VOLUSON E6/E8/E8 EXPERT DIAGNOSTIC ULTRASOUND SYSTEM MODEL: H48681BD/ H48681BX/ H48681BM
Device Facts
| Record ID | K101236 |
|---|---|
| Device Name | VOLUSON E6/E8/E8 EXPERT DIAGNOSTIC ULTRASOUND SYSTEM MODEL: H48681BD/ H48681BX/ H48681BM |
| Applicant | GE Healthcare |
| Product Code | IYN · Radiology |
| Decision Date | Feb 8, 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/OB; Abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatric; Small Organ (breast, testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Musculo-skeletal Conventional and Superficial; Peripheral Vascular: Transvaginal; Transrectal; and Intraoperative (abdominal, PV and neurological).
Device Story
Voluson E6/E8/E8 Expert is a mobile, full-featured diagnostic ultrasound system for general radiology and OB/GYN. It acquires ultrasound data via various linear, curved, and matrix phased array transducers. The system processes these inputs to provide 2D, 3D, and 4D imaging, Doppler, and M-mode analysis. It includes Elastography mode (extracts strain information to color-code tissue stiffness) and Contrast Imaging (for cardiac LVO). Operated by clinicians in clinical settings, the system displays images on a console monitor. Output supports clinical decision-making by providing anatomical visualization and mechanical tissue property assessment. Benefits include enhanced diagnostic visualization and guidance for procedures like biopsies.
Clinical Evidence
No clinical studies were required to support substantial equivalence. The device relies on bench testing, including module verification, system integration, and final acceptance testing, to demonstrate safety and performance.
Technological Characteristics
Mobile console with keyboard, touch panel, and display. Supports linear, curved, and matrix phased array transducers. Imaging modes: B, M, PW/CW Doppler, Color/Power Doppler, 3D/4D, Harmonic, Coded Pulse. Features Elastography (strain-based tissue stiffness) and Contrast Imaging (LVO). Biocompatible patient-contact materials. Networking/DICOM connectivity. Software-based image processing.
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, transrectal, transvaginal, 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 E8 Diagnostic Ultrasound System (K061682)
- GE Logiq E9 (K092271)
Related Devices
- K113758 — VOLUSON E6/E8/E8EXPERT/E10 · GE Healthcare · Jan 10, 2012
- K122327 — VOLUSON E6/E8/E8EXPERT/E10 · GE Healthcare · Sep 21, 2012
- K132913 — VOLUSON E6 / E8 / E8EXPERT / E8EXPERT LIMITED EDITION / E10 · GE Healthcare · Nov 8, 2013
- K112213 — VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM · GE Healthcare · Sep 1, 2011
- K181985 — Voluson E6, Voluson E8, Voluson E10 · GE Healthcare · Nov 15, 2018
Submission Summary (Full Text)
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K101236
FEB - 8 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: |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | April 30, 2010 |
| Submitter: | GE Healthcare [GE Medical Systems Ultrasound and Primary<br>Care Diagnostics, LLC]<br>9900 Innovation Dr<br>Wauwatosa, WI 53226 |
| Primary Contact Person: | Bryan Behn<br>Regulatory Affairs Manager<br>GE Healthcare, GE Medical Systems Ultrasound and Primary<br>Care Diagnostics, LLC.]<br>T:(414)721-4214<br>F:(414)918-8275 |
| Secondary Contact Person: | Jim Turner<br>Regulatory Affairs Manager America's Service<br>GE Healthcare, GE Medical Systems Ultrasound and Primary<br>Care Diagnostics, LLC<br>T:(262) 544-3359<br>F:(414)908-9225 |
| Device:<br>Trade Name: | Voluson E6/E8/E8 Expert Diagnostic Ultrasound System |
| Common/Usual Name: | Voluson E6/E8/E8 Expert |
| 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): | K061682 Voluson E8 Diagnostic Ultrasound System |
| Device Description: | The Voluson E6/E8/E8Expert BT10 system is a full-featured<br>Track 3 ultrasound system, primarily for general radiology use<br>and 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 scanning transducers, which provide highly<br>accurate realtime three dimensional imaging supporting all<br>standard acquisition modes. |
Image /page/0/Picture/5 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, contrasting with the white background.
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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 and enclosed within a circle. The letters and the circle are white, while the background is black. The logo has a vintage or classic appearance.
## GE Healthcare
#### 510(k) Premarket Notification Submission
The device is a general purpose ultrasound system. Specific Intended Use: clinical applications remain the same as previously cleared: Fetal/OB; Abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatric; Small Organ (breast, testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Musculo-skeletal Conventional and Superficial; Peripheral Vascular: Transvaginal; Transrectal; and Intraoperative (abdominal, PV and neurological).
The Voluson E6/E8/E8 Expert employs the same fundamental Technology: scientific technology as its predicate devices. In additions to the original 21 transducers commercially released: RAB2-5-D. RAB4-8-D, RIC5-9-D, RNA5-9-D, RRE6-10-D, AB2-7-D, 4C-D, IC5-9-D, PA6-8-D, SP10-16-D, RSP6-16-D, RIC6-12-D, M12LW, RAM3-8, RSM5-14, 9L-D, 3S-D, P2D, P6D, 11L-D, M6C the Voluson E6E8/E8 Expert will be released with these additional 7 transducers: C1-5-D. ML6-15-D. RRE5-10-D. RM6C, RM14L, C4-8-D, 3Sp-D.
Additional Features Description:
1. Elastography Mode on the Voluson E6/E8/E8 Expert is similar to the Elastography imaging mode on the GE Logiq E9 (K092271). Elastography is a method to extract and display mechanical properties of tissue. This imaging method involves applying manual pressure with the hand on the transducer. The actual imaging sequence is similar to the B mode sequence except that the system will acquire the RF signal instead of acquiring B mode data. The algorithm extracts a strain value information for every point of the image. The Elastography image then colorcodes the stiff versus softer structures. The clinical benefits of elastography are still under evaluation. This feature allows the user to be able to determine whether or not a structure inside the patient is stiffer than another one; no clinical diagnostic claims are being made.
2. Contrast Imaging with contrast agent - Volume Contrast Imaging (VCI) is a feature which is already cleared on the Voluson E8, K061682 which improves the contrast resolution and the signal to noise ratio (without the use of contrast agents for radiological use).
The use of FDA approved contrast agents in 2D and 3D Volume mode for Cardiac LVO application is part of the modification and is already implemented and cleared on the GE Logiq E9 Ultrasound System (K092271). Injected contrast agents re-emit
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Image /page/2/Picture/0 description: The image shows the General Electric (GE) logo, which is a circular emblem with the letters "GE" intertwined in the center. The letters are stylized and connected, creating a unique and recognizable design. The logo is black and white, with the letters and the surrounding circle in black against a white background. The logo is a well-known symbol associated with the General Electric company.
Substantial Equivalence:
#### GE Healthcare 510(k) Premarket Notification Submission
incident acoustic energy at a harmonic frequency much more efficiently than the surrounding tissue.
Determination of Summary of Non-Clinical Tests:
> The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic, and mechanical safety, and has been found to conform with applicable medical device safety standards. The Voluson E6/E8/E8 Expert BT10 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 BT10, did not require clinical studies to support substantial equivalence.
- GE Healthcare considers the Voluson E6/E8/E8 Expert to be as Conclusion: safe. as effective, and performance is substantially equivalent to the predicate device(s).
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.
FEB - 8 2011
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Mr. Bryan Behn Regulatory Affairs Manager GE Healthcare, GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC 9900 Innovation Dr. RP-2138 WAUWATOSA WI 53226
Re: K101236 Trade/Device Name: Voluson E6/E8/E8 Expert 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: September 9, 2010 Received: September 10, 2010
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 Diagnostic Ultrasound System, as described in your premarket notification:
Transducer Model Number
| RAB2-5-D | IC5-9-D | 9L-D | C1-5-D |
|-----------|-----------|-------|-----------|
| RAB4-8-D | PA6-8-D | M12LW | ML6-15-D |
| RIC5-9-D | SP10-16-D | 3S-D | RM6C |
| RNA5-9-D | RSP6-16-D | P2D | RRE5-10-D |
| RRE6-10-D | RIC6-12-D | P6D | RM14L |
| AB2-7-D | RAM3-8 | M6C | 3Sp-D |
| 4C-D | RSM5-14 | 11L-D | C4-8-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 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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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/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 Shahram Vaezy at (301) 796-6242.
Sincerely Yours.
Muhan D'Hern Lan
Mary Pastel, ScD. 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): K 101236
Voluson E6/E8/E8 Expert 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)
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Concurrence of CDRH, Office of Device Bealingtion (ODE) OJIVI
---
(Division Sign-Off)
Office of In Vitro Diagnostic
510K K101236
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#### Indications for Use Forms
The following forms represent indications with clinical applications and exam types along with the modes of operation for the Voluson E6/E8/E8Expert BT10 system and for all of its probe/mode combinations. Combinations identified "P" represents those previously cleared with the unmodified Voluson E8. In a similar manner, "E" represents combinations added to the unmodified Voluson E8 via Guidance Appendix E. This modification did not alter the previously cleared system level indications, clinical applications or modes of operation.
Mhhal D'Ohm
(Division Sign-Off)
(Division Sign Division of Radiological Devices Office of In Vitro Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K16123Ce
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#### Diagnostic Ultrasound Indications for Use Form GE Voluson E6/E8/E8Expert 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 | [5,6,9] |
| 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(1) | P | P | P | P | P | P | P | P | P | P | [5,10] |
| 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, 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
[10] contrast Imaging (contrast agent for LVO)
[*] Combined modes are BIM, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
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Concurrence of CDRH, Office of Bevice Evaluation (ODE
F2
(Division Sign-Off)
Office of In Vitro Diag
510K: K101236
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## Diagnostic Ultrasound Indications for Use Form GE Voluson E6/E8/E8Expert 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<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 | | | | | | | | | | | |
| 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.
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Concurrence of CDRH, Office of Device Evaluation (ODE) OIVD
Prescription User (Per 21 CFR 801.109)
Office of In aluation and
510K K101236
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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 in a stylized, cursive font. The letters are enclosed within a circular border, and there are small, leaf-like shapes positioned around the circle's perimeter. The logo is presented in black and white.
#### Diagnostic Ultrasound Indications for Use Form GE Voluson E6/E8/E8Expert with RAB4-8-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<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.
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Concurrence of CDRH, Office of Dovice Evaluation (ODE)
Prescription User (Per 21 CFR 801.109)
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(Division Sign-Off)
tion and Safety
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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 and enclosed within a circle. The letters and the circle are black, creating a strong contrast against the white background.
#### Diagnostic Ultrasound Indications for Use Form GE Voluson E6/E8/E8Expert 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<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 | [5,6,9] |
| 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)
Concurrence of CDRH, Office of Device Evaluation (ODE) (
(Division Sign Off)
on and Safety
20 510K K10123C
{11}------------------------------------------------
## Diagnostic Ultrasound Indications for Use Form GE Voluson E6/E8/E8Expert 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 | [5,10] |
| 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
Notes: [1] Abdominal is Neonatal and pediatric
[2] Small organ includes breast, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients
[3] Cardiac is Neonata! and Pediatric.
[5] 3D/4D Imaging Mode
[6] Includes imaging of guidance of biopsy (3D/4D)
[10] Contrast Imaging (contrast agent for LVO)
[*] 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 Beviee Evaluation (QBE) Of
Markus D. Kirk
(Division Sign-Off, on of Radiological Devices Office of In Vitro Diagnostic ice Evaluation and Safety
F3` 510K K101236
{12}------------------------------------------------
Image /page/12/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 with curved lines, giving them a classic, almost calligraphic appearance. The logo is presented in black and white, with the letters and the frame appearing in black against a white background. The overall design is simple yet recognizable, reflecting the brand's long history and established presence.
## Diagnostic Ultrasound Indications for Use Form GE Voluson E6/E8/E8Expert with RRE6-10-D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application<br><i>Anatomy/Region of Interest</i> | Mode of Operation | | | | | | | | | | | |
|-----------------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|------------------|--|
| | 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
Notes: [5] 3D/4D Imaging Mode
[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 Beview-Evaluation (OBE) Of U
Prescription User (Per 21 CFR 801.109)
```
(Division Sign-Off)
22
510
{13}------------------------------------------------
Image /page/13/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 logo is black and white.
#### Diagnostic Ultrasound Indications for Use Form GE Voluson E6/E8/E8Expert 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] | P | P | P | | P | P | P | P | P | P | [6] |
| 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 Beview Evaluation (ODE) O TV V
Division of Radiological Devices
510K K101236
{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 letters and the border are solid black, contrasting with the 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 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
Notes: [1] Abdominal includes renal, GYN/Pelvic, Urology
[6] Includes imaging of guidance of biopsy (2D)
[7] Includes infertility monitoring of follicle development
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
24
Concurrence of CDRH, Office of Device Evaluation (ODE)
Naishe D'Khm
(Division Sign-Off)
of Redictor uation and Safety Office of In
510K K16123C
{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 in a stylized, cursive font. The letters are enclosed within a circular border. The logo is black and white.
# Diagnostic Ultrasound Indications for Use Form
#### GE Voluson E6/E8/E8Expert 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<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[Notes] |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics[2] | P | P | P |…
