Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound System
Device Facts
| Record ID | K152567 |
|---|---|
| Device Name | Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound System |
| Applicant | GE Healthcare |
| Product Code | IYN · Radiology |
| Decision Date | Nov 6, 2015 |
| Decision | SESE |
| Submission Type | Special |
| 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 (including GYN); Transrectal
Device Story
Voluson E6, E8, E10 are track 3 diagnostic ultrasound systems for general radiology and OB/GYN. Systems consist of mobile console, keyboard, touch panel, and display. They use various linear, curved, and matrix phased array transducers for real-time 2D/3D/4D imaging. Operators (clinicians) use the system to acquire, analyze, and store ultrasound images. Data is processed for diagnostic review and reporting. Features include SonoAVC Antral for follicle counting and DICOM networking. Output aids clinical decision-making by providing anatomical visualization and blood flow analysis. Benefits include non-invasive diagnostic assessment of various body regions and fetal development.
Clinical Evidence
No clinical data required. Substantial equivalence supported by bench testing, including acoustic output, biocompatibility, cleaning/disinfection effectiveness, thermal, electrical, electromagnetic, and mechanical safety testing.
Technological Characteristics
Mobile ultrasound console with linear, curved, and matrix phased array transducers. Supports B, M, PW/CW Doppler, Color/Power Doppler, 3D/4D imaging, and harmonic imaging. Complies with AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, NEMA UD 2/3, and ISO 10993-1. Connectivity via DICOM. Software includes SonoAVC Antral algorithm.
Indications for Use
Indicated for diagnostic ultrasound imaging and fluid flow analysis in fetal/OB, abdominal, GYN, pelvic, infertility monitoring, pediatric, small organ (breast, testes, thyroid, etc.), neonatal/adult cephalic, cardiac, musculoskeletal, peripheral vascular, transvaginal, and transrectal 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_E10 Diagnostic Ultrasound System (K142472)
Related Devices
- K122327 — VOLUSON E6/E8/E8EXPERT/E10 · GE Healthcare · Sep 21, 2012
- K181985 — Voluson E6, Voluson E8, Voluson E10 · GE Healthcare · Nov 15, 2018
- K142472 — Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound Systems · GE Healthcare · Feb 10, 2015
- K113758 — VOLUSON E6/E8/E8EXPERT/E10 · GE Healthcare · Jan 10, 2012
- K162269 — Voluson E6, Voluson E8, Voluson E10 · GE Healthcare · Oct 3, 2016
Submission Summary (Full Text)
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine and health. The caduceus is composed of three human profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 6, 2015
GE Healthcare % Ms. Ayesha Pergadia Regulatory Affairs Leader 3114 N. Grandview Blvd. WAUKESHA WI 53188
Re: K152567
Trade/Device Name: Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: October 16, 2015 Received: October 20, 2015
Dear Ms. Pergadia:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
## Indications for Use
510(k) Number (if known)
K152567
Device Name
Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound Systems
Indications for Use (Describe)
The device is a general purpose ultrasound system. Specific clinical applications remain the same as previously cleared: Fetal/OB; Abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatric; Small Organ (breast, testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Musculo-skeletal Conventional and Superficial; Peripheral Vascular; Transvaginal (including GYN); Transrectal
Type of Use (Select one or both, as applicable)
> Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement on last page.
#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
#### FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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This section applies only to requirements of the Paperwork Reduction Act of 1995.
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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 proposed Voluson E Series system and for all of its probe/mode combinations. Combinations identified as "P" represents those previously cleared with another GE Ultrasound system. This modification does not add to indications to the previously cleared system level or transducer indications or clinical applications.
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## Diagnostic Ultrasound Indications for Use Form GE Voluson E Series (Voluson E6 / Voluson E8 / Voluson E10)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|-------------------|--------------------|------------------|-------------------|---------------------|----------------|------------------|--|
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color#<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[Notes] | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal / Obstetrics[7] | P | P | P | P | P | P | P | P | P | P | [5,6,9] | |
| Abdominal[1] | P | P | P | P | P | P | P | P | P | P | [5,6,9] | |
| Pediatric | P | P | P | P | P | P | P | P | P | P | [5,6,9] | |
| Small Organ[2] | P | P | P | P | P | P | P | P | P | P | [5,6,9] | |
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | P | [5] | |
| Adult Cephalic | P | P | P | P | P | P | P | P | P | P | | |
| Cardiac[3] | P | P | P | P | P | P | P | P | P | P | [5] | |
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | P | [5,6,9] | |
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | P | P | P | [5,6,9] | |
| Musculo-skeletal Superficial | P | P | P | P | P | P | P | P | P | P | [5,6,9] | |
| Other | | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal[8] | P | P | P | P | P | P | P | P | P | P | [5,6,9] | |
| Transvaginal[10] | P | 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: [1] Abdominal includes renal, GYN/Pelvic, Urology
[2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients
[3] Cardiac is Adult and Pediatric
[5] 3D/4D Imaging Mode
[6] Includes imaging of guidance of biopsy
[7] Includes infertility monitoring of follicle development
[8] Includes urology/prostate
[9] Elastography imaging- Elasticity
[10] Transvaginal includes GYN
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD
[*] Voluson E10 Only: 4D color Doppler (only with eM6C probe and eM6C G2)
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## GE Voluson E Series 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>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 | | | | | | | | | | | | |
| Small Organ[2] | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac[3] | | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | | |
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | P | P | P | [ 5,6] | |
| Musculo-skeletal Superficial | | | | | | | | | | | | |
| Other | | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
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)
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## GE Voluson E Series 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[10] | P | P | P | | P | P | P | P | P | P | [5,6,9] | |
| Transuretheral | | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
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
[10] Transvaginal includes GYN
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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## GE Voluson E Series with 4C-D Transducer
| | 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 | | | | | | | | | | | | |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
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)
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## GE Voluson E Series 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 | 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 | [ 6,9] |
| Abdominal[1] | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ[2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac[3] | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal[8] | P | P | P | | P | P | P | P | P | P | [ 6,9] |
| Transvaginal[10] | P | P | P | | P | P | P | P | P | P | [ 6,9] |
| Transuretheral | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
[6] Includes imaging of guidance of biopsy (2D) Notes:
[7] Includes infertility monitoring of follicle development
[8] Includes urology/prostate
[9] Elastography Imaging- Elasticity
[10] Transvaginal includes GYN
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD
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## GE Voluson E Series with RSP6-16-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 | [5,6] | |
| Small Organ[2] | P | P | P | | P | P | P | P | P | P | [5,6] | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac[3] | | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | P | P | P | [5,6] | |
| Musculo-skeletal Conventional | P | P | P | | P | P | P | P | P | P | [5,6] | |
| Musculo-skeletal Superficial | P | P | P | | P | P | P | P | P | P | [5,6] | |
| Other | | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal[8] | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients
[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)
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## GE Voluson E Series with RIC6-12-D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|------------------|
| Clinical Application<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] | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ[2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac[3] | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal[8] | P | P | P | | P | P | P | P | P | P | [5,6] |
| Transvaginal[10] | P | P | P | | P | P | P | P | P | P | [5,6] |
| Transuretheral | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
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
[10] Transvaginal includes GYN
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD
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{12}------------------------------------------------
## GE Voluson E Series with 9L-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 | P | [6] |
| Abdominal[1] | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | P | P | P | [6] |
| Small Organ[2] | P | P | P | P | P | P | P | P | P | P | [6] |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac[3] | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | P | [6] |
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | P | P | P | [6] |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients
[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)
{13}------------------------------------------------
## GE Voluson E Series with 11L-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] | | | | | | | | | | | |
| Abdominal[1] | | | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | P | P | P | [6,9] |
| Small Organ[2] | P | P | P | | P | P | P | P | P | P | [6,9] |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac[3] | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | P | P | P | [6,9] |
| Musculo-skeletal Conventional | P | P | P | | P | P | P | P | P | P | [6,9] |
| Musculo-skeletal Superficial | P | P | P | | P | P | P | P | P | P | [6,9] |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
[2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients Notes:
[6] Includes imaging of guidance of biopsy (2D)
[9] Elastography Imaging- Elasticity
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD
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{14}------------------------------------------------
## GE Voluson E Series with C1-5-D Transducer
Mode of Operation Clinical Application PW CW Color Color M Power Combined Harmonic Other Coded B M Imaging Doppler Doppler Doppler Doppler Doppler Modes Pulse [Notes) Anatomy/Region of Interest Ophthalmic P b P Р P P Р Р P P [6] Fetal / Obstetrics[7] Abdominal[1] P P P P P P P P P P [6] Pediatric Small Organ[2] Neonatal Cephalic Adult Cephalic Cardiac[3] P P P P P P P P P P [6] Peripheral Vascular Musculo-skeletal Conventional Musculo-skeletal Superficial Other Exam Type, Means of Access Transesophageal Transrectal Transvaginal Transuretheral Intraoperative Intraoperative Neurological Intravascular Laparoscopic
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
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)
{15}------------------------------------------------
## GE Voluson E Series with ML6-15-D Transducer
| | 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] | | | | | | | | | | | | |
| Abdominal[1] | | | | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | P | P | P | [6,9] | |
| Small Organ[2] | P | P | P | | P | P | P | P | P | P | [6,9] | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac[3] | | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | P | P | P | [6,9] | |
| Musculo-skeletal Conventional | P | P | P | | P | P | P | P | P | P | [6,9] | |
| Musculo-skeletal Superficial | P | P | P | | P | P | P | P | P | P | [6,9] | |
| Other | | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under Appendix E
[2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients Notes:
[6] Includes imaging of guidance of biopsy (2D)
[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)
{16}------------------------------------------------
## GE Voluson E Series with RM6C 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] | |
| 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)
{17}------------------------------------------------
## GE Voluson E Series with 3Sp-D Transducer
| | 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 | | |
| 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] | | | | | |…
