(29 days)
Not Found
No
The document does not mention AI, ML, or related terms, nor does it describe features or performance metrics typically associated with AI/ML-powered devices.
No
The device is described as a "general-purpose ultrasound system" intended for "Diagnostic ultrasound imaging or fluid flow analysis," indicating its use for diagnosis rather than therapy.
Yes
The "Intended Use" section explicitly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body," and the predicate device names also include "Diagnostic Ultrasound System."
No
The device description explicitly states it consists of a mobile console with keyboard control panel, color LCD/TFT touch panel, color video display, optional image storage and printing devices, and utilizes various transducers. These are all hardware components, indicating it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device is a general-purpose ultrasound system. Ultrasound systems use sound waves to create images of internal body structures. They do not analyze samples taken from the body.
- Intended Use: The intended use describes diagnostic ultrasound imaging or fluid flow analysis of the human body. This involves imaging the body directly, not testing samples from it.
- Device Description: The description details a mobile console, transducers, and imaging capabilities, all consistent with an ultrasound system and not an IVD.
Therefore, the function and intended use of this device fall under the category of medical imaging, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The device is a general-purpose ultrasound system. Specific clinical applications and exam types include: Fetal (Obsterics); Abdominal (including renal and GYN/pelvic); Pediatic; Small Organ (breast, testes, thyroid, salvary gland, lymph nodes, pediatic and neonatal patients); Neonatal Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transrectal (TR); Transvaginal (TV).
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal / Obstetrics; Abdominal; Pediatric; Small Organ; Neonatal Cephalic; Adult Cephalic; Cardiac; Peripheral Vascular; Musculo-skeletal Conventional; Musculo-skeletal Superficial; Transrectal; Transvaginal.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
The systems are full-featured Track 3 ultrasound systems primarily for general radiology use and specialized for OB/GYN with particular features for realtime 3D/4D acquisition. They consist of a mobile console with keyboard control panel; color LCD/TFT touch panel, color video display and optional image storage and printing devices. They provide high performance ultrasound imaging and analysis and have comprehensive networking and DICOM capability. They utilize a variety of linear, curved linear, matrix phased array transducers including mechanical and electronic scanning transducers, which provide accurate realtime three dimensional imaging supporting all standard acquisition modes.
The device is a general purpose ultrasound system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasonic
Anatomical Site
Fetal (Obsterics); Abdominal (including renal and GYN/pelvic); Pediatic; Small Organ (breast, testes, thyroid, salvary gland, lymph nodes, pediatic and neonatal patients); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transrectal (TR); Transvaginal (TV).
Indicated Patient Age Range
Adult and pediatric
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The subject of this premarket submission, Voluson S6 / Voluson S8 / Voluson S10, did not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
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.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized representation of a human figure with three faces in profile, stacked on top of each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 25, 2016
GE Healthcare % Ms. Tracey Ortiz Regulatory Affairs Director 9900 W. Innovation Drive WAUWATOSA WI 53226
Re: K160184
Trade/Device Name: Voluson S6, Voluson S8, Voluson S10 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: January 20, 2016 Received: January 27, 2016
Dear Ms. Ortiz:
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.
1
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,
Robert Ocks
Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Image /page/2/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font in the center. There are four curved lines emanating from the circle, one at each of the cardinal directions. The logo is simple and recognizable, and it is associated with a well-known and established company.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known)
K160184
Device Name Voluson S6 / Voluson S8 / Voluson S10
Indications for Use (Describe)
The device is a general-purpose ultrasound system. Specific clinical applications and exam types include: Fetal (Obsterics); Abdominal (including renal and GYN/pelvic); Pediatic; Small Organ (breast, testes, thyroid, salvary gland, lymph nodes, pediatic and neonatal patients); Neonatal Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transrectal (TR); Transvaginal (TV).
Type of Use (Select one or both, as applicable) [x] Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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)
FORM FDA 3881 (1/14)
3
Image /page/3/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a circular frame. The frame has decorative flourishes or embellishments around the circle. The logo is presented in a blue color.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Image /page/4/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" written in a stylized script, enclosed within a blue circle. The circle has decorative swirls or flourishes around the perimeter, giving it a vintage or classic appearance.
Diagnostic Ultrasound Indications for Use Form
Voluson S6 / Voluson S8 / Voluson S10 Ultrasound System
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application
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 | 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 | [5] |
| Cardiac[3] | P | P | P | P | P | P | P | P | P | P | [5] |
| Peripheral Vascular | P | P | P | | P | P | P | P | P | P | [5,6,9] |
| Musculo-skeletal Conventional | P | P | P | | P | P | P | P | P | P | [5,6,9] |
| Musculo-skeletal Superficial | 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 | [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
[1] Abdominal includes renal, GYN/Pelvic Notes:
[2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients
[3] Cardiac is Adult and Pediatric
[5] 3D/4D Imaging Mode
[6] Includes imaging of guidance of biopsy (2D/3D/4D)
[7] Includes infertility monitoring of follicle development
[8] Includes urology/prostate
[9] Elastography imaging- Elasticity
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/PWD
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
5
Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' written in a stylized, cursive font, enclosed within a circular shape. The circle has a decorative, swirling pattern around the letters, and the entire logo is colored in a shade of blue.
Diagnostic Ultrasound Indications for Use Form
Voluson S6 / Voluson S8 / Voluson S10 with IC9-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | ||||||||||||
| 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] | N | N | N | N | N | N | N | N | N | N | [ 6,9] | |
| Abdominal[1] | N | N | N | N | N | N | N | N | N | N | [ 6,9] | |
| 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] | N | N | N | N | N | N | N | N | N | N | [ 6,9] | |
| Transvaginal[10] | N | N | N | N | N | N | N | N | N | N | [ 6,9] | |
| Transuretheral | ||||||||||||
| Intraoperative | ||||||||||||
| Intraoperative Neurological | ||||||||||||
| Intravascular | ||||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA
[1] Abdominal includes renal, GYN/Pelvic Notes:
- [2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients
- [3] Cardiac is Adult and Pediatric
- [5] 3D/4D Imaging Mode
- [6] Includes imaging of guidance of biopsy (2D/3D/4D)
- [7] Includes infertility monitoring of follicle development
- [8] Includes urology/prostate
- [9] Elastography imaging- Elasticity
- [*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/PWD
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
6
Image /page/6/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' written in a stylized, cursive font, enclosed within a circular shape. The circle has a decorative, swirling pattern around the letters, and the entire logo is colored in a shade of blue.
Diagnostic Ultrasound Indications for Use Form
Voluson S6 / Voluson S8 / Voluson S10 with 4C-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | |||||||||||
| 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 | [6] | |
| Abdominal[1] | P | P | P | P | P | P | P | P | P | [6] | |
| Pediatric | P | P | P | P | P | P | P | P | P | [6] | |
| Small Organ[2] | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac[3] | |||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | [6] | |
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | P | P | [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
Notes: [1] Abdominal includes renal, GYN/Pelvic
[2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients
[3] Cardiac is Adult and Pediatric.
[5] 3D/4D Imaging Mode.
[6] Includes imaging of guidance of biopsy (2D/3D/4D).
[7] Includes infertility monitoring of follicle development.
[8] Includes urology/prostate.
[9] Elastography imaging- Elasticity
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/PWD
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
7
Image /page/7/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a circular shape. The circle has a swirling pattern around the letters, giving it a dynamic and recognizable appearance. The color of the logo is a light blue.
Diagnostic Ultrasound Indications for Use Form
Voluson S6 / Voluson S8 / Voluson S10 with C1-5-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | |||||||||||
| 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 | [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[8] | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Intraoperative | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular | |||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA
Notes: [1] Abdominal includes renal, GYN/Pelvic
[2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients
[3] Cardiac is Adult and Pediatric.
[5] 3D/4D Imaging Mode.
[6] Includes imaging of guidance of biopsy (2D/3D/4D).
[7] Includes infertility monitoring of follicle development.
[8] Includes urology/prostate.
[9] Elastography imaging- Elasticity
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/PWD
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
8
Image /page/8/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font in the center. There are three swirls around the outside of the circle. The logo is simple and recognizable.
Diagnostic Ultrasound Indications for Use Form
Voluson S6 / Voluson S8 / Voluson S10 with 8C-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | ||||||||||||
| 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 | |||
| Abdominal[1] | P | P | P | P | P | P | P | P | P | |||
| Pediatric | P | P | P | P | P | P | P | P | P | |||
| Small Organ[2] | P | P | P | P | P | P | P | P | P | |||
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | |||
| Adult Cephalic | ||||||||||||
| Cardiac[3] | P | P | P | P | P | P | P | P | P | |||
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | |||
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | P | P | |||
| Musculo-skeletal Superficial | P | P | P | P | P | P | P | P | P | |||
| Other | ||||||||||||
| Exam Type, Means of Access | ||||||||||||
| Transesophageal | ||||||||||||
| Transrectal[8] | ||||||||||||
| Transvaginal | ||||||||||||
| Transuretheral | ||||||||||||
| Intraoperative | ||||||||||||
| Intraoperative Neurological | ||||||||||||
| Intravascular | ||||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA
Notes: [1] Abdominal includes renal, GYN/Pelvic
[2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients
[3] Cardiac is Adult and Pediatric.
[5] 3D/4D Imaging Mode.
[6] Includes imaging of guidance of biopsy (2D/3D/4D).
[7] Includes infertility monitoring of follicle development.
[8] Includes urology/prostate.
[9] Elastography imaging- Elasticity
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/PWD
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
9
Image /page/9/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' written in a stylized, cursive font, enclosed within a circular shape. The circle has a decorative, swirling pattern around the letters, and the entire logo is colored in a shade of blue.
Diagnostic Ultrasound Indications for Use Form
Voluson S6 / Voluson S8 / Voluson S10 with E8C-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | |||||||||||
| 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 | [6,9] | |
| Abdominal[1] | P | P | P | P | P | P | P | P | P | [6,9] | |
| Pediatric | |||||||||||
| Small Organ[2] | |||||||||||
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | [6,9] | |
| 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
Notes: [1] Abdominal includes renal, GYN/Pelvic
[2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients
[3] Cardiac is Adult and Pediatric
[5] 3D/4D Imaging Mode
[6] Includes imaging of guidance of biopsy (2D/3D/4D)
[7] Includes infertility monitoring of follicle development
[8] Includes urology/prostate
[9] Elastography imaging- Elasticity
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/PWD
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
10
Image /page/10/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a circular border. The letters and the border are in a blue color, while the background is white. The logo is simple, yet recognizable, and represents the brand identity of General Electric.
Diagnostic Ultrasound Indications for Use Form
Voluson S6 / Voluson S8 / Voluson S10 with with 12L-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | ||||||||||||
| 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] | ||||||||||||
| 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[8] | ||||||||||||
| Transvaginal | ||||||||||||
| Transuretheral | ||||||||||||
| Intraoperative | ||||||||||||
| Intraoperative Neurological | ||||||||||||
| Intravascular | ||||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA
Notes: [1] Abdominal includes renal, GYN/Pelvic
[2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients
[3] Cardiac is Adult and Pediatric.
[5] 3D/4D Imaging Mode.
[6] Includes imaging of guidance of biopsy (2D/3D/4D).
[7] Includes infertility monitoring of follicle development.
[8] Includes urology/prostate.
[9] Elastography imaging- Elasticity
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/PWD
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
11
Image /page/11/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' written in a stylized, cursive font, enclosed within a circular shape. The circle has a decorative, swirling pattern around the letters, and the entire logo is colored in a shade of blue.
Diagnostic Ultrasound Indications for Use Form
Voluson S6 / Voluson S8 / Voluson S10 with 9L-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | |||||||||||
| 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 | [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 | P | P | P | P | P | P | P | P | P | [6] | |
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | P | P | [6] | |
| Musculo-skeletal Superficial | P | P | P | P | P | P | P | P | P | [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
Notes: [1] Abdominal includes renal, GYN/Pelvic
[2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients
[3] Cardiac is Adult and Pediatric.
[5] 3D/4D Imaging Mode.
[6] Includes imaging of guidance of biopsy (2D/3D/4D).
[7] Includes infertility monitoring of follicle development.
[8] Includes urology/prostate.
[9] Elastography imaging- Elasticity
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/PWD
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
12
Image /page/12/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a circular shape. The circle has a swirling pattern around the letters, giving it a dynamic and recognizable appearance. The color of the logo is a light blue.
Diagnostic Ultrasound Indications for Use Form
Voluson S6 / Voluson S8 / Voluson S10 with 3Sc-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | |||||||||||
| 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 | P | [6] |
| Abdominal[1] | P | P | P | P | P | P | P | P | P | P | [6] |
| Pediatric | P | P | P | P | P | P | P | P | P | P | [6] |
| Small Organ[2] | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | P | P | P | P | P | P | P | P | P | P | [6] |
| 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[8] | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Intraoperative | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular | |||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA
Notes: [1] Abdominal includes renal, GYN/Pelvic
[2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients
[3] Cardiac is Adult and Pediatric.
[5] 3D/4D Imaging Mode.
[6] Includes imaging of guidance of biopsy (2D/3D/4D).
[7] Includes infertility monitoring of follicle development.
[8] Includes urology/prostate.
[9] Elastography imaging- Elasticity
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/PWD
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
13
Image /page/13/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a blue circle. The letters are white, creating a contrast against the blue background.
Diagnostic Ultrasound Indications for Use Form
Voluson S6 / Voluson S8 / Voluson S10 with RIC5-9A-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | |||||||||||
| 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] | N | N | N | N | N | N | N | N | N | [ 5,6,9] | |
| Abdominal[1] | N | N | N | N | N | N | N | N | N | [ 5,6,9] | |
| 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] | N | N | N | N | N | N | N | N | N | [ 5,6,9] | |
| Transvaginal | N | N | N | N | N | N | N | N | N | [ 5,6,9] | |
| Transuretheral | |||||||||||
| Intraoperative | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular | |||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA
Notes: [1] Abdominal includes renal, GYN/Pelvic
[2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients
[3] Cardiac is Adult and Pediatric.
[5] 3D/4D Imaging Mode.
[6] Includes imaging of guidance of biopsy (2D/3D/4D).
[7] Includes infertility monitoring of follicle development.
[8] Includes urology/prostate.
[9] Elastography imaging- Elasticity
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/PWD
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
14
Image /page/14/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' written in a stylized, cursive font, enclosed within a circular shape. The circle has a decorative, swirling pattern around the letters, and the entire logo is colored in a shade of blue.
Diagnostic Ultrasound Indications for Use Form
Voluson S6 / Voluson S8 / Voluson S10 with RAB6-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | ||||||||||||
| 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[8] | ||||||||||||
| Transvaginal | ||||||||||||
| Transuretheral | ||||||||||||
| Intraoperative | ||||||||||||
| Intraoperative Neurological | ||||||||||||
| Intravascular | ||||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA
Notes: [1] Abdominal includes renal, GYN/Pelvic
[2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients
[3] Cardiac is Adult and Pediatric.
[5] 3D/4D Imaging Mode.
[6] Includes imaging of guidance of biopsy (2D/3D/4D).
[7] Includes infertility monitoring of follicle development.
[8] Includes urology/prostate.
[9] Elastography imaging- Elasticity
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/PWD
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
15
Image /page/15/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in white inside. The letters are stylized and connected, and there are decorative swirls around the letters. The blue circle has a white border.
Diagnostic Ultrasound Indications for Use Form
Voluson S8 / Voluson S10 with ML6-15-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | ||||||||||||
| 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] | ||||||||||||
| Abdominal[1] | P | P | P | P | P | P | P | P | P | [6,9] | ||
| 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[8] | ||||||||||||
| Transvaginal | ||||||||||||
| Transuretheral | ||||||||||||
| Intraoperative | ||||||||||||
| Intraoperative Neurological | ||||||||||||
| Intravascular | ||||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA
[1] Abdominal includes renal, GYN/Pelvic Notes:
[2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients
[3] Cardiac is Adult and Pediatric.
[5] 3D/4D Imaging Mode.
[6] Includes imaging of guidance of biopsy (2D/3D/4D).
[7] Includes infertility monitoring of follicle development.
[8] Includes urology/prostate.
[9] Elastography imaging- Elasticity
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/PWD
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
16
Image /page/16/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a circular border. The color of the logo is a light blue.
Diagnostic Ultrasound Indications for Use Form
Voluson S8 / Voluson S10 with 12S-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application
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] | | | | | | | | | | | | |
| Abdominal[1] | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | P | P | P | | |
| Small Organ[2] | P | P | P | P | P | P | P | P | P | P | P | |
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | P | P | |
| Adult Cephalic | P | P | P | P | P | P | P | P | P | P | P | |
| Cardiac[3] | P | P | P | P | P | P | P | P | P | P | P | |
| Peripheral Vascular | | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | | |
| 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
[1] Abdominal includes renal, GYN/Pelvic Notes:
[2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients
[3] Cardiac is Adult and Pediatric.
[5] 3D/4D Imaging Mode.
[6] Includes imaging of guidance of biopsy (2D/3D/4D).
[7] Includes infertility monitoring of follicle development.
[8] Includes urology/prostate.
[9] Elastography imaging- Elasticity
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/PWD
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
17
Image /page/17/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a blue circle. Three curved, wave-like shapes surround the circle, adding a dynamic element to the design. The logo is simple, recognizable, and represents the multinational conglomerate corporation.
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | January 20, 2016 |
|---|---|
| Submitter: | GE Healthcare |
| 9900 Innovation Dr | |
| Wauwatosa, WI 53226 | |
| Primary Contact Person: | Tracey Ortiz |
| Regulatory Affairs Director | |
| GE Healthcare | |
| T:(262)676-6120 | |
| F:(414)918-8275 | |
| Secondary Contact Person: | Chan Sook Kim |
| Regulatory Affairs Leader | |
| GE Healthcare | |
| T: +82 31 740 6307 | |
| F: +82 31 740 6431 | |
| Device: Trade Name: | Voluson S6 / Voluson S8 / Voluson S10 |
| Common/Usual Name: | Ultrasound system |
| Classification Names: | Class II |
| Product Code: | Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-IYN |
| Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO | |
| Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX | |
| Predicate Device(s): | K141639 Voluson S Series; Voluson S6/S8 Diagnostic |
| Ultrasound System | |
| K152567 Voluson E Series; E6/E8/E10 Diagnostic Ultrasound | |
| System | |
| K142472 Voluson E Series; E6/E8/E10 Diagnostic Ultrasound | |
| System | |
| Device Description: | The systems are full-featured Track 3 ultrasound systems |
| primarily for general radiology use and specialized for OB/GYN | |
| with particular features for realtime 3D/4D acquisition. They | |
| consist of a mobile console with keyboard control panel; color | |
| LCD/TFT touch panel, color video display and optional image | |
| storage and printing devices. They provide high performance | |
| ultrasound imaging and analysis and have comprehensive | |
| networking and DICOM capability. They utilize a variety of | |
| linear, curved linear, matrix phased array transducers including |
18
Image /page/18/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" in a stylized font, enclosed within a blue circle. There are decorative white swirls surrounding the circle, adding a touch of elegance to the design.
mechanical and electronic scanning transducers, which provide accurate realtime three dimensional imaging supporting all standard acquisition modes.
The device is a general purpose ultrasound system. Intended Use: Specific clinical applications remain the same as previously cleared: Fetal/OB; Abdominal (including renal and GYN/pelvic); Pediatric; Small Organ (breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transrectal (TR); Transvaginal (TV).
The Voluson S6 / Voluson S8 / Voluson S10 employs the same Technology: fundamental scientific technology as its predicate devices.
Determination of Comparison to Predicates
Substantial Equivalence: The Voluson S6 / Voluson S8 / Voluson S10 is substantially equivalent to the predicate devices with regards to intended use, imaging capabilities, technologicial characteristics and safety and effectiveness.
- The systems are all intended for diagnostic ultrasound imaging and fluid flow analysis.
- . The Voluson S6/S8/S10 and predicate Voluson S6/S8 systems have the same clinical intended use.
- o The Voluson S6/S8/S10 and predicate Voluson S6/S8 systems have the same imaging modes.
- The Voluson S6/S8/S10 and predicate Voluson S6/S8 systems transducers are identical except for the removal of six transducers (RAB4-8-RS, RIC5-9W-RS, P2D, RAB2-5-RS. AB2-7-RS. RAB2-6-RS): the removal of ML6-15-RS and the 12S-RS probes on Voluson S6; the addition of two new transducers IC9-RS (similar to IC9-D on predicate Voluson E Series K152567), and RIC5-9A-RS (similar to RIC5-9W-RS on predicate Voluson S Series K141639)
- The Voluson S6/S8/S10 and predicate Voluson S6/S8 systems have the same indications for use.
- The systems are manufactured with materials which have been evaluated and found to be safe for the intended use
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of the device.
- The systems have acoustic power levels which are below ● the applicable FDA limits.
- The Voluson S6/S8/S10 and predicate Voluson S6/S8 o systems have similar capability in terms of performing measurements, capturing digital images, reviewing and reporting studies.
- o The Voluson S6/S8/S10 and predicate systems have been designed in compliance with approved electrical and physical safety standards.
- The Voluson S6/S8/S10 adds a SIM card to the system to allow users to send images and text via MMS SMS wirelessly. (previously cleared with K142472).
- The Voluson S6/S8/S10 adds a GYN measurement tool created by IOTA Group called IOTA LR2 model (previously cleared with K142472).
- The proposed Voluson S6/S8/S10 adds software features ● called SonoAVC antral and SonoAVC general. (previously cleared with K152567).
- The proposed Voluson S6/S8/S10 beam former has changed to STB MLA4 previously cleared with K152567 / K142472.
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 to applicable medical device safety standards. The Voluson S6/S8/S10 systems and its applications comply with voluntary standards:
- AAMI/ANSI ES60601-1, Medical Electrical Equipment -Part 1: General Requirements for Safety
- IEC60601-1-2, Medical Electrical Equipment -● Part 1-2:General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility Requirements and Tests
- IEC60601-2-37. Medical Electrical Equipment -Part 2-37:Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment
- NEMA UD 3, Standard for Real Time Display of Thermal ●
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GE Healthcare
510(k) Premarket Notification Submission
and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- ISO10993-1, Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing
- NEMA UD 2, Acoustic Output Measurement Standard for ● Diagnostic Ultrasound Equipment
- ISO14971, Application of risk management to medical ● devices
- NEMA, Digital Imaging and Communications in ● Medicine (DICOM) Set. (Radiology)
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) ●
- Performance testing (Verification)
- Safety testing (Verification) o
Transducer materials and other patient contact materials are biocompatible.
Summary of Clinical Tests:
The subject of this premarket submission, Voluson S6 / Voluson S8 / Voluson S10, did not require clinical studies to support substantial equivalence.
- GE Healthcare considers the Voluson S6 / Voluson S8 / Voluson Conclusion: S10 to be as safe, as effective, and performance is substantially equivalent to the predicate device(s).