VOLUSON E6/E8/E8EXPERT/E10
Device Facts
| Record ID | K122327 |
|---|---|
| Device Name | VOLUSON E6/E8/E8EXPERT/E10 |
| Applicant | GE Healthcare |
| Product Code | IYN · Radiology |
| Decision Date | Sep 21, 2012 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| 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); Musculo-skeletal Conventional and Superficial; Vascular; Transvaginal; Transrectal: and Peripheral Intraoperative (abdominal, PV and neurological).
Device Story
Voluson E6/E8/E8Expert/E10 is a mobile, full-featured Track 3 diagnostic ultrasound system. It processes acoustic signals from various linear, curved linear, and matrix phased array transducers (mechanical and electronic scanning) to produce real-time 2D, 3D, and 4D images. Used in clinical settings (radiology, OB/GYN) by physicians and sonographers. The system features a console with keyboard, touch panel, and display; it supports comprehensive networking and DICOM. Output includes ultrasound images and analysis data, used by clinicians for diagnostic assessment and biopsy guidance. Benefits include high-performance imaging for fetal, abdominal, cardiac, and vascular monitoring.
Clinical Evidence
No clinical studies were required to support substantial equivalence. The device was evaluated via non-clinical bench testing, including acoustic output measurement, biocompatibility, and compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 2, and NEMA UD 3 standards.
Technological Characteristics
Mobile ultrasound console with keyboard, touch panel, and display. Utilizes linear, curved linear, and matrix phased array transducers (mechanical/electronic). Supports B, M, PW/CW Doppler, Color/Power Doppler, Harmonic Imaging, and 3D/4D modes. Connectivity via DICOM. Biocompatible patient-contact materials. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, and NEMA UD 2/3 standards.
Indications for Use
Indicated for diagnostic ultrasound imaging or fluid flow analysis of the human body, including Fetal/OB, Abdominal, Pediatric, Small Organ, Neonatal/Adult Cephalic, Cardiac, Musculoskeletal, Vascular, Transvaginal, Transrectal, and Intraoperative applications.
Regulatory Classification
Identification
An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Predicate Devices
- Voluson E6/E8/E8Expert/E10 Diagnostic Ultrasound System (K113758)
- LOGIQ S8 Diagnostic Ultrasound System (K111582)
Related Devices
- K113758 — VOLUSON E6/E8/E8EXPERT/E10 · GE Healthcare · Jan 10, 2012
- K132913 — VOLUSON E6 / E8 / E8EXPERT / E8EXPERT LIMITED EDITION / E10 · GE Healthcare · Nov 8, 2013
- K181985 — Voluson E6, Voluson E8, Voluson E10 · GE Healthcare · Nov 15, 2018
- K112213 — VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM · GE Healthcare · Sep 1, 2011
- K142472 — Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound Systems · GE Healthcare · Feb 10, 2015
Submission Summary (Full Text)
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122327
SEP 2 1 2012
Image /page/0/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The letters are enclosed within a circular border that has a textured or patterned design.
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510(k) Premarket Notification Submission
#### 510(k) Summary
く
| | In accordance with 21 CFR 807.92 the following summary of information is provided: |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | July 31, 2012 |
| 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:(414)721-4214<br>F:(414)918-8275 |
| 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: Trade Name: | Voluson E6/E8/E8Expert/E10 Diagnostic Ultrasound System |
| Common/Usual Name: | Voluson E6/E8/E8Expert/E10 |
| Classification Names: | Class II |
| Product Code: | Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-IYN<br>Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO<br>Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX |
| Predicate Device(s): | K113758 Voluson E6/E8/E8Expert/E10 Diagnostic Ultrasound<br>System<br>K111582 LOGIQ S8 Diagnostic Ultrasound System |
| Device Description: | The Voluson E6/E8/E8Expert/E10 system is a full-featured Track<br>3 ultrasound system, primarily for general radiology use and<br>specialized for OB/GYN with particular features for realtime<br>3D/4D acquisition. It consists of a mobile console with keyboard<br>control panel; color LCD/TFT touch panel, color video display<br>and optional image storage and printing devices. It provides high<br>performance ultrasound imaging and analysis and has<br>comprehensive networking and DICOM capability. It utilizes a<br>variety of linear, curved linear, matrix phased array transducers<br>including mechanical and electronic scanning transducers, which<br>provide highly accurate realtime three dimensional imaging<br>supporting all standard acquisition modes. |
| Intended Use: | The device is a general purpose ultrasound system. Specific<br>clinical applications remain the same as previously cleared: |
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Image /page/1/Picture/0 description: The image shows a black and white logo of General Electric (GE). The logo consists of the letters 'G' and 'E' intertwined within a circular border. The design is stylized and recognizable as the brand identity of GE.
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; Vascular; Transvaginal; Transrectal: and Peripheral Intraoperative (abdominal, PV and neurological).
The Voluson E6/E8/E8Expert/E10 employs the same Technology: fundamental scientific technology as its predicate devices.
Determination of Substantial Equivalence:
Summary of Non-Clinical Tests:
ﻬﺎ ﻓﻬ
,
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:
- 1. IEC60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety
- 2. IEC60601-1-2,Medical Electrical Equipment -Part 1-2:General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility Requirements and Tests
- 3. IEC60601-2-37, Medical Electrical Equipment -Part 2-37:Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment
- 4. NEMA UD 3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- 5. ISO10993-1, Biological Evaluation of Medical Devices- Part 1: Evaluation and Testing- Third Edition
- NEMA UD 2, Acoustic Output Measurement Standard 6. for Diagnostic Ultrasound Equipment
- 7. ISO14971. Application of risk management to medical devices
- 8. NEMA, Digital Imaging and Communications in Medicine (DICOM) Set. (Radiology) ·
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Image /page/2/Picture/0 description: The image shows a logo of General Electric (GE). The logo is a circular emblem with the letters 'GE' intertwined in a stylized, cursive font. The letters are surrounded by a decorative, swirling pattern within the circle.
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.
- GE Healthcare considers the Voluson E6/E8/E8 Expert/E10 to be Conclusion: as safe, as effective, and performance is substantially equivalent to the predicate device(s).
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#### DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" surrounding the top and left side of the circle. The text is written in a sans-serif font and is arranged to follow the curve of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
SEP 2 1 2012
Mr. Bryan Behn Regulatory Affairs Manager GE Healthcare 9900 W. Innovation Drive WAUWATOSA WI 53226
Re: K122327
Trade/Device Name: Voluson E6/E8/E8 Expert/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: August 28, 2012 Received: August 29, 2012
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 Voluson E6/E8/E8 Expert/E10 Diagnostic Ultrasound System, as described in your premarket notification:
| | Transducer Model Number | |
|-----------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| RAB2-5-D<br>RAB4-8-D<br>RIC5-9-D<br>RNA5-9-D<br>RRE6-10-D<br>AB2-7-D<br>4C-D<br>IC5-9-D<br>PA6-8-D<br>SP10-16-D | RSP6-16-D<br>RIC6-12-D<br>RAM3-8<br>RSM5-14<br>9L-D<br>3S-D<br>P2D<br>P6D<br>M6C<br>11L-D | C1-5-D<br>ML6-15-D<br>RM6C<br>RRE5-10-D<br>RM14L<br>3Sp-D<br>C4-8-D<br>RAB6-D<br>eM6C<br>S4-10-D |
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If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be If your device is classified (see above) into emiss affecting your device can be found in the subject to such additions. Title 21, Parts 800 to 895. In addition, FDA may publish further
Code of Federal Regulations, Title 21, Parts 800 to Beats Code of I ederal Regaration your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Agt or any Please be advised that FDA's Issualice of a substance requirements of the Act or any
FDA has made a determination that your device complies. You must compley with all FDA has made a determination mat your device compless . You must comply with all the Federal statutes and regulations administered by oner edenar and listing (21 CFR Part 807); abeling (21
Act's requirements, including, but not limited to: registres in the ev Act's requirements, including, but not minical to: requirements as set forth in the quality systems (QS)
CFR Part 801); good manufacturing practice requirements as see forth CFR Part 801); good manufacturing practice requirements as seconduct radiation control provisions
regulation (21 CFR Part 820); and if applicable, the electronic provisions i (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 netification.
In the subscription of the first of any device to a logally market pred This letter will allow you to begin marketing your device to a legally marketed predicate device results
The FDA finding of substantial equivalence of your device to areased The FDA Tinding of Substantal Cquivalence or your device to proceed to market.
in a classification for your device and thus permits your device to proceed to market.
lf you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to If you desire specific advice for your device on our areasones and 15809.htm for the Center for
http://www.fda.gov/AboutFDA/CenterSDffices/CDRHOPfices/crom I 15809.html or r http://www.tda.gov/AboutFDA/CemersOffices/Office of Compliance. Also, please note the regulations Devices and Kadiological Health S (ODNI S) Online the Corner (2) CFF Part 807.97). For questions
entitled, "Misbranding by reference to premarket notifical CCFR Part 803), p entitled, "Misbranding by reference to premaince (1) C CFR Part 803), please go to
regarding the reporting of adverse events under the MDR regulation (2) CFR Part of regarding the reporting of adverse evens ander the healthuit.htm for the CDRH's Office of Illtp://www.lua.go/iometrics/Division of Postmarket Surveillance.
If you have any questions regarding the content of this letter, please contact Jeffrey Ballyns at (301) 796-6105.
Sincerely Yours,
Marshall D. O'Hara, for.
Janine M. Morris 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)
Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Number K122327
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Image /page/6/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "G" and "E" intertwined within a circle. The letters are stylized and connected, creating a unique and recognizable design.
#### 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. Combinations identified by "N" are new while "P" represents those previously cleared with the unmodified Voluson E6/E8ExpervE10. In a similar manner, "E'' represents combinations added to the unmodified Voluson E6/E8/E8Expert/E10 via Guidance Appendix E. This modification did not alter the previously cleared system level indications or clinical applications.
*(Division Sign-Off)*
Division of Radiological Devices
510k K122337
DIVD
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#### Diagnostic Ultrasound Indications for Use Form GE Voluson E6/E8/E8Expert/E10 Ultrasound System
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|-------------------|--------------------|------------------|--------------------|---------------------|----------------|------------------|
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color#<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[Notes] |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics(7) | P | P | P | P | P | P | P | P | P | P | [5,6,9] |
| Abdominal(1) | P | P | P | P | P | P | P | P | P | P | [5,6,9] |
| Pediatric | P | P | P | P | P | P | P | P | P | P | [5,6,9] |
| Small Organ[2] | P | P | P | P | P | P | P | P | P | P | [5] |
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | P | [5] |
| Adult Cephalic | P | P | P | P | P | P | P | P | P | P | [5] |
| Cardiac[3] | P | P | P | P | P | P | P | P | P | P | [5,6,9] |
| 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 | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: {1} Abdominal includes renal, GYN/Pelvic.
[1] Addonillial inolaoo renal, o Press, 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
[5] Elastography Intagrity - Listion)
[1] 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)
Aluhul DOTK
(Division Sign-Off)
(Division Sign-Off)
Division of Radiological Devices
K122389
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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 in a stylized, circular design. The logo is black and white, with the letters and the surrounding circle appearing in black against a white background.
#### Diagnostic Ultrasound Indications for Use Form GE Voluson E6/E8/E8Expert/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 Application<br><i>Anatomy/Region of Interest</i> | 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 | | | | | | | | | | | |
| 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
[5] 3D/4D Imaging Mode
[6] Includes imaging of guidance of biopsy (3D/4D)
[7] Includes infertility monitoring of follicle development
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Prescription User (Per 21 CFR 801.109)
*(Division Sign-Off)*
Division Sign-Off)
Division of Radiological Devices
K1aa337
18
-3 0
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Image /page/9/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 logo is black and white.
T
510(k) Premarket Notification Submission
# Diagnostic Ultrasound Indications for Use Form GE Voluson E6/E8/E8Expert/E10 with RAB4-8-D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application<br>Anatomy/Region of Interest | Mode of Operation | | | | | | | | Other<br>[Notes] | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-------------------|------------------|---------------------|----------------|
| | 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 |
| Ophthalmic | | | | | | | | | P | P | [5,6] |
| 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
[1] Abdominal includes renal, GYN/Pelvic, Urology Notes:
[5] 3D/4D Imaging Mode
[6] Includes imaging of guidance of biopsy (3D/4D)
[0] Includes infertility monitoring of follicle development
[7] Includes infertility monitoring of follicle development
[1] Includes intertility monitoring of Ibincie development
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/ColorPWD or CWD, B/B/E/R/S/F/
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Slan of Radiolo 210k
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Image /page/10/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circular shape. The logo is in black and white.
# GE Healthcare
510(k) Premarket Notification Submission
# Diagnostic Ultrasound Indications for Use Form GE Voluson E6/E8/E8Expert/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 Application<br>Anatomy/Region of Interest | B | M | PW Doppler | CW Doppler | Color Doppler | Color M Doppler | Power Doppler | Combined Modes* | Harmonic Imaging | Coded Pulse | Other (Notes) |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics[7] | P | P | P | | P | P | P | P | P | P | [5,6,9] |
| Abdominal[1] | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ[2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac[3] | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal[8] | P | P | P | | P | P | P | P | P | P | [5,6,9] |
| Transvaginal | P | P | P | | P | P | P | P | P | P | [5,6,9] |
| Transuretheral | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
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
[*] 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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*(Division Sign-Off)*
Division of Radiological
Ivision of Radiological Devices 510k
{11}------------------------------------------------
Image /page/11/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "G" and "E" intertwined in a stylized, circular design. The logo is black and white and has a vintage look.
# GE Healthcare
510(k) Premarket Notification Submission
# Diagnostic Ultrasound Indications for Use Form
#### GE Voluson E6/E8/E8Expert/E10 with RNA5-9-D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|------------------|
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[Notes] |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics[7] | P | P | P | P | P | P | P | P | P | P | [5,6] |
| Abdominal[1] | P | P | P | P | P | P | P | P | P | P | [5,6] |
| Pediatric | P | P | P | P | P | P | P | P | P | P | [5,6] |
| Small Organ [2] | P | P | P | P | P | P | P | P | P | P | [5,6] |
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | P | [5] |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac[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] |
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | P | P | P | [5,6] |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| Exam Type. Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal [8] | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
[1] Abdominal is Neonatal and pediatric Notes:
[2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediativ and neonatal patients
[3] Cardiac is Neonatal and Pediatric.
[5] 3D/4D Imaging Mode
[6] Includes imaging of guidance of biopsy (3D/4D)
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Prescription User (Per 21 CFR 801.109)
(Division Sign-off)
510
21
{12}------------------------------------------------
Image /page/12/Picture/0 description: The image shows a black and white logo of General Electric (GE). The logo consists of the letters 'G' and 'E' intertwined in a circular design. The letters are stylized and have a flowing, cursive appearance. The logo is simple and recognizable, representing the well-known multinational corporation.
# Diagnostic Ultrasound Indications for Use Form
# GE Voluson E6/E8/E8Expert/E10 with RRE6-10-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] | | | | | | | | | | | |
| Abdominal[1] | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ[3] | | | | | | | | | | | |
| 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 | 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)
[8] Includes urology/prostate
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-510k
{13}------------------------------------------------
# Diagnostic Ultrasound Indications for Use Form GE Voluson E6/E8/E8Expert/E10 with AB2-7-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 | | | | | | | | P | P | P | [6] |
| Fetal / Obstetrics[7] | P | P | P | | P | P | P | P | P | P | [6] |
| Abdominal[1] | P | P | P | | P | P | P | P | P | P | [6] |
| Pediatric | P | P | P | | P | P | P | P | P | P | [6] |
| Small Organ[2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac[3] | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | P | |
| Musculo-skeletal Conventional | 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 | | | | | | | | | | | |
| I anarosconic . | | | | | | | | | | | |
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
[7] Includes intertlify monitoring of tothere 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)
```
(Division Sign-Off)
Division of Radiological Devices
510k
f Radiological Devices
510k K122337
{14}------------------------------------------------
Image /page/14/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 logo is in black and white.
#### Diagnostic Ultrasound Indications for Use Form
#### GE Voluson E6/E8/E8Expert/E10 with 4C-D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|------------------|-----|
| Clinical Application<br>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 | [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 | 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
[1] 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)
(Division Sign-Off)
Division of Radiological Devices
510K K122337
{15}------------------------------------------------
Image /page/15/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "G" and "E" intertwined within a circular frame. The logo is in black and white and has a vintage look.
# GE Healthcare
510(k) Premarket Notification Submission
# Diagnostic Ultrasound Indications for Use Form GE Voluson E6/E8/E8Expert/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 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 Harmonic<br>Modes* | Coded<br>Pulse | Other<br>[Notes] | |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics[7] | P | P | P | | P | P | P | P | P | [6,9] | |
| Abdominal[1] | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ[2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | |…
