Voluson E6, Voluson E8, Voluson E10

• K Number: K172342
• Device Name: Voluson E6, Voluson E8, Voluson E10
• Manufacturer: GE Healthcare
• Date Cleared: 2017-09-29 ( 58 days)
• Product Code: IYN , ITX , IYO
• Regulation Number: 892.1550
• Type: Traditional
• Panel: Radiology
• Reference & Predicate Devices: K152309 , K162269
• Predicate For: K181985 , K182679

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); Pediatic; 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 real-time 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 real-time three-dimensional imaging supporting all standard acquisition modes.

AI/ML Overview

This is a 510(k) premarket notification for the GE Healthcare Voluson E6, Voluson E8, and Voluson E10 ultrasound systems. The document states that clinical studies were not required to support substantial equivalence. Therefore, there is no information about specific acceptance criteria related to a study proving device performance, sample sizes for test or training sets, data provenance, expert ground truth establishment, adjudication methods, or MRMC comparative effectiveness studies.

The document focuses on demonstrating substantial equivalence to predicate devices (K162269 Voluson E6_E8_E10 Diagnostic Ultrasound System and K150087 Vivid E80/E90/E95 Diagnostic Ultrasound System) through technological characteristics, intended use, imaging capabilities, safety, and compliance with recognized standards.

Table of Acceptance Criteria and Reported Device Performance:

Since no clinical studies were performed, there are no specific performance metrics reported for the device against acceptance criteria in the traditional sense of a clinical trial. The "acceptance criteria" here are implicitly met by demonstrating substantial equivalence to predicate devices and compliance with safety and performance standards.

Acceptance Criterion Type	Description from Document	Reported Device Performance
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.	The proposed Voluson E Series and predicate Voluson E Series systems have the same clinical intended use. The proposed Voluson E Series adds one new transducer M5Sc-D to the system, but its applications are within the indications for use of the predicate system. No change to system indications for use.
Technological Characteristics	The Voluson E Series (Voluson E6 / Voluson E8 / Voluson E10) employs the same fundamental scientific technology as its predicate devices.	The proposed Voluson E Series and predicate Voluson E Series systems have the same imaging modes and equivalent transducers. The proposed Voluson E Series adds an improved version of existing software feature IOTA LR2 model called IOTA Simple Rules, a Post processing analysis tool from TomTec called Fetal Heart Analysis, a 3D Analysis feature of the endometrial cavity called SonoMetrium, and a Fetal Cardio preset to the new M5Sc-D transducer (already implemented and cleared with other probes).
Safety	Systems are manufactured with materials evaluated and found to be safe; acoustic power levels are below FDA limits; designed in compliance with approved electrical and physical safety standards.	Complies with voluntary standards: AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, NEMA UD 3, ISO10993-1, NEMA UD 2, ISO14971. Transducer materials and other patient contact materials are biocompatible.
Performance	Similar capability in terms of performing measurements, capturing digital images, reviewing and reporting studies. Systems undergo risk analysis, requirements reviews, design reviews, unit testing, integration testing, performance testing, safety testing, and final acceptance testing.	The system has similar capabilities to the predicate with added software features for improved analysis (IOTA Simple Rules, Fetal Heart Analysis, SonoMetrium).

Specific Information Regarding Studies:

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

   • No clinical test set was used, as clinical studies were not required for this 510(k) submission. Non-clinical tests were performed to ensure compliance with standards.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

   • Not applicable, as no clinical test set requiring expert ground truth was utilized.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable due to the absence of a clinical test set.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No MRMC comparative effectiveness study was conducted or reported. The submission focuses on substantial equivalence of the ultrasound system itself, not on specific AI assistance features that would require such a study for performance evaluation. While new software features like "IOTA Simple Rules," "Fetal Heart Analysis," and "SonoMetrium" are mentioned, their specific performance metrics requiring MRMC studies are not detailed or were not deemed necessary for this 510(k) due to claimed substantial equivalence.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Not applicable, as the device is a diagnostic ultrasound system, not a standalone algorithm. The mentioned software features are integrated into the system.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not applicable, as no clinical studies with ground truth were conducted. Compliance with safety and performance standards was demonstrated through non-clinical testing.

7. The sample size for the training set:

   • Not applicable, as no clinical studies were conducted, and therefore no training set was explicitly mentioned. The development of software features would involve internal datasets, but details are not provided in this regulatory document.

8. How the ground truth for the training set was established:

   • Not applicable, for the reasons stated above.

Summary

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Public Health Service

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

September 29, 2017

GE Healthcare % Mr. Bryan Behn Regulatory Affairs Director 9900 Innovation Drive, Milwaukee County Research Park WAUWATOSA WI 53226

Re: K172342

Trade/Device Name: Voluson E6, Voluson E8, Voluson E10 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: August 17, 2017 Received: August 18, 2017

Dear Mr. Behn:

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

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-

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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 (DICE) at its toll-free number [phone] or [phone] or at its Internet address

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

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

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely,

Michael D. O'HaraFor

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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Indications for Use

510(k) Number (if known) K172342

Device Name

Voluson E10, Voluson E8 and Voluson E6

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); Pediatic; 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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. Combinations identified as "E" represents those previously cleared with another GE Ultrasound system and added via Appendix E of the FDA Ultrasound Guidance to this 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 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 Interest	B	M	PWDoppler	CWDoppler	Color#Doppler	Color MDoppler	PowerDoppler	CombinedModes*	HarmonicImaging	CodedPulse	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
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	[ 5,6,9]
Transvaginal[10]	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

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

[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)

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Diagnostic Ultrasound Indications for Use Form

Voluson E6 / Voluson E8 / Voluson E10 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 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]
Abdominal[1]	P	P	P	P	P	P	P	P	P	P	[ 5,6]
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletal Conventional	P	P	P	P	P	P	P	P	P	P	[ 5,6]
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

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

[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

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Image /page/6/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 frame has a decorative, swirling pattern around the letters. The logo is colored in a shade of blue.

Diagnostic Ultrasound Indications for Use Form

Voluson E6 / Voluson E8 / Voluson E10 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 Interest	B	M	PW Doppler	CW Doppler	Color Doppler	Color M Doppler	Power Doppler	Combined Modes*	Harmonic Imaging	Coded Pulse	Other [Notes)
Ophthalmic
Fetal / Obstetrics[7]	P	P	P		P	P	P	P	P	P	[ 5,6,9]
Abdominal[1]
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal[8]	P	P	P		P	P	P	P	P	P	[ 5,6,9]
Transvaginal [10]	P	P	P		P	P	P	P	P	P	[ 5,6,9]
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

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

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

[6] Includes imaging of guidance of biopsy (3D/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 Voluson E6 / Voluson E8 / Voluson E10 with 4C-D Transducer

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

Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes*	HarmonicImaging	CodedPulse	Other[Notes]
Ophthalmic
Fetal / Obstetrics[7]	P	P	P	P	P	P	P	P	P	P	[6]
Abdominal[1]	P	P	P	P	P	P	P	P	P	P	[6]
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular	P	P	P	P	P	P	P	P	P	P	[6]
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

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

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

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

[7] Includes infertility monitoring of follicle development

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

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Diagnostic Ultrasound Indications for Use Form Voluson E6 / Voluson E8 / Voluson E10 with IC5-9-D Transducer

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

	Mode of Operation
Clinical ApplicationAnatomy/Region of 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	[ 6,9]
Abdominal[1]
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal[8]	P	P	P		P	P	P	P	P	P	[ 6,9]
Transvaginal[10]	P	P	P		P	P	P	P	P	P	[ 6,9]
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

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

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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Image /page/9/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 frame has a decorative, swirling pattern around the letters. The logo is colored in a shade of blue.

Diagnostic Ultrasound Indications for Use Form

Voluson E6 / Voluson E8 / Voluson E10 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 Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes*	HarmonicImaging	CodedPulse	Other[Notes]
Ophthalmic
Fetal / Obstetrics[7]
Abdominal[1]
Pediatric	P	P	P		P	P	P	P	P	P	[ 5,6]
Small Organ[2]	P	P	P		P	P	P	P	P	P	[ 5,6]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular	P	P	P		P	P	P	P	P	P	[ 5,6]
Musculo-skeletal Conventional	P	P	P		P	P	P	P	P	P	[ 5,6]
Musculo-skeletal Superficial	P	P	P		P	P	P	P	P	P	[ 5,6]
Other
Exam Type, Means of Access
Transesophageal
Transrectal[8]
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

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

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

[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

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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" in a stylized script, enclosed within a circular frame. The frame has a decorative, swirling pattern around the letters. The logo is colored in a shade of blue.

Diagnostic Ultrasound Indications for Use Form

Voluson E6 / Voluson E8 / Voluson E10 with RIC6-12-D Transducer

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

	Mode of Operation
Clinical Application	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes*	HarmonicImaging	CodedPulse	Other[Notes]
Anatomy/Region of Interest
Ophthalmic
Fetal / Obstetrics[7]	P	P	P		P	P	P	P	P	P	[5,6]
Abdominal[1]
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal[8]	P	P	P		P	P	P	P	P	P	[5,6]
Transvaginal[10]	P	P	P		P	P	P	P	P	P	[5,6]
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

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

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

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

[7] Includes infertility monitoring of follicle development

[8] Includes urology/prostate

[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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Image /page/11/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 frame has a decorative, swirling pattern around the letters. The logo is colored in a shade of blue.

Diagnostic Ultrasound Indications for Use Form

Voluson E6 / Voluson E8 / Voluson E10 with 9L-D Transducer

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

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes*	HarmonicImaging	CodedPulse	Other[Notes]
Ophthalmic
Fetal / Obstetrics[7]	P	P	P	P	P	P	P	P	P	P	[6]
Abdominal[1]
Pediatric	P	P	P	P	P	P	P	P	P	P	[6]
Small Organ[2]	P	P	P	P	P	P	P	P	P	P	[6]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular	P	P	P	P	P	P	P	P	P	P	[6]
Musculo-skeletal Conventional	P	P	P	P	P	P	P	P	P	P	[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)

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Image /page/12/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 frame has decorative swirls or flourishes around the letters. The logo is presented in a blue color.

Diagnostic Ultrasound Indications for Use Form Voluson E6 / Voluson E8 / Voluson E10 with 11L-D Transducer

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

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes*	HarmonicImaging	CodedPulse	Other[Notes]
Ophthalmic
Fetal / Obstetrics[7]
Abdominal[1]
Pediatric	P	P	P		P	P	P	P	P	P	[6,9]
Small Organ[2]	P	P	P		P	P	P	P	P	P	[6,9]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular	P	P	P		P	P	P	P	P	P	[6,9]
Musculo-skeletal Conventional	P	P	P		P	P	P	P	P	P	[6,9]
Musculo-skeletal Superficial	P	P	P		P	P	P	P	P	P	[6,9]
Other
Exam Type, Means of Access
Transesophageal
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)

[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)

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

Image /page/13/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 frame has decorative swirls or flourishes around the letters. The logo is presented in a blue color.

Diagnostic Ultrasound Indications for Use Form Voluson E6 / Voluson E8 / Voluson E10 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	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes*	HarmonicImaging	CodedPulse	Other[Notes]
Anatomy/Region of Interest
Ophthalmic
Fetal / Obstetrics[7]	P	P	P	P	P	P	P	P	P	P	[6]
Abdominal[1]	P	P	P	P	P	P	P	P	P	P	[6]
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular	P	P	P	P	P	P	P	P	P	P	[6]
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

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

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

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

[7] Includes infertility monitoring of follicle development

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

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

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

Image /page/14/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 frame has decorative swirls or flourishes around the letters. The logo is presented in a blue color.

Diagnostic Ultrasound Indications for Use Form Voluson E6 / Voluson E8 / Voluson E10 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	B	M	PW	CW	Color	Color M	Power	Combined	Harmonic	Coded	Other
Anatomy/Region of Interest			Doppler	Doppler	Doppler	Doppler	Doppler	Modes*	Imaging	Pulse	[Notes]
Ophthalmic
Fetal / Obstetrics[7]
Abdominal[1]
Pediatric	P	P	P	P	P	P	P	P	P	P	[6,9]
Small Organ[2]	P	P	P	P	P	P	P	P	P	P	[ 6,9]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular	P	P	P	P	P	P	P	P	P	P	[6,9]
Musculo-skeletal Conventional	P	P	P	P	P	P	P	P	P	P	[ 6,9]
Musculo-skeletal Superficial	P	P	P	P	P	P	P	P	P	P	[ 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

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

[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)

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

Image /page/15/Picture/0 description: The image shows the General Electric (GE) logo. The logo is a blue circle with the letters "GE" in a stylized script inside. There are decorative swirls around the letters and the outer edge of the circle. The logo is simple and recognizable, representing the company's brand.

Diagnostic Ultrasound Indications for Use Form Voluson E6 / Voluson E8 / Voluson E10 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 Interest	B	M	PW Doppler	CW Doppler	Color Doppler	Color M Doppler	Power Doppler	Combined Modes*	Harmonic Imaging	Coded Pulse	Other [Notes]
Ophthalmic
Fetal / Obstetrics[7]	P	P	P		P	P	P	P	P	P	[ 5,6]
Abdominal[1]	P	P	P		P	P	P	P	P	P	[ 5,6]
Pediatric	P	P	P		P	P	P	P	P	P	[ 5,6]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletal Conventional	P	P	P		P	P	P	P	P	P	[ 5,6]
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal
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)

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

Image /page/16/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a blue circle. The letters are stylized and connected, giving the logo a distinctive and recognizable appearance.

Diagnostic Ultrasound Indications for Use Form Voluson E6 / Voluson E8 / Voluson E10 with 3Sp-D Transducer

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

Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes*	HarmonicImaging	CodedPulse	Other[Notes]
Mode of Operation
Ophthalmic
Fetal / Obstetrics[7]	P	P	P	P	P	P	P	P	P	P
Abdominal[1]	P	P	P	P	P	P	P	P	P	P
Pediatric	P	P	P	P	P	P	P	P	P	P
Small Organ[2]
Neonatal Cephalic
Adult Cephalic	P	P	P	P	P	P	P	P	P	P
Cardiac[3]	P	P	P	P	P	P	P	P	P	P
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)

{17}------------------------------------------------

Image /page/17/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 frame has a decorative, swirling pattern around the letters. The logo is colored in a shade of blue.

Diagnostic Ultrasound Indications for Use Form

Voluson E6 / Voluson E8 / Voluson E10 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 Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes*	HarmonicImaging	CodedPulse	Other[Notes]
Ophthalmic
Fetal / Obstetrics[7]	P	P	P	P	P	P	P	P	P	P	[6]
Abdominal[1]	P	P	P	P	P	P	P	P	P	P	[6]
Pediatric	P	P	P	P	P	P	P	P	P	P	[6]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular	P	P	P	P	P	P	P	P	P	P	[6]
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

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

[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 General Electric (GE) logo. The logo consists of the letters "GE" in a stylized script, enclosed within a circular frame. The frame has a decorative, swirling pattern around the letters. The logo is colored in a shade of blue.

Diagnostic Ultrasound Indications for Use Form

Voluson E6 / Voluson E8 / Voluson E10 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 Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes*	HarmonicImaging	CodedPulse	Other[Notes]
Ophthalmic
Fetal / Obstetrics[7]	P	P	P	P	P	P	P	P	P	P	[ 5,6]
Abdominal[1]	P	P	P	P	P	P	P	P	P	P	[ 5,6]
Pediatric	P	P	P	P	P	P	P	P	P	P	[ 5,6]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletal Conventional	P	P	P	P	P	P	P	P	P	P	[ 5,6]
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal
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:

[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)

{19}------------------------------------------------

Image /page/19/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 letters and the frame are both blue, set against a white background.

Diagnostic Ultrasound Indications for Use Form

Voluson E6 / Voluson E8 / 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 Interest	B	M	PWDoppler	CWDoppler	Color#Doppler	Color MDoppler	PowerDoppler	CombinedModes *	HarmonicImaging	CodedPulse	Other[Notes]
Ophthalmic
Fetal / Obstetrics[7]	P	P	P		P	P	P	P	P	P	[ 5,6]
Abdominal[1]	P	P	P		P	P	P	P	P	P	[ 5,6]
Pediatric	P	P	P		P	P	P	P	P	P	[ 5,6]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletal Conventional	P	P	P		P	P	P	P	P	P	[ 5,6]
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal
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:

[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, eM6C G2 probe)

(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 frame has a decorative, swirling pattern around the letters. The logo is colored in a shade of blue.

Diagnostic Ultrasound Indications for Use Form

Voluson E6 / Voluson E8 / Voluson E10 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 Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes*	HarmonicImaging	CodedPulse	Other[Notes]
Ophthalmic
Fetal / Obstetrics[7]	P	P	P	P	P	P	P	P	P	P
Abdominal[1]	P	P	P	P	P	P	P	P	P	P
Pediatric	P	P	P	P	P	P	P	P	P	P
Small Organ[2]	P	P	P	P	P	P	P	P	P	P
Neonatal Cephalic	P	P	P	P	P	P	P	P	P	P
Adult Cephalic
Cardiac[3]	P	P	P	P	P	P	P	P	P	P
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)

{21}------------------------------------------------

Image /page/21/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' written in a stylized, cursive font, enclosed within a circular frame. The color of the letters and the frame is a light blue.

Diagnostic Ultrasound Indications for Use Form Voluson E6 / Voluson E8 / Voluson E10 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 Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes*	HarmonicImaging	CodedPulse	Other[Notes]
Ophthalmic
Fetal / Obstetrics[7]	P	P	P		P	P	P	P	P	P	[6,9]
Abdominal[1]
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal[8]	P	P	P		P	P	P	P	P	P	[6,9]
Transvaginal[10]	P	P	P		P	P	P	P	P	P	[6,9]
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

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

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

(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 script, enclosed within a circular frame. The frame has a decorative, swirling pattern around the letters. The logo is colored in a shade of blue.

Diagnostic Ultrasound Indications for Use Form

Voluson E6 / Voluson E8 / Voluson E10 with eM6C G2 Transducer

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

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PW Doppler	CW Doppler	Color# Doppler	Color M Doppler	Power Doppler	Combined Modes*	Harmonic Imaging	Coded Pulse	Other [Notes]
Ophthalmic
Fetal / Obstetrics[7]	P	P	P		P	P	P	P	P	P	[ 5,6]
Abdominal[1]	P	P	P		P	P	P	P	P	P	[ 5,6]
Pediatric	P	P	P		P	P	P	P	P	P	[ 5,6]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletal Conventional	P	P	P		P	P	P	P	P	P	[ 5,6]
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal
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:

[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, eM6C G2 probe)

(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 script, enclosed within a circular frame. The frame has a decorative, swirling pattern around the letters. The logo is colored in a shade of blue.

Diagnostic Ultrasound Indications for Use Form

Voluson E6 / Voluson E8 / Voluson E10 with C2-9-D Transducer

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

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes*	HarmonicImaging	CodedPulse	Other[Notes]
Ophthalmic
Fetal / Obstetrics[7]	P	P	P	P	P	P	P	P	P	P	[6]
Abdominal[1]	P	P	P	P	P	P	P	P	P	P	[6]
Pediatric	P	P	P	P	P	P	P	P	P	P	[6]
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
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA; E = added under Appendix E (cleared on LOGIQ E9 K152309)

[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)

{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 script, enclosed within a circular frame. The frame has a decorative, swirling pattern around the letters. The logo is colored in a shade of blue.

Diagnostic Ultrasound Indications for Use Form

Voluson E6 / Voluson E8 / Voluson E10 with C1-6-D Transducer

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

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PW Doppler	CW Doppler	Color Doppler	Color M Doppler	Power Doppler	Combined Modes* Harmonic	Harmonic Imaging	Coded Pulse	Other [Notes]
Ophthalmic
Fetal / Obstetrics[7]	P	P	P	P	P	P	P	P	P	P	[6]
Abdominal[1]	P	P	P	P	P	P	P	P	P	P	[6]
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
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA; E = added under Appendix E (cleared on LOGIQ E9 K152309)

[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)

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

Image /page/25/Picture/0 description: The image shows the General Electric (GE) logo. The logo is a blue circle with the letters "GE" in a stylized script inside. There are decorative swirls around the letters and the outer edge of the circle. The logo is simple and recognizable, representing the company's brand.

Diagnostic Ultrasound Indications for Use Form

Voluson E Series with IC4-10-D Transducer

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

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes*	HarmonicImaging	CodedPulse	Other[Notes]
Ophthalmic
Fetal / Obstetrics[7]	P	P	P		P	P	P	P	P	P	[ 6,9]
Abdominal[1]
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal[8]	P	P	P		P	P	P	P	P	P	[ 6,9]
Transvaginal[10]	P	P	P		P	P	P	P	P	P	[ 6,9]
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

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

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

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

{26}------------------------------------------------

Image /page/26/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined within a blue circle. The circle has decorative swirls around the perimeter.

Diagnostic Ultrasound Indications for Use Form

Voluson E6 / Voluson E8 / Voluson E10 with M5Sc-D Transducer

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

Clinical ApplicationAnatomy/Region of Interest	Mode of Operation											Other[Notes]
	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes*	HarmonicImaging	CodedPulse
Ophthalmic
Fetal / Obstetrics[7]	E	E	E	E	E	E	E	E	E	E	[6]
Abdominal[1]
Pediatric	E	E	E	E	E	E	E	E	E	E	[6]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic	E	E	E	E	E	E	E	E	E	E	[6]
Cardiac[3]	E	E	E	E	E	E	E	E	E	E	[6]
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; Previously Cleared K150087

Notes:

[3] Cardiac is adult and Pediatric

[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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510(k) Summary

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

Date:	August 1, 2017
Submitter:	GE Healthcare [GE Healthcare Austria GmbH & Co OG]Tiefenbach 15Zipf, Austria 4871
Primary ContactPerson:	Bryan BehnRegulatory Affairs DirectorGE HealthcareT:[phone]F:[phone]
Secondary ContactPerson:	Roland KuntscherRegulatory Affairs SpecialistGE Healthcare Austria GmbH & Co OGT:([phone]F:([phone]
TradeDevice:	Voluson E6, Voluson E8, Voluson E10
Name:	Models: Voluson E6 / Voluson E8 / Voluson E10
Common/UsualName:	Ultrasound system
Classification Names:	Class II
Product Code:	Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550, 90-IYNUltrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYODiagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX
Primary PredicateDevice(s):	K162269 Voluson E6_E8_E10 Diagnostic Ultrasound System
SecondaryPredicate(s):	K150087 Vivid E80/E90/E95 Diagnostic Ultrasound System
Device Description:	The systems are full-featured Track 3 ultrasound systems, primarily forgeneral radiology use and specialized for OB/GYN with particularfeatures for real-time 3D/4D acquisition. They consist of a mobileconsole 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 andhave comprehensive networking and DICOM capability. They utilize a

variety of linear, curved linear, matrix phased array transducers

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including mechanical and electronic scanning transducers. which provide highly accurate real-time three-dimensional imaging supporting all standard acquisition modes.

The device is a general-purpose ultrasound system. Specific clinical Intended Use: applications remain the same as previously cleared: Fetal/OB: Abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatric; Small Organ (breast, testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Musculoskeletal Conventional and Superficial; Peripheral Vascular: Transvaginal (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.

• 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.
• The proposed Voluson E Series and predicate Voluson E Series systems have the same imaging modes.
• The proposed Voluson E Series and predicate Voluson E Series systems transducers are equivalent. The proposed Voluson E Series adds one new transducer M5Sc-D to the system. Applications for this probe is within the indications for use of the predicate system.
• There is no change to the system 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 proposed Voluson E Series and predicate Voluson E Series ● systems have similar capability in terms of performing

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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 adds an improved version of ● existing software feature IOTA LR2 model called IOTA Simple Rules
• The proposed Voluson E Series adds a Post processing analysis ● tool from TomTec called Fetal Heart Analysis
• The proposed Voluson E Series adds an 3D Analysis feature of ● the endometrial cavity called SonoMetrium
• o The proposed Voluson E Series is adding a Fetal Cardio preset to one new M5Sc-D transducer. Fetal Cardio setting is already implemented and cleared with probes eM6C, eM6CG2, RM6C, C1-5-D, C4-8-D, C1-6-D and C2-9-D (K162269).

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:

• . AAMI/ANSI ES60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 2005/(R)2012 And A1:2012
• IEC60601-1-2 Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility Requirements and Tests, 2007
• IEC60601-2-37, Medical Electrical Equipment - Part 2-37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment, 2007
• NEMA UD 3, Standard for Real Time Display of Thermal and ● Mechanical Acoustic Output Indices on Diagnostic Ultrasound

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Equipment:2004

• ISO10993-1, Biological Evaluation of Medical Devices- Part 1: ● Evaluation and Testing- Third Edition, 2009
• NEMA UD 2, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment:2004
• o ISO14971, Application of risk management to medical devices: Second edition 2007
• o NEMA PS 3.1 - 3.20 (2011), Digital Imaging and Communications in Medicine (DICOM) Set. (Radiology)

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

• Risk Analysis ●
• Requirements Reviews ●
• Design Reviews ●
• Testing on unit level (Module verification) ●
• Integration testing (System verification) ●
• 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.

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

Regulation Number and Section

§ 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.