VOLUSON E6/E8/E8EXPERT/E10

K113758 · GE Healthcare · IYE · Jan 10, 2012 · Radiology

Device Facts

• Record ID: K113758
• Device Name: VOLUSON E6/E8/E8EXPERT/E10
• Applicant: GE Healthcare
• Product Code: IYE · Radiology
• Decision Date: Jan 10, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Pediatric

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); Musculoskeletal Conventional and Superficial; Peripheral Vascular; Transvaginal; Transrectal; and Intraoperative (abdominal, PV and neurological).

Device Story

Voluson E6/E8/E8Expert/E10 is a mobile diagnostic ultrasound system for general radiology and OB/GYN. It utilizes various linear, curved linear, and matrix phased array transducers (mechanical/electronic scanning) to acquire ultrasound signals. The system processes these inputs to provide 2D, 3D, and 4D real-time imaging, Doppler (PW, CW, Color, Power), and M-mode analysis. Operated by clinicians in clinical settings, the system features a console with keyboard, touch panel, and display. It supports DICOM networking for image storage and printing. Output allows clinicians to visualize anatomy and blood flow, aiding in diagnostic assessments, biopsy guidance, and infertility monitoring. Benefits include high-performance imaging for diverse clinical applications.

Clinical Evidence

No clinical studies were required to support substantial equivalence. The device relies on non-clinical bench testing, including acoustic output, biocompatibility, cleaning/disinfection effectiveness, and thermal, electrical, electromagnetic, and mechanical safety verification.

Technological Characteristics

Mobile ultrasound console with color LCD/TFT touch panel. Supports linear, curved linear, and matrix phased array transducers. Imaging modes: B, M, PW/CW Doppler, Color/Power Doppler, 3D/4D, Harmonic, Coded Pulse. Connectivity: DICOM, networked. Biocompatible patient-contact materials. Software-based signal processing for ultrasound acquisition and analysis.

Indications for Use

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

Regulatory Classification

Identification

A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.

Predicate Devices

• Voluson E6/E8/E8Expert/E10 Diagnostic Ultrasound System (K112213)

Submission Summary (Full Text)

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K113758

JAN 1 0 2012

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510(k) Premarket Notification Submission

#### 510(k) Summary

| | In accordance with 21 CFR 807.92 the following summary of information is provided: |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | December 21, 2011 |
| Submitter: | GE Healthcare [GE Healthcare Austria GmbH & Co OG]<br>Tiefenbach 15<br>Zipf, Austria 4871 |
| Primary Contact Person: | Bryan Behn<br>Regulatory Affairs Manager<br>GE Healthcare<br>T:[phone]<br>F:[phone] |
| Secondary Contact Person: | Roland Kuntscher<br>Regulatory Affairs Specialist<br>GE Healthcare Austria GmbH & Co OG<br>T:(++43)7682-3800-660<br>F:(++43)7682 3800-47 |
| Device: | Voluson E6/E8/E8Expert/E10 Diagnostic Ultrasound System |
| Trade Name: | Voluson E6/E8/E8Expert/E10 |
| Common/Usual Name: | Voluson E6/E8/E8Expert/E10 |
| Classification Names: | Class II |
| Product Code: | Class II<br>Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-IYN<br>Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO<br>Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX |
| Predicate Device(s): | K112213 Voluson E6/E8/E8Expert/E10 Diagnostic Ultrasound<br>System |
| Device Description: | The Voluson E6/E8/E8Expert/E10 system is a full-featured Track 3 ultrasound system, primarily for general radiology use and specialized for OB/GYN with particular features for realtime 3D/4D acquisition. It consists of a mobile console with keyboard control panel; color LCD/TFT touch panel, color video display and optional image storage and printing devices. It provides high performance ultrasound imaging and analysis and has comprehensive networking and DICOM capability. It utilizes 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. |
| Intended Use: | The device is a general purpose ultrasound system. Specific clinical applications remain the same as previously cleared |

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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; Transrectal; and Vascular; Transvaginal; Peripheral Intraoperative (abdominal, PV and neurological).

The Voluson E6/E8/E8Expert/E10 employs the same Technology: fundamental scientific technology as its predicate devices.

Summary of Non-Clinical Tests: Determination of Substantial Equivalence:

The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic, and mechanical safety, and has been found to conform with applicable medical device safety standards. The Voluson E6/E8/E8Expert/E10 and its applications comply with voluntary standards as detailed in Section 9, 11 and 17 of this premarket submission. The following quality assurance measures were applied to the development of the system:

- . Risk Analysis
- Requirements Reviews .
- Design Reviews
- Testing on unit level (Module verification) ●
- Integration testing (System verification) .
- Final Acceptance Testing (Validation) .
- Performance testing (Verification) .
- Safety testing (Verification) ●

Transducer materials and other patient contact materials are biocompatible.

#### Summary of Clinical Tests:

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

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

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Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

JAN 1 0 2012

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

Re: K113758

Trade/Device Name: Voluson E6/E8/E8Expert/E10 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: December 21, 2011 Received: December 21, 2011

Dear Mr. Behn:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). 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.

This determination of substantial equivalence applies to the following transducers intended for use with the DUS 6000 Digital Ultrasonic Imaging System, as described in your premarket notification:

#### Transducer Model Number

### C4-8-D RAB6-D

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. In addition, FDA

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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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

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

If you have any questions regarding the content of this letter, please contact Michael O'Hara at [phone].

Sincerely Yours.

Mary S Pastel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure(s)

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510(k) Number (if known):

Voluson E6/E8/E8Expert/E10 Diagnostic Ultrasound System Device Name:

.. "

Indications for Use:

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

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

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

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary S Patel

(Division Sign-Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) Number K113758

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Image /page/5/Picture/0 description: The image shows a logo with the letters 'GE' intertwined within a circular border. The letters are stylized and connected, creating a unique monogram. The logo is in black and white, with the letters and border appearing in black against a white background. The overall design is simple yet recognizable, representing the General Electric brand.

### Indications for Use Forms

The following forms represent indications with clinical applications and exam types along with the modes of operation for the Voluson E6/E8/E8Expert/E10 system and for all of its probe/mode combinations. There have been no changes to the system level indications for use or modes and no new transducers have been added to the unmodified device. The only change is CW mode has been added to C4-8-D and RAB6-D via Appendix E of the Ultrasound Guidance. This was mistakenly missed in the transducer tables in K112213 and is now being corrected.

(Division Sign-Off)

Division of Radiological De Office of In Vitro Diagnostic

510K K113758

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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" intertwined and enclosed within a circle. The letters are stylized and connected, creating a distinctive and recognizable brand symbol.

#### Diagnostic Ultrasound Indications for Use Form GE Voluson E6/E8/E8Expert/E10 Ultrasound System

| | Mode of Operation | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|------------------|
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[Notes] |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics[7] | P | P | P | P | P | P | P | P | P | P | [5,6,9] |
| Abdominal[1] | P | P | P | P | P | P | P | P | P | P | [5,6,9] |
| Pediatric | P | P | P | P | P | P | P | P | P | P | [5,6,9] |
| Small 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 | P | [5,6,9] |
| Transvaginal | P | P | P | P | P | P | P | P | P | P | [5,6,9] |
| Transuretheral | | | | | | | | | | | |
| Intraoperative | P | P | P | P | P | P | P | P | P | P | |
| Intraoperative Neurological | P | P | P | P | P | P | P | P | P | P | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |

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

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

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

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

[3] Cardiac is Adult and Pediatric.

[5] 3D/4D Imaging Mode.

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

[7] Includes infertility monitoring of follicle development.

[8] Includes urology/prostate.

[9] Elastography imaging- Elasticity

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

[*] 4D color Doppler

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Prescription User (Per 21 CFR 801.109)

y Pastel

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and

510K.

and Safety

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Image /page/7/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circle. The letters and the circle are in black, contrasting with the white background.

# Diagnostic Ultrasound Indications for Use Form GE Voluson E6/E8/E8Expert/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 Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[Notes] |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics[7] | P | P | P | E | P | P | P | P | P | P | [6] |
| Abdominal[1] | P | P | P | E | P | P | P | P | P | P | [6] |
| Pediatric | P | P | P | E | P | P | P | P | P | P | [6] |
| Small Organ[2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac[3] | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | E | 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)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Prescription User (Per 21 CFR 801.109)

Mary S. Patil
(Division Sign-Off)

દાપ્રદ

Division of Radiological Devices valuation and Safety Office of In Vitro D

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Image /page/8/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "G" and "E" intertwined within a circular border. The letters are stylized and appear to be hand-drawn or calligraphic. The logo is black and white.

# Diagnostic Ultrasound Indications for Use Form GE Voluson E6/E8/E8Expert/E10 with RAB6-D Transducer

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

| | Mode of Operation | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|------------------|
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[Notes) |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics[7] | P | P | P | E | P | P | P | P | P | P | [5,6] |
| Abdominal[1] | P | P | P | E | P | P | P | P | P | P | [5,6] |
| Pediatric | P | P | P | E | 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 | E | P | P | P | P | P | P | [5,6] |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |

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

[ i ] 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

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

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Prescription User (Per 21 CFR 801.109)

Mary S Patil

Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

יין יו

K113758