confirmed compliance with voluntary standards. No clinical studies were required or performed.

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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, which is a symbol of medicine and health. The caduceus is composed of three human profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.

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

November 6, 2015

GE Healthcare % Ms. Ayesha Pergadia Regulatory Affairs Leader 3114 N. Grandview Blvd. WAUKESHA WI 53188

Re: K152567

Trade/Device Name: Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: October 16, 2015 Received: October 20, 2015

Dear Ms. Pergadia:

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

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.

{1}------------------------------------------------

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.

Michael D'Hara

For

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K152567

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 Use (21 CFR 801 Subpart C)

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement on last page.

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

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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 proposed 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:

Mode of Operation
Clinical ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColor#DopplerColor MDopplerPowerDopplerCombinedModesHarmonicImagingCodedPulseOther[Notes]
Ophthalmic
Fetal / Obstetrics[7]PPPPPPPPPP[5,6,9]
Abdominal[1]PPPPPPPPPP[5,6,9]
PediatricPPPPPPPPPP[5,6,9]
Small Organ[2]PPPPPPPPPP[5,6,9]
Neonatal CephalicPPPPPPPPPP[5]
Adult CephalicPPPPPPPPPP
Cardiac[3]PPPPPPPPPP[5]
Peripheral VascularPPPPPPPPPP[5,6,9]
Musculo-skeletal ConventionalPPPPPPPPPP[5,6,9]
Musculo-skeletal SuperficialPPPPPPPPPP[5,6,9]
Other
Exam Type, Means of Access
Transesophageal
Transrectal[8]PPPPPPPPPP[5,6,9]
Transvaginal[10]PPPPPPPPPP[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

[*] Voluson E10 Only: 4D color Doppler (only with eM6C probe and eM6C G2)

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

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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 ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther[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
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)

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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 ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther[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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GE Voluson E Series with 4C-D Transducer

Mode of Operation
Clinical ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther[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

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

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)

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

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 ApplicationBMPWCWColorColor MPowerCombinedHarmonicCodedOther
Anatomy/Region of InterestDopplerDopplerDopplerDopplerDopplerModesImagingPulse[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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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 ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther[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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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 ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModesHarmonicImagingCodedPulseOther[Notes]
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

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

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GE Voluson E Series with 9L-D Transducer

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

Clinical ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther[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

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

[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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GE Voluson E Series with 11L-D Transducer

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

Clinical ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther[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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GE Voluson E Series with C1-5-D Transducer

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

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

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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GE Voluson E Series with ML6-15-D Transducer

Mode of Operation
Clinical ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther[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

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

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

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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 ApplicationAnatomy/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

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GE Voluson E Series with 3Sp-D Transducer

Mode of Operation
Clinical ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther[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

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

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

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

[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

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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 ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther[Notes]
Ophthalmic
Fetal / Obstetrics[7]PPPPPPPPPP[6]
Abdominal[1]PPPPPPPPPP[6]
PediatricPPPPPPPPPP[6]
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

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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 ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther[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

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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 ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther[Notes]
Ophthalmic
Fetal / Obstetrics[7]PPPPPPPPPP
Abdominal[1]PPPPPPPPPP
PediatricPPPPPPPPPP
Small Organ[2]PPPPPPPPPP
Neonatal CephalicPPPPPPPPPP
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

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GE Voluson E Series with IC9-D Transducer

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

Mode of Operation
Clinical ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther[Notes]
Ophthalmic
Fetal / Obstetrics[7]NNNNNNNNN[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]NNNNNNNNN[6,9]
Transvaginal[10]NNNNNNNNN[6,9]
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

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

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

[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

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GE Voluson E10 with eM6C G2 Transducer

Mode of Operation
Clinical ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColor#DopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther[Notes]
Ophthalmic
Fetal / Obstetrics[7]NNNNNNNNN[5,6]
Abdominal[1]NNNNNNNNN[5,6]
PediatricNNNNNNNNN[5,6]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletal ConventionalNNNNNNNNN[5,6]
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

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

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

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

[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.

[*] Voluson E10 Only: 4D color Doppler (only with eM6C, eM6C G2 probe)

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GE Voluson E10 with eM6C Transducer

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

Mode of Operation
Clinical ApplicationAnatomy/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.

[*] Voluson E10 Only: 4D color Doppler (only with eM6C, eM6C G2 probe)

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510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:
Date:September 4, 2015
Submitter:GE Healthcare [GE Healthcare Austria GmbH & Co OG]Tiefenbach 15Zipf, Austria 4871
Primary Contact Person:Ayesha PergadiaRegulatory Affairs LeaderGE HealthcareT:(314)330-7043F:(414)918-8275
Secondary Contact Person:Roland KuntscherRegulatory Affairs SpecialistGE Healthcare Austria GmbH & Co OGT:(+43)7682-3800-660F:(+43)7682 3800-47
Device:Trade Name: Voluson E Series Ultrasound Systems
Models: Voluson E6/Voluson E8/Voluson E10
Common/Usual Name:Ultrasound system
Classification Names:Product Code:Class IIUltrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-IYN Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560,90-IYO Diagnostic Ultrasound Transducer, 21 CFR 892.1570,90-ITX
Predicate Device(s):K142472 Voluson E6_E8_E10 Diagnostic Ultrasound System
Device Description:The systems are full-featured Track 3 ultrasound systems,primarily for general radiology use and specialized for OB/GYNwith particular features for realtime 3D/4D acquisition. Theyconsist of a mobile console with keyboard control panel; colorLCD/TFT touch panel, color video display and optional imagestorage and printing devices. They provide high performanceultrasound imaging and analysis and have comprehensivenetworking and DICOM capability. They utilize a variety oflinear, curved linear, matrix phased array transducers includingmechanical and electronic scanning transducers, which providehighly accurate realtime three dimensional imaging supporting all

standard acquisition modes.

{25}------------------------------------------------

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

Determination of Comparison to Predicates

Substantial Equivalence:

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

  • o The systems are all intended for diagnostic ultrasound imaging and fluid flow analysis.
  • The proposed Voluson E Series and predicate Voluson E Series systems have the same clinical intended use.
  • o The proposed Voluson E Series and predicate Voluson E Series systems have the same imaging modes.
  • There is no change to the system indications for use. ●
  • o The systems are manufactured with materials which have been evaluated and have been 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 proposed 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 proposed Voluson E Series and predicate systems have been designed in compliance with approved electrical and physical safety standards.
  • The proposed Voluson E Series and predicate Voluson E ● Series system transducers are equivalent. The proposed Voluson E Series removes three transducers (RNA5-9-D,

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P2D, P6D) that were available on the predicate but are no longer being supported.

  • o The proposed Voluson E Series adds two new transducers:
    IC9-D (Compatible with Voluson E6/Voluson E8/Voluson E10)

eM6C G2 (Compatible with Voluson E10)

Applications for these probes are within the indications for use of the predicate system.

  • The proposed Voluson E Series adds and improved version of an existing software feature SonoAVC called SonoAVC Antral (Antral follicle count). The algorithm has more sensitivity to detect antral (small) follicles.
  • . The proposed Voluson E Series is adding a Fetal Cardio preset to the new probe eM6C G2 transducer. The Fetal Cardio setting is already implemented and cleared in K142472.
  • The proposed Voluson E Series is adding a card reader/bar code scanner used to support data entry.

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:

  • o AAMI/ANSI ES60601-1, Medical Electrical Equipment -Part 1: General Requirements for Safety
  • IEC60601-1-2, Medical Electrical Equipment -● Part 1-2:General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility Requirements and Tests
  • IEC60601-2-37, Medical Electrical Equipment o Part 2-

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37:Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment

  • . NEMA UD 3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
  • o ISO10993-1, Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing
  • o NEMA UD 2, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
  • ISO14971, Application of risk management to medical devices
  • 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)
  • Final Acceptance Testing (Validation)

Transducer materials and other patient contact materials are biocompatible.

Summary of Clinical Tests:

The subject of this premarket submission, Voluson E Series (Voluson E6 / Voluson E8 / Voluson E10), did not require clinical studies to support substantial equivalence.

  • Conclusion: GE Healthcare considers the proposed Voluson E Series (Voluson E6 / Voluson E8 / Voluson E10) to be as safe, as effective, and performance is substantially equivalent to the predicate device(s).

§ 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.