VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM
Device Facts
| Record ID | K112213 |
|---|---|
| Device Name | VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM |
| Applicant | GE Healthcare |
| Product Code | IYN · Radiology |
| Decision Date | Sep 1, 2011 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal / Obstetrics; 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: Vascular: Transvaginal: Transrectal: and Peripheral Intraoperative (abdominal, PV and neurological).
Device Story
The Voluson E6/E8/E8Expert/E10 is a mobile diagnostic ultrasound system for general radiology and OB/GYN. It uses linear, curved linear, and matrix phased array transducers (mechanical/electronic scanning) to acquire ultrasound signals. The system processes these inputs to provide real-time 2D, 3D, and 4D imaging, along with Doppler flow analysis. Operated by clinicians in clinical settings, the system features a console with a touch panel and display for image visualization and analysis. It supports DICOM networking for data management. The device aids in clinical decision-making by providing high-performance visualization of anatomy and blood flow, facilitating diagnostic assessments and biopsy guidance. Patient benefits include non-invasive diagnostic imaging and real-time monitoring of fetal development and other pathologies.
Clinical Evidence
No clinical studies were required to support substantial equivalence. The device was evaluated through bench testing, including acoustic output, biocompatibility, cleaning/disinfection effectiveness, and thermal, electrical, electromagnetic, and mechanical safety testing.
Technological Characteristics
Mobile console with keyboard and touch panel. Utilizes linear, curved linear, and matrix phased array transducers. Supports B, M, PW/CW Doppler, Color/Power Doppler, 3D/4D, and harmonic imaging. Connectivity via DICOM. Biocompatible patient-contact materials. Software-based image processing and analysis.
Indications for Use
Indicated for diagnostic ultrasound imaging or fluid flow analysis in fetal/obstetrics, abdominal (including GYN/pelvic/infertility), pediatric, small organ (breast/testes/thyroid/salivary/lymph), neonatal/adult cephalic, cardiac (adult/pediatric), musculoskeletal (conventional/superficial), peripheral vascular, transvaginal, transrectal, and intraoperative (abdominal/PV/neurological) 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 Diagnostic Ultrasound System (K101236)
- Vivid E9 Diagnostic Ultrasound System (K101149)
Related Devices
- K113758 — VOLUSON E6/E8/E8EXPERT/E10 · GE Healthcare · Jan 10, 2012
- K122327 — VOLUSON E6/E8/E8EXPERT/E10 · GE Healthcare · Sep 21, 2012
- K142472 — Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound Systems · GE Healthcare · Feb 10, 2015
- K131267 — VOLUSON E6/E8/E8EXPERT/E8EXPERT LIMITED EDITION/E10 · GE Healthcare · Jun 19, 2013
- K132913 — VOLUSON E6 / E8 / E8EXPERT / E8EXPERT LIMITED EDITION / E10 · GE Healthcare · Nov 8, 2013
Submission Summary (Full Text)
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SEP - 1 2011
GE Healthcare
510(k) Premarket Notification Submission
#### 510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided.
August 1, 2011 Date: Submitter: GE Healthcare [GE Healthcare Austria GmbH & Co OG] Tiefenbach 15 Zipf, Austria 4871 Bryan Behn Primary Contact Person: Regulatory Affairs Manager GE Healthcare T:(414)721-4214 F:(414)918-8275 Roland Kuntscher Secondary Contact Person: Regulatory Affairs Specialist GE Healthcare Austria GmbH & Co OG T:(++43)7682-3800-660 F:(++43)7682 3800-47 Voluson E6/E8/E8Expert/E10 Diagnostic Ultrasound System Device: Trade Name: Common/Usual Name: Voluson E6/E8/E8Expert/E10 Classification Names: Class II Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-IYN Product Code: Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX Predicate Device(s): K101236 Voluson E6/E8/E8Expert Diagnostic Ultrasound System K 101149 Vivid E9 Diagnostic Ultrasound System The Voluson E6/E8/E8Expert/E10 system is a full-featured Track Device Description: 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. The device is a general purpose ultrasound system. Specific Intended Use:
clinical applications remain the same as previously cleared:
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Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circular frame. The letters are stylized and appear to be handwritten or cursive. The logo is black and white, with the letters and frame being black and the background being white.
Substantial Equivalence:
## GE Healthcare
510(k) Premarket Notification Submission
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: 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.
Summary of Non-Clinical Tests: Determination of
> 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.
Summarv 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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of a bird or abstract human figure with outstretched arms, symbolizing care and protection.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Mr. Bryan Behn Regulatory Affairs Manager GE Healthcare 9900 W Innovation Drive WAUWATOSA WI 53226
1 2011
#### Re: K112213
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: August 1, 2011
- Received: August 2, 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 Voluson E6/E8/E8Expert/E10 Diagnostic Ultrasound System, as described in your premarket notification:
| Transducer Model Number | | | |
|-------------------------|-----------|----------|-----------|
| RAB2-5-D | PA6-8-D | 3S-D | RRE5-10-D |
| RAB4-8-D | SP10-16-D | P2D | RM14L |
| RIC5-9-D | RSP6-16-D | P6D | 3Sp-D |
| RNA5-9-D | RIC6-12-D | M6C | C4-8-D |
| RRE6-10-D | RAM3-8 | 11L-D | RAB6-D |
| AB2-7-D | RSM5-14 | C1-5-D | eM6C |
| 4C-D | 9L-D | ML6-15-D | |
| IC5-9-D | M12LW | RM6C | |
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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 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.html 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/ReportaProblem/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 Robert Ochs, Ph.D. at (301) 796-6661.
Sincerely Yours.
Mary S Patel
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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Image /page/4/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circular border. The letters and the border are solid black, creating a strong contrast against the white background. The logo is a well-known symbol representing the multinational conglomerate.
K112213 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-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Number K112213
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Image /page/5/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 and the border are black, creating a strong contrast.
## 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/E8/E8Expert. In a similar manner, "E" represents combinations added to the unmodified Voluson E6/E8/E8Expert via Guidance Appendix E. This modification did not alter the previously cleared system level indications or clinical applications.
Mary S. Pastel
510K K112213
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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, and there are decorative swirls around the outer edge of the circle.
#### 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 | 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] | 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 | | | | | | | | | | | | |
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.
Prescription User (Per 21 CFR 801.109)
[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 (OIV
Mary S. Pettit
vision Sion-Off of Radiological Device tic Device Evaluation and Safety nifice of in Vitro Diag
510K K112213
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Image /page/7/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circle. There are three decorative swirls around the letters inside the circle.
## 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:
| Clinical Application<br>Anatomy/Region of Interest | Mode of Operation | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|------------|------------|---------------|-----------------|---------------|-----------------|------------------|-------------|---------------|
| | 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
[1] Abdominal includes renal, GYN/Pelvic 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)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mary S. Padell
insion Sion-Of of Radiological Dev ation and Safety
K112213
510K
16
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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 frame. The letters and the frame are black, creating a strong contrast against the white background.
## 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 | 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 | [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)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mary Slatel
Office of I on and Safety
K112213
510K.
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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 letters and the border are solid black, contrasting with the white background.
## 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 | 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] | 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
[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
[*] 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. Patel
(Division Sign-Off)
Office of In
510K K112213
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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 frame. The letters and the frame are solid black, contrasting with the white background. The logo is a well-known symbol associated with the multinational conglomerate company.
#### 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, pediatric and neonatal patients
[3] Cardiac is Neonatal and Pediatric.
[5] 3D/4D Imaging Mode
[6] Includes imaging of guidance of biopsy (3D/4D)
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Prescription User (Per 21 CFR 801.109)
Mary S Pastl
(Division Sign-Off)
Division of Radiological Devices
Office of In aluation and Safety
510K K112213
{11}------------------------------------------------
Image /page/11/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a stylized circular shape. The letters and the surrounding shape are in black, contrasting with a white background. The logo is a well-known symbol associated with the General Electric company.
## 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[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 | 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)
Mary S. Patil
Onvision Sign-C Division of Radiological De Office of In Vitro Diagnostic Device Evaluation and Safety
510K K112213
{12}------------------------------------------------
Image /page/12/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, creating a strong contrast. The logo has a vintage or classic appearance.
## 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 | | | | | | | | | | | | |
| 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 | | | | | | | | | | | | |
| 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 | | | | | | | | | | | | |
| 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)
Mary S. Pastel
of Radiological De nivisio Office of In Vitro Di
K112213
510K
{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, intertwined script, enclosed within a circular border. The background is black, and the letters and border are white, creating a high-contrast design. The logo is a well-known corporate symbol.
## 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 | [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)
Mary Patil
(Division Sign Off)
Division q Radininnin Office of In Vitro Diag
S10K K112213
{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 black and white.
## 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:
| 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 | [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 | 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
[*] 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)
Mary S. Pastil
(Division Sign-Off)
Office of In aluation and Safety
510K K112213
{15}------------------------------------------------
Image /page/15/Picture/0 description: The image shows the General Electric (GE) logo, which consists of the letters 'GE' intertwined within a circular frame. The letters are stylized and connected, creating a unique and recognizable design. The logo is presented in black and white, with the letters and the inner part of the circle filled in black, while the background is white. The circular frame surrounding the letters has decorative elements, adding to the overall aesthetic appeal of the logo.
## Diagnostic Ultrasound Indications for Use Form
#### GE Voluson E6/E8/E8Expert/E10 with PA6-8-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] | 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 | 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; E = added under Appendix E
[1] Abdominal is Neonatal , pediatric and obstetrics
[3] Cardiac is Adult and Pediatric.
Notes:
[*] 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)
Mary S. Patil
(Division Sign-Off)
Division of Ra Office of In luation and Safety
510K K112213
{16}------------------------------------------------
Image /page/16/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 and the circle are black, creating a strong contrast.
#### Diagnostic Ultrasound Indications for Use Form
#### GE Voluson E6/E8/E8Expert/E10 with SP10-16-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 | P | P | P | | P | P | P | P | P | P | [6] |
| Small Organ[2] | P | P | P | | P | P | P | P | P | P | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac[3] | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | P | P | P | [6] |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | P | P | P | | P | P | P | P | P | P | [6] |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal[8] | | | | | | | | | | | |
| Transvaginal | | | | | | | | | |…
