(82 days)
Not Found
No
The document does not mention AI, ML, or related terms, and the description focuses on standard ultrasound system components and capabilities.
No.
The device is a diagnostic ultrasound system and is described as providing "digital acquisition, processing, analysis and display capability" for imaging, indicating a diagnostic rather than therapeutic purpose.
Yes
The Device Description explicitly states that "Vivid S60N / Vivid S70N is a Track 3 diagnostic ultrasound system" and "It is a full featured diagnostic ultrasound system".
No
The device description explicitly states it is a "full featured diagnostic ultrasound system" consisting of a mobile console, control panel, displays, and various electronic array transducers, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Vivid S60N/Vivid S70N is an ultrasound system. It uses sound waves to create images of internal body structures. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly describes imaging and analysis of various anatomical sites within the body, not the analysis of biological samples.
Therefore, the Vivid S60N/Vivid S70N falls under the category of a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Vivid S60N/Vivid S70N is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified physician for ultrasound imaging and analysis for the following applications: Fetal/Obstetrics; Abdominal (Including Renal & Gyn); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Cadiac (adult and pediatric); Peripheral Vasculo-sketal Conventional; Musculo-skeletal Superficial; Urology (including prostate); Transesophageal; Transvaginal; Transrectal; Intra-cardiac and Intra-luminal.
Product codes (comma separated list FDA assigned to the subject device)
IYN, ITX, IYO
Device Description
Vivid S60N / Vivid S70N is a Track 3 diagnostic ultrasound system, which is primarily intended for cardiac imaging and analysis but also includes vascular and general radiology applications. It is a full featured diagnostic ultrasound system that provides digital acquisition, processing, analysis and display capability.
The Vivid S60N / Vivid S70N consists of a mobile console with a height-adjustable control panel, color LCD touch panel, LCD display monitor and optional image storage and printing devices. It includes a variety of electronic array transducers operating in linear, curved, sector/phased array, matrix array or dual array format, including dedicated CW transducers and real time 3D transducer.
The system includes electronics for transmit and receive of ultrasound data, ultrasound signal processing, software computing, hardware for Image storage, hard copy printing, and network access to the facility through both LAN and wireless (supported by use of a wireless LAN USB-adapter) connection.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal/Obstetrics; Abdominal (Including Renal & Gyn); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional: Musculo-skeletal Superficial: Urology (including prostate); Transesophageal; Transvaginal; Transrectal; Intra-cardiac and Intra-luminal.
Indicated Patient Age Range
Adult and pediatric (for cardiac applications), Fetal, Neonatal, Pediatric, no specific age range for most other applications.
Intended User / Care Setting
qualified physician / 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, Vivid S60N / Vivid S70N, 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.
Vivid S60, Vivid S70 (K142323), Vivid E80, Vivid E90, Vivid E95 (K150087), Vivid iq (K161706), LOGIQ E9 (K163077), TomTec Arena TTA2 (K150122)
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 U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS LLC June 14, 2017 TRACEY ORTIZ REGULATORY AFFAIRS DIRECTOR 9900 W. INNOVATION DRIVE WAUWATOSA, WI 53226
Re: K170878
Trade/Device Name: Vivid S60N. Vivid S70N Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, ITX, IYO Dated: May 15, 2017 Received: May 16, 2017
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.
Michael D. O'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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name Vivid S60N, Vivid S70N
Indications for Use (Describe)
Vivid S60N/Vivid S70N is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified physician for ultrasound imaging and analysis for the following applications: Fetal/Obstetrios; Abdominal (Including Renal & Gyn); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Cadiac (adult and pediatric); Peripheral Vasculo-sketal Conventional; Musculo-skeletal Superficial; Urology (including prostate); Transesophageal; Transvaginal; Transrectal; Intra-cardiac and Intra-luminal.
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)
3
Image /page/3/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined in a stylized script, enclosed within a circular border. The color of the logo is a light blue.
Indications for Use Forms
The following forms represent indications with clinical applications and exam types along with the modes of operation for the Vivid S60N / Vivid S70N. Combinations identified "P" represents those previously cleared with another GE Ultrasound system. Combinations identified as "N" are new.
The following Indication for Use forms are appended:
Transducer: 3Sc-RS Transducer: M5Sc-D Transducer: 6S-D Transducer: 12S-D Transducer: 9L-D Transducer: 11L-D Transducer: C1-6-D Transducer: C2-9-D
System: Vivid S60N / Vivid S70N
- Transducer: C3-10-D
- Transducer: iC5-9-D
- Transducer: 6VT-D
- Transducer: 6Tc-RS
- Transducer: 9T-RS
- Transducer: P2D
- Transducer: P6D
- Transducer: AcuNav 10F (G version)
- Transducer: AcuNav 8F (G version)
- Transducer: SOUNDSTAR 3D 10F (G version)
- Transducer: SOUNDSTAR eco 8F (G version)
- Transducer: SOUNDSTAR eco 10F (G version)
4
Image /page/4/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 four small white teardrop shapes around the letters. The logo is simple and recognizable, and it is associated with a well-known company.
Diagnostic Ultrasound Indications for Use Form GE Vivid S60N / Vivid S70N Ultrasound System
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 | N | N | N | N | N | N | N | N | N | N | [8,9] | |
| Fetal / Obstetrics | N | N | N | N | N | N | N | N | N | N | [8,9,1,2] | |
| Abdominal | N | N | N | N | N | N | N | N | N | N | [8,9] | |
| Pediatric | N | N | N | N | N | N | N | N | N | N | [8,9] | |
| Small Organ | N | N | N | N | N | N | N | N | N | N | [3,8] | |
| Neonatal Cephalic | N | N | N | N | N | N | N | N | N | N | [8,9] | |
| Adult Cephalic | N | N | N | N | N | N | N | N | N | N | [,9] | |
| Cardiac | N | N | N | N | N | N | N | N | N | N | [4,6,9] | |
| Peripheral Vascular | N | N | N | N | N | N | N | N | N | N | [8,9] | |
| Musculo-skeletal Conventional | N | N | N | N | N | N | N | N | N | N | [8] | |
| Musculo-skeletal Superficial | N | N | N | N | N | N | N | N | N | N | [8] | |
| Other | N | N | N | N | N | N | N | N | N | N | [5,8,9] | |
| Exam Type, Means of Access | ||||||||||||
| Transesophageal | N | N | N | N | N | N | N | N | N | N | [6,9] | |
| Transrectal | N | N | N | N | N | N | N | N | N | N | [8] | |
| Transvaginal | N | N | N | N | N | N | N | N | N | N | [8] | |
| Transuretheral | N | N | N | N | N | N | N | N | N | N | ||
| Intraoperative | N | N | N | N | N | N | N | N | N | N | ||
| Intraoperative Neurological | N | N | N | N | N | N | N | N | N | N | ||
| Intravascular | N | N | N | N | N | N | N | N | N | N | ||
| Interventional Guidance | N | N | N | N | N | N | N | N | N | N | ||
| Intracardiac and Intraluminal | N | N | N | N | N | N | N | N | N | N | [9] | |
| Tissue Biopsy | N | N | N | N | N | N | N | N | N | N | [7,8,9] | |
| Vascular Access (IV, PICC) | N | N | N | N | N | N | N | N | N | N | [8] |
P = previously cleared by FDA on Vivid S60 (K142323); P1 = previously cleared by FDA on LOGIQ E9 (K163077); P2 = previously cleared by FDA on Vivid E90/Vivid E95 (K150087); P3 = previously cleared by FDA on Vivid iq
(K161706); N = New indication.
Notes: Abdominal includes renal, GYN/Pelvic [1]
[2] Abdominal includes Aorto-Iliac Artery
[3] Small organ includes breast, testes, thyroid.
[4] Cardiac is Adult and Pediatric.
Other use includes Urology/Prostate 151
[6] 3D/4D Imaging mode
[7] Includes image guidance for freehand needle placement
Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8]
Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD 191
System provides real-time 3D and 4D acquisition when used with special 4D probes.
(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
Diagnostic Ultrasound Indications for Use Form GE Vivid S60N / Vivid S70N with C3-10-D 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 | |||||||||||
| Abdominal | N | N | N | N | N | N | N | N | N | [8,1] | |
| Pediatric | P1 | P1 | P1 | P1 | N | P1 | P1 | P1 | P1 | [8] | |
| Small Organ | |||||||||||
| Neonatal Cephalic | P1 | bl | P1 | b1 | N | ь1 | ь1 | P1 | P1 | [8] | |
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Peripheral Vascular | P1 | P1 | P1 | P1 | N | P1 | P1 | P1 | P1 | [8] | |
| Musculo-skeletal Conventional | N | N | N | N | N | N | N | N | N | [8] | |
| Musculo-skeletal Superficial | P1 | P1 | P1 | P1 | N | P1 | P1 | P1 | P1 | [8] | |
| Other | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Intraoperative | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular | |||||||||||
| Interventional Guidance | |||||||||||
| Intracardiac and Intraluminal | |||||||||||
| Tissue Biopsy | P1 | ь1 | P1 | ь1 | N | ь1 | b1 | N | N | [7,8] | |
| Vascular Access (IV, PICC) | P1 | P1 | P1 | P1 | N | P1 | P1 | N | N | [8] |
P = previously cleared by FDA on Vivid S60 (K142323); P1 = previously cleared by FDA on LOGIQ E9 (K163077); P2 = previously cleared by FDA on Vivid E90/Vivid E95 (K150087); P3 = previously cleared by FDA on Vivid iq (K161706); N = New indication.
Notes: Abdominal includes renal. GYN/Pelvic [1]
Abdominal includes Aorto-Iliac Artery [2]
- [3] Small organ includes breast, testes, thyroid.
Cardiac is Adult and Pediatric. [4]
Other use includes Urology/Prostate ાં છે.
[6] 3D/4D Imaging mode
[7] Includes image guidance for freehand needle placement
Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8]
Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD [9]
System provides real-time 3D and 4D acquisition when used with special 4D probes.
(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 script, enclosed within a blue circle. The circle has decorative swirls or flourishes around the letters, giving it a classic and recognizable appearance. The logo is simple, yet distinctive, and is widely recognized as the symbol of the General Electric company.
Diagnostic Ultrasound Indications for Use Form GE Vivid S60N / Vivid S70N with 12S-D 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 | |||||||||||
| Abdominal | P | P | P | P | P | P | P | P | P | P | [9,1] |
| Pediatric | P | P | P | P | P | P | P | P | P | P | [9] |
| Small Organ | |||||||||||
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | P | [9] |
| Adult Cephalic | |||||||||||
| Cardiac | P | P | P | P | P | P | P | P | P | P | [4,9] |
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | P | [9] |
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular | |||||||||||
| Interventional Guidance | |||||||||||
| Intracardiac and Intraluminal | |||||||||||
| Tissue Biopsy | |||||||||||
| Vascular Access (IV, PICC) |
P = previously cleared by FDA on Vivid S60 (K142323); P1 = previously cleared by FDA on LOGIQ E9 (K163077); P2 = previously cleared by FDA on Vivid E90/Vivid E95 (K150087); P3 = previously cleared by FDA on Vivid iq (K161706); N = New indication.
[1] Abdominal includes renal, GYN/Pelvic Notes:
[2] Abdominal includes Aorto-Iliac Artery
[3] Small organ includes breast, testes, thyroid.
[4] Cardiac is Adult and Pediatric.
Other use includes Urology/Prostate ાં છે.
[6] 3D/4D Imaging mode
[7] Includes image guidance for freehand needle placement
Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8]
Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD [9]
System provides real-time 3D and 4D acquisition when used with special 4D probes.
(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 border. There are four small, stylized flourishes or embellishments evenly spaced around the outside of the circle. The logo is rendered in a blue color.
Diagnostic Ultrasound Indications for Use Form GE Vivid S60N / Vivid S70N 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 | ||||||||||||
| 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 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | [8] | ||
| Abdominal | ||||||||||||
| Pediatric | ||||||||||||
| Small Organ (specify) | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Cardiac | ||||||||||||
| Peripheral Vascular | ||||||||||||
| Musculo-skeletal Conventional | ||||||||||||
| Musculo-skeletal Superficial | ||||||||||||
| Other | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | [5,8] | ||
| Exam Type, Means of Access | ||||||||||||
| Transesophageal | ||||||||||||
| Transrectal | P2 | P2 | P2 | P2 | P2 | P2 | P2 | N | P2 | [8] | ||
| Transvaginal | P2 | P2 | P2 | P2 | P2 | P2 | P2 | N | P2 | [8] | ||
| Transuretheral | ||||||||||||
| Intraoperative (specify) | ||||||||||||
| Intraoperative Neurological | ||||||||||||
| Intravascular | ||||||||||||
| Interventional Guidance | ||||||||||||
| Intracardiac and Intraluminal | ||||||||||||
| Tissue Biopsy | P2 | P2 | P2 | P2 | P2 | P2 | P2 | N | P2 | [7,8] | ||
| Vascular Access (IV, PICC) | P2 | P2 | P2 | P2 | P2 | P2 | P2 | N | P2 | [8] |
P = previously cleared by FDA on Vivid S60 (K142323); P1 = previously cleared by FDA on LOGIQ E9 (K163077); P2 = previously cleared by FDA on Vivid E90/Vivid E95 (K150087); P3 = previously cleared by FDA on Vivid ig (K161706); N = New indication.
Notes: [1] Abdominal includes renal, GYN/Pelvic
Abdominal includes Aorto-Iliac Artery (2
- [3] Small organ includes breast, testes, thyroid.
Cardiac is Adult and Pediatric. [4]
[5] Other use includes Urology/Prostate
3D/4D Imaging mode [6]
[7] Includes image guidance for freehand needle placement
Combined modes are: B/M. B/Color M. B/PWD. B/Color/PWD. B/Power/PWD 181
Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD 191
System provides real-time 3D and 4D acquisition when used with special 4D probes.
(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 General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a blue circle. The circle has decorative swirls around its perimeter, giving it a classic and recognizable appearance.
Diagnostic Ultrasound Indications for Use Form
GE Vivid S60N / Vivid S70N with C2-9-D 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 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | [8] |
| Abdominal | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | [1,8,2] |
| Pediatric | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | [8] |
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Peripheral Vascular | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | [8] |
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | [5,8] |
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular | |||||||||||
| Interventional Guidance | |||||||||||
| Intracardiac and Intraluminal | |||||||||||
| Tissue Biopsy | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | [7,8] |
| Vascular Access (IV, PICC) | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | [8] |
P = previously cleared by FDA on Vivid S60 (K142323); P1 = previously cleared by FDA on LOGIQ E9 (K163077); P2 = previously cleared by FDA on Vivid E90/Vivid E95 (K150087); P3 = previously cleared by FDA on Vivid iq (K161706); N = New indication.
Abdominal includes renal, GYN/Pelvic Notes: [1]
[2] Abdominal includes Aorto-Iliac Artery
-
[3] Small organ includes breast, testes, thyroid.
[4] Cardiac is Adult and Pediatric. -
Other use includes Urology/Prostate [5]
-
3D/4D Imaging mode 161
-
[7] Includes image quidance for freehand needle placement
-
[8] Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD
-
Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD ાં છો
System provides real-time 3D and 4D acquisition when used with special 4D probes.
(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 blue circle. The circle is decorated with small, stylized floral or leaf-like shapes around its perimeter, giving it a distinctive and recognizable appearance.
Diagnostic Ultrasound Indications for Use Form GE Vivid S60N / Vivid S70N with 9L-D 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 | |||||||||||
| Abdominal | P1 | P1 | P1 | P1 | P1 | P1 | P1 | P1 | P1 | P1 | [8,1] |
| Pediatric | P | P | P | P | P | P | P | P | P | P | [8] |
| Small Organ | P | P | P | P | P | P | P | P | P | P | [3,8] |
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | P | [8] |
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | P | P | P | [8] |
| Musculo-skeletal Superficial | N | N | N | N | N | N | N | N | N | N | [8] |
| Other | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular | |||||||||||
| Interventional Guidance | |||||||||||
| Intracardiac and Intraluminal | |||||||||||
| Tissue Biopsy | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | [7,8] |
| Vascular Access (IV, PICC) | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | [8] |
P = previously cleared by FDA on Vivid S60 (K142323); P1 = previously cleared by FDA on LOGIQ E9 (K163077); P2 = previously cleared by FDA on Vivid E90/Vivid E95 (K150087); P3 = previously cleared by FDA on Vivid iq (K161706); N = New indication.
Notes: Abdominal includes renal. GYN/Pelvic [1]
Abdominal includes Aorto-Iliac Artery [2]
- Small organ includes breast, testes, thyroid. [3]
Cardiac is Adult and Pediatric. [4]
Other use includes Urology/Prostate ાં છે.
[6] 3D/4D Imaging mode
[7] Includes image guidance for freehand needle placement
[8] Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD
Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD [a]
System provides real-time 3D and 4D acquisition when used with special 4D probes.
(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" written in a stylized, cursive font, enclosed within a blue circle. The circle is decorated with small, stylized floral or leaf-like shapes around its perimeter, giving it a distinctive and recognizable appearance.
Diagnostic Ultrasound Indications for Use Form GE Vivid S60N / Vivid S70N with 11L-D 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 | ||||||||||||
| Abdominal | ||||||||||||
| Pediatric | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | [8] | |
| Small Organ | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | [3,8] | |
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Cardiac | ||||||||||||
| Peripheral Vascular | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | [8] | |
| Musculo-skeletal Conventional | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | [8] | |
| Musculo-skeletal Superficial | N | N | N | N | N | N | N | N | N | N | [8] | |
| Other | ||||||||||||
| Exam Type, Means of Access | ||||||||||||
| Transesophageal | ||||||||||||
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Transuretheral | ||||||||||||
| Intraoperative | ||||||||||||
| Intraoperative Neurological | ||||||||||||
| Intravascular | ||||||||||||
| Interventional Guidance | ||||||||||||
| Intracardiac and Intraluminal | ||||||||||||
| Tissue Biopsy | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | [7,8] | |
| Vascular Access (IV, PICC) | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | [8] |
P = previously cleared by FDA on Vivid S60 (K142323); P1 = previously cleared by FDA on LOGIQ E9 (K163077); P2 = previously cleared by FDA on Vivid E90/Vivid E95 (K150087); P3 = previously cleared by FDA on Vivid iq (K161706); N = New indication.
Notes: Abdominal includes renal. GYN/Pelvic [1]
Abdominal includes Aorto-Iliac Artery [2]
- Small organ includes breast, testes, thyroid. [3]
Cardiac is Adult and Pediatric. [4]
Other use includes Urology/Prostate ાં છે.
[6] 3D/4D Imaging mode
[7] Includes image guidance for freehand needle placement
[8] Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD
Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD [a]
System provides real-time 3D and 4D acquisition when used with special 4D probes.
(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 is a blue circle with the letters "GE" in a stylized script inside. The circle has a decorative border with four teardrop-shaped elements around the perimeter. The logo is simple and recognizable, representing the well-known multinational corporation.
Diagnostic Ultrasound Indications for Use Form GE Vivid S60N / Vivid S70N with M5Sc-D 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 | P | P | P | P | P | P | P | P | P | P | [9] |
| Abdominal | P | P | P | P | P | P | P | P | P | P | [1,2,9] |
| Pediatric | P | P | P | P | P | P | P | P | P | P | [9] |
| Small Organ | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | P | P | P | P | P | P | P | P | P | P | [9] |
| Cardiac | P | P | P | P | P | P | P | P | P | P | [4,9] |
| Peripheral Vascular | N | N | N | N | N | N | N | N | N | N | [9] |
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other | P | P | P | P | P | P | P | P | P | P | [5,9] |
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular | |||||||||||
| Interventional Guidance | |||||||||||
| Intracardiac and Intraluminal | |||||||||||
| Tissue Biopsy | P | P | P | P | P | P | P | P | P | P | [9] |
| Vascular Access (IV, PICC) |
P = previously cleared by FDA on Vivid S60 (K142323); P1 = previously cleared by FDA on LOGIQ E9 (K163077); P2 = previously cleared by FDA on Vivid E90/Vivid E95 (K150087); P3 = previously cleared by FDA on Vivid iq (K161706); N = New indication.
Notes: Abdominal includes renal. GYN/Pelvic [1]
Abdominal includes Aorto-Iliac Artery [2]
- Small organ includes breast, testes, thyroid. [3]
Cardiac is Adult and Pediatric. [4]
Other use includes Urology/Prostate ાં છે.
[6] 3D/4D Imaging mode
[7] Includes image guidance for freehand needle placement
[8] Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD
Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD [a]
System provides real-time 3D and 4D acquisition when used with special 4D probes.
(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 'G' and 'E' intertwined in a stylized script, enclosed within a circular border. The logo is colored in a shade of blue, and the background is white.
Diagnostic Ultrasound Indications for Use Form GE Vivid S60N / Vivid S70N 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 | Modes | Combined Harmonic | |||||||||
| Imaging | Coded | ||||||||||
| Pulse | Other | ||||||||||
| [Notes] | |||||||||||
| Ophthalmic | |||||||||||
| Fetal / Obstetrics | P3 | P3 | P3 | P3 | P3 | P3 | P3 | P3 | P3 | N | [9] |
| Abdominal | P3 | P3 | P3 | P3 | P3 | P3 | P3 | P3 | P3 | N | [1,2,9] |
| Pediatric | P3 | P3 | P3 | P3 | P3 | P3 | P3 | P3 | P3 | N | [9] |
| Small Organ | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | P3 | P3 | P3 | P3 | P3 | P3 | P3 | P3 | P3 | N | [a] |
| Cardiac | P3 | P3 | P3 | P3 | P3 | ьз | P3 | P3 | P3 | N | [4,9] |
| Peripheral Vascular | N | N | N | N | N | N | N | N | N | N | [a] |
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular | |||||||||||
| Interventional Guidance | |||||||||||
| Intracardiac and Intraluminal | |||||||||||
| Tissue Biopsy | P3 | P3 | N | P3 | N | P3 | P3 | P3 | P3 | N | [9] |
| Vascular Access (IV, PICC) |
P = previously cleared by FDA on Vivid S60 (K142323); P1 = previously cleared by FDA on LOGIQ E9 (K163077); P2 = previously cleared by FDA on Vivid E90/Vivid E95 (K150087); P3 = previously cleared by FDA on Vivid iq (K161706); N = New indication.
Notes: Abdominal includes renal, GYN/Pelvic [1]
Abdominal includes Aorto-Iliac Artery [2]
[3] Small organ includes breast, testes, thyroid.
Cardiac is Adult and Pediatric. [4]
Other use includes Urology/Prostate [5]
3D/4D Imaging mode [6]
[7] Includes image guidance for freehand needle placement
Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8]
Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD [a]
System provides real-time 3D and 4D acquisition when used with special 4D probes.
(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 General Electric (GE) logo. The logo consists of the letters "GE" written in a stylized, cursive font, enclosed within a blue circle. The circle is decorated with small, stylized floral or leaf-like shapes around its perimeter, giving it a distinctive and recognizable appearance.
Diagnostic Ultrasound Indications for Use Form GE Vivid S60N / Vivid S70N with 6S-D 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 | P | P | P | P | P | P | P | P | P | P | [9] |
| Abdominal | P | P | P | P | P | P | P | P | P | P | [1,9] |
| Pediatric | P | P | P | P | P | P | P | P | P | P | [9] |
| Small Organ | |||||||||||
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | P | [9] |
| Adult Cephalic | |||||||||||
| Cardiac | P | P | P | P | P | P | P | P | P | P | [4,9] |
| Peripheral Vascular | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular | |||||||||||
| Interventional Guidance | |||||||||||
| Intracardiac and Intraluminal | |||||||||||
| Tissue Biopsy | |||||||||||
| Vascular Access (IV, PICC) |
P = previously cleared by FDA on Vivid S60 (K142323); P1 = previously cleared by FDA on LOGIQ E9 (K163077); P2 = previously cleared by FDA on Vivid E90/Vivid E95 (K150087); P3 = previously cleared by FDA on Vivid iq (K161706;) N = New indication.
Notes: Abdominal includes renal. GYN/Pelvic [1]
Abdominal includes Aorto-Iliac Artery [2]
- Small organ includes breast, testes, thyroid. [3]
Cardiac is Adult and Pediatric. [4]
Other use includes Urology/Prostate ાં છે.
[6] 3D/4D Imaging mode
[7] Includes image guidance for freehand needle placement
[8] Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD
Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD [a]
System provides real-time 3D and 4D acquisition when used with special 4D probes.
(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 script, enclosed within a blue circle. The circle has decorative swirls or flourishes around the letters, giving it a classic and recognizable appearance. The logo is simple, yet distinctive, and is widely recognized as the symbol of the General Electric company.
Diagnostic Ultrasound Indications for Use Form GE Vivid S60N / Vivid S70N with C1-6-D 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 | P | P | P | P | P | P | P | P | P | P | [8] |
| Abdominal | P | P | P | P | P | P | P | P | P | P | [1, 2, 8] |
| Pediatric | P | P | P | P | P | P | P | P | P | P | [8] |
| Small Organ | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | P | [8] |
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other | P | P | P | P | P | P | P | P | P | P | [5,8] |
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular | |||||||||||
| Interventional Guidance | |||||||||||
| Intracardiac and Intraluminal | |||||||||||
| Tissue Biopsy | P | P | P | P | P | P | P | P | P | P | [7,8] |
| Vascular Access (IV, PICC) |
P = previously cleared by FDA on Vivid S60 (K142323); P1 = previously cleared by FDA on LOGIQ E9 (K163077); P2 = previously cleared by FDA on Vivid E90/Vivid E95 (K150087); P3 = previously cleared by FDA on Vivid iq (K161706); N = New indication.
Notes: Abdominal includes renal, GYN/Pelvic [1]
[2] Abdominal includes Aorto-Iliac Artery
- Small organ includes breast, testes, thyroid. [3]
[4] Cardiac is Adult and Pediatric.
Other use includes Urology/Prostate [5]
ાદા 3D/4D Imaging mode
|71 Includes imaqe quidance for freehand needle placement
181 Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD
[9] Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD
System provides real-time 3D and 4D acquisition when used with special 4D probes.
(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 General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a blue circle. There are small, white, curved shapes around the outer edge of the circle, giving it a slightly textured or decorative appearance. The logo is simple, recognizable, and commonly associated with the multinational conglomerate.
Diagnostic Ultrasound Indications for Use Form GE Vivid S60N / Vivid S70N with 6VT-D 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 | |||||||||||
| Abdominal | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | P | P | P | P | P | P | P | P | P | P | [6,9] |
| Peripheral Vascular | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other (specify) | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | P | P | P | P | P | P | P | P | P | P | [6,9] |
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular | |||||||||||
| Interventional Guidance | |||||||||||
| Intracardiac and Intraluminal | |||||||||||
| Tissue Biopsy | |||||||||||
| Vascular Access (IV, PICC) |
P = previously cleared by FDA on Vivid S60 (K142323); P1 = previously cleared by FDA on LOGIQ E9 (K163077); P2 = previously cleared by FDA on Vivid E90/Vivid E95 (K150087); P3 = previously cleared by FDA on Vivid ig (K161706); N = New indication.
Notes: [1] Abdominal includes renal, GYN/Pelvic
Abdominal includes Aorto-Iliac Artery (2
- [3] Small organ includes breast, testes, thyroid.
Cardiac is Adult and Pediatric. [4]
[5] Other use includes Urology/Prostate
3D/4D Imaging mode [6]
[7] Includes image guidance for freehand needle placement
Combined modes are: B/M. B/Color M. B/PWD. B/Color/PWD. B/Power/PWD 181
Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD ાં છો
System provides real-time 3D and 4D acquisition when used with special 4D probes.
(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 is a blue circle with the letters "GE" in a stylized script inside. The circle has a decorative border with four teardrop-shaped elements around the perimeter. The logo is simple and recognizable, representing the well-known multinational corporation.
Diagnostic Ultrasound Indications for Use Form GE Vivid S60N / Vivid S70N with 6Tc-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 | |||||||||||
| Abdominal | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | P | P | P | P | P | P | P | P | P | P | [9] |
| Peripheral Vascular | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other (specify) | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | P | P | P | P | P | P | P | P | P | P | [9] |
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular | |||||||||||
| Interventional Guidance | |||||||||||
| Intracardiac and Intraluminal | |||||||||||
| Tissue Biopsy | |||||||||||
| Vascular Access (IV, PICC) |
P = previously cleared by FDA on Vivid S60 (K142323); P1 = previously cleared by FDA on LOGIQ E9 (K163077); P2 = previously cleared by FDA on Vivid E90/Vivid E95 (K150087); P3 = previously cleared by FDA on Vivid iq (K161706); N = New indication.
Notes: Abdominal includes renal, GYN/Pelvic [1]
[2] Abdominal includes Aorto-Iliac Artery
Small organ includes breast, testes, thyroid. [3]
[4] Cardiac is Adult and Pediatric.
Other use includes Urology/Prostate 151
[6] 3D/4D Imaging mode
[7] Includes image guidance for freehand needle placement
Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8]
Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD 191
System provides real-time 3D and 4D acquisition when used with special 4D probes.
(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 is a blue circle with the letters "GE" in a stylized script inside. The circle has a decorative border with four teardrop-shaped elements around the perimeter. The logo is simple and recognizable, representing the well-known multinational corporation.
Diagnostic Ultrasound Indications for Use Form GE Vivid S60N / Vivid S70N with 9T-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 | |||||||||||
| Abdominal | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | [9, 4] |
| Peripheral Vascular | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other (specify) | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | [9] |
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular | |||||||||||
| Interventional Guidance | |||||||||||
| Intracardiac and Intraluminal | |||||||||||
| Tissue Biopsy | |||||||||||
| Vascular Access (IV, PICC) |
P = previously cleared by FDA on Vivid S60 (K142323); P1 = previously cleared by FDA on LOGIQ E9 (K163077); P2 = previously cleared by FDA on Vivid E90/Vivid E95 (K150087); P3 = previously cleared by FDA on Vivid iq (K161706); N = New indication.
Notes: Abdominal includes renal, GYN/Pelvic [1]
[2] Abdominal includes Aorto-Iliac Artery
- Small organ includes breast, testes, thyroid. [3]
[4] Cardiac is Adult and Pediatric.
Other use includes Urology/Prostate 151
[6] 3D/4D Imaging mode
[7] Includes image guidance for freehand needle placement
Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8]
Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD 191
System provides real-time 3D and 4D acquisition when used with special 4D probes.
(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)
18
Image /page/18/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 decorative elements resembling stylized leaves or flourishes placed around the circle. The logo is presented in a blue color.
Diagnostic Ultrasound Indications for Use Form GE Vivid S60N / Vivid S70N with P2D 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 | |||||||||||
| Abdominal | |||||||||||
| Pediatric | |||||||||||
| Small Organ | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | P2 | P | [4] | ||||||||
| Peripheral Vascular | P2 | P2 | |||||||||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular | |||||||||||
| Interventional Guidance | |||||||||||
| Intracardiac and Intraluminal | |||||||||||
| Tissue Biopsy | |||||||||||
| Vascular Access (IV. PICC) |
P = previously cleared by FDA on Vivid S60 (K142323); P1 = previously cleared by FDA on LOGIQ E9 (K163077); P2 = previously cleared by FDA on Vivid E90/Vivid E95 (K150087); P3 = previously cleared by FDA on Vivid iq (K161706); N = New indication.
Notes: Abdominal includes renal, GYN/Pelvic [1]
Abdominal includes Aorto-Iliac Artery [2]
- [3] Small organ includes breast, testes, thyroid.
Cardiac is Adult and Pediatric. [4]
Other use includes Urology/Prostate [5]
3D/4D Imaging mode [6]
[7] Includes image guidance for freehand needle placement
Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8]
Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD [a]
System provides real-time 3D and 4D acquisition when used with special 4D probes.
(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)
19
Image /page/19/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. The circle has decorative flourishes at the cardinal points (top, bottom, left, and right), giving it a classic and recognizable appearance.
Diagnostic Ultrasound Indications for Use Form GE Vivid S60N / Vivid S70N with P6D 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 | |||||||||||
| Abdominal | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | P2 | P2 | [4] | ||||||||
| Peripheral Vascular | P2 | P2 | |||||||||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other (specify) | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular | |||||||||||
| Interventional Guidance | |||||||||||
| Intracardiac and Intraluminal | |||||||||||
| Tissue Biopsy | |||||||||||
| Vascular Access (IV, PICC) |
P = previously cleared by FDA on Vivid S60 (K142323); P1 = previously cleared by FDA on LOGIQ E9 (K163077); P2 = previously cleared by FDA on Vivid E90/Vivid E95 (K150087); P3 = previously cleared by FDA on Vivid ig (K161706); N = New indication.
Notes: [1] Abdominal includes renal, GYN/Pelvic
Abdominal includes Aorto-Iliac Artery (2
-
[3] Small organ includes breast, testes, thyroid.
Cardiac is Adult and Pediatric. [4] -
[5] Other use includes Urology/Prostate
3D/4D Imaging mode [6]
[7] Includes image guidance for freehand needle placement
Combined modes are: B/M. B/Color M. B/PWD. B/Color/PWD. B/Power/PWD 181
Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD ાં છો
System provides real-time 3D and 4D acquisition when used with special 4D probes.
(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)
20
Image /page/20/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 also some white swirls around the letters. The logo is simple and recognizable.
Diagnostic Ultrasound Indications for Use Form GE Vivid S60N / Vivid S70N with AcuNav 10F (G version) 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 | |||||||||||
| Abdominal | |||||||||||
| Pediatric | |||||||||||
| Small Organ | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Peripheral Vascular | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular | |||||||||||
| Interventional Guidance | |||||||||||
| Intracardiac and Intraluminal | P3 | P3 | P3 | P3 | P3 | P3 | P3 | P3 | P3 | P3 | [9] |
| Tissue Biopsy | |||||||||||
| Vascular Access (IV. PICC) |
P = previously cleared by FDA on Vivid S60 (K142323); P1 = previously cleared by FDA on LOGIQ E9 (K163077); P2 = previously cleared by FDA on Vivid E90/Vivid E95 (K150087); P3 = previously cleared by FDA on Vivid iq (K161706); N = New indication.
Notes: Abdominal includes renal, GYN/Pelvic [1]
Abdominal includes Aorto-Iliac Artery [2]
- [3] Small organ includes breast, testes, thyroid.
Cardiac is Adult and Pediatric. [4]
Other use includes Urology/Prostate [5]
- 3D/4D Imaging mode [6]
[7] Includes image guidance for freehand needle placement
Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8]
Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD [a]
System provides real-time 3D and 4D acquisition when used with special 4D probes.
(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)
21
Image /page/21/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, rounded shapes at the four cardinal points around the circle.
Diagnostic Ultrasound Indications for Use Form GE Vivid S60N / Vivid S70N with AcuNav 8F (G version) 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 | |||||||||||
| Abdominal | |||||||||||
| Pediatric | |||||||||||
| Small Organ | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Peripheral Vascular | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular | |||||||||||
| Interventional Guidance | |||||||||||
| Intracardiac and Intraluminal | P3 | P3 | P3 | P3 | P3 | P3 | P3 | P3 | P3 | [9] | |
| Tissue Biopsy | |||||||||||
| Vascular Access (IV. PICC) |
P = previously cleared by FDA on Vivid S60 (K142323); P1 = previously cleared by FDA on LOGIQ E9 (K163077); P2 = previously cleared by FDA on Vivid E90/Vivid E95 (K150087); P3 = previously cleared by FDA on Vivid iq (K161706); N = New indication.
Notes: Abdominal includes renal, GYN/Pelvic [1]
Abdominal includes Aorto-Iliac Artery [2]
[3] Small organ includes breast, testes, thyroid.
Cardiac is Adult and Pediatric. [4]
Other use includes Urology/Prostate [5]
3D/4D Imaging mode [6]
[7] Includes image guidance for freehand needle placement
Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8]
Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD [a]
System provides real-time 3D and 4D acquisition when used with special 4D probes.
(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)
22
Image /page/22/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 script inside. There are small white flourishes around the edge of the circle. The blue color is a medium shade, and the overall design is simple and recognizable.
Diagnostic Ultrasound Indications for Use Form GE Vivid S60N / Vivid S70N with SOUNDSTAR 3D 10F (G version) 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 | |||||||||||
| Abdominal | |||||||||||
| Pediatric | |||||||||||
| Small Organ | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Peripheral Vascular | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular | |||||||||||
| Interventional Guidance | |||||||||||
| Intracardiac and Intraluminal | P3 | P3 | P3 | P3 | P3 | P3 | P3 | P3 | P3 | [9] | |
| Tissue Biopsy | |||||||||||
| Vascular Access (IV, PICC) |
P = previously cleared by FDA on Vivid S60 (K142323); P1 = previously cleared by FDA on LOGIQ E9 (K163077); P2 = previously cleared by FDA on Vivid E90/Vivid E95 (K150087); P3 = previously cleared by FDA on Vivid iq (K161706); N = New indication.
Notes: Abdominal includes renal, GYN/Pelvic [1]
Abdominal includes Aorto-Iliac Artery [2]
[3] Small organ includes breast, testes, thyroid.
Cardiac is Adult and Pediatric. [4]
Other use includes Urology/Prostate [5]
3D/4D Imaging mode [6]
[7] Includes image guidance for freehand needle placement
Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8]
Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD [a]
System provides real-time 3D and 4D acquisition when used with special 4D probes.
(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)
23
Image /page/23/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 script inside. There are small white flourishes around the edge of the circle. The blue color is a medium shade, and the overall design is simple and recognizable.
Diagnostic Ultrasound Indications for Use Form GE Vivid S60N / Vivid S70N with SOUNDSTAR eco 10F (G version) 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 | |||||||||||
| Abdominal | |||||||||||
| Pediatric | |||||||||||
| Small Organ | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Peripheral Vascular | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular | |||||||||||
| Interventional Guidance | |||||||||||
| Intracardiac and Intraluminal | P3 | P3 | P3 | P3 | P3 | P3 | P3 | P3 | P3 | P3 | [9] |
| Tissue Biopsy |
P = previously cleared by FDA on Vivid S60 (K142323); P1 = previously cleared by FDA on LOGIQ E9 (K163077); P2 = previously cleared by FDA on Vivid E90/Vivid E95 (K150087); P3 = previously cleared by FDA on Vivid iq (K161706); N = New indication.
Notes: Abdominal includes renal, GYN/Pelvic [1]
Abdominal includes Aorto-Iliac Artery [2]
[3] Small organ includes breast, testes, thyroid.
Cardiac is Adult and Pediatric. [4]
Other use includes Urology/Prostate [5]
3D/4D Imaging mode [6]
[7] Includes image guidance for freehand needle placement
Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8]
Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD [a]
System provides real-time 3D and 4D acquisition when used with special 4D probes.
(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)
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Diagnostic Ultrasound Indications for Use Form GE Vivid S60N / Vivid S70N with SOUNDSTAR eco 8F (G version) 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 | |||||||||||
| Abdominal | |||||||||||
| Pediatric | |||||||||||
| Small Organ | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Peripheral Vascular | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular | |||||||||||
| Interventional Guidance | |||||||||||
| Intracardiac and Intraluminal | P3 | P3 | P3 | P3 | P3 | P3 | P3 | P3 | P3 | [9] | |
| Tissue Biopsy | |||||||||||
| Vascular Access (IV, PICC) |
P = previously cleared by FDA on Vivid S60 (K142323); P1 = previously cleared by FDA on LOGIQ E9 (K163077); P2 = previously cleared by FDA on Vivid E90/Vivid E95 (K150087); P3 = previously cleared by FDA on Vivid iq (K161706); N = New indication.
Notes: Abdominal includes renal, GYN/Pelvic [1]
Abdominal includes Aorto-Iliac Artery [2]
- [3] Small organ includes breast, testes, thyroid.
Cardiac is Adult and Pediatric. [4]
Other use includes Urology/Prostate [5]
3D/4D Imaging mode [6]
[7] Includes image guidance for freehand needle placement
Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8]
Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD [a]
System provides real-time 3D and 4D acquisition when used with special 4D probes.
(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)
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510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | March 23, 2017 |
|---|---|
| Submitter: | GE Medical Systems Ultrasound and Primary Care Diagnostics |
| 9900 Innovation Drive | |
| Wauwatosa, WI 53226 | |
| Primary Contact Person: | Tracey Ortiz |
| Regulatory Affairs Director | |
| GE Healthcare | |
| T:(262)676-6120 | |
| F:(414)918-8275 | |
| Secondary Contact Person: | Carmel Lehrer |
| Regulatory Affairs Specialist | |
| GE Vingmed Ultrasound AS | |
| Device: | |
| Trade Name: | Vivid S60N, Vivid S70N |
| Common/Usual Name: | Diagnostic 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 | |
| Primary Predicate Device: | Vivid S60, Vivid S70 (K142323) |
| Secondary Predicate | |
| Device(s): | Vivid E80, Vivid E90, Vivid E95 (K150087) |
| Vivid iq (K161706) | |
| LOGIQ E9 (K163077) | |
| TomTec Arena TTA2 (K150122) | |
| Device Description: | Vivid S60N / Vivid S70N is a Track 3 diagnostic ultrasound |
| system, which is primarily intended for cardiac imaging and | |
| analysis but also includes vascular and general radiology | |
| applications. It is a full featured diagnostic ultrasound system that | |
| provides digital acquisition, processing, analysis and display | |
| capability. |
The Vivid S60N / Vivid S70N consists of a mobile console with a
height-adjustable control panel, color LCD touch panel, LCD
display monitor and optional image storage and printing devices.
It includes a variety of electronic array transducers operating in
linear, curved, sector/phased array, matrix array or dual array
format, including dedicated CW transducers and real time 3D
transducer. |
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Image /page/26/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 is made up of swirling, wave-like lines, giving it a dynamic and fluid appearance. The logo is presented in a blue color scheme.
The system includes electronics for transmit and receive of ultrasound data, ultrasound signal processing, software computing, hardware for Image storage, hard copy printing, and network access to the facility through both LAN and wireless (supported by use of a wireless LAN USB-adapter) connection.
Vivid S60N/Vivid S70N is a general-purpose ultrasound system, Intended Use: specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified physician for ultrasound imaging and analysis for the following applications: Fetal/Obstetrics; Abdominal (Including Renal & Gyn); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional: Musculo-skeletal Superficial: Urology (including prostate); Transesophageal; Transvaginal; Transrectal; Intra-cardiac and Intra-luminal.
-
Technology: The Vivid S60N / Vivid S70N employs the same fundamental scientific technology as its predicate devices.
Determination of Comparison to Predicate Devices Substantial Equivalence: The Vivid S60N / Vivid S70N systems are substantially equivalent to the predicate devices with regards to intended use, imaging capabilities, technological characteristics and safety and effectiveness. -
. The transducers used on the proposed Vivid S60N / Vivid S70N systems include all the transducers used on the predicate Vivid S60 / Vivid S70 (K142323) and include those added under Appendix E: 9T-RS, 3Sc-RS, 11L-D, P6D, C2-9-D, C3-10-D.
-
Adding 5 ICE (Intra-CardiacEchocardiography) probes that were previously cleared on Vivid ig (K161706).
-
Adding IC5-9-D probe previously cleared on Vivid E95/E90/E80 (K150087). The proposed Vivid S60N / Vivid S70N expands on the indications for use of Vivid S60 / Vivid S70 (K142323) and adds Intra-cardiac, Intra-luminal, Transvaginal, Transrectal, Musculo-skeletal Superficial from the cleared Vivid iq (K161706).
-
The new feature "4D Auto MVO" is an alternative ● implementation of functionality offered with TomTec Arena
27
GE Healthcare
Image /page/27/Picture/1 description: The image shows the General Electric (GE) logo. The logo is a blue circle with the letters "ge" in a stylized, cursive font. The letters are white and are surrounded by a blue background. There are decorative swirls around the circle.
510(k) Premarket Notification Submission
(K150122) as available on the predicate Vivid E80 / Vivid E90 / Vivid E95 (K150087).
- "4D Auto AVQ" is a new functionality migrated from the ● predicate Vivid E80 / Vivid E90 / Vivid E95 (K150087).
- "Cardiac AutoDoppler", "FlexiViews" and "QuickApps" are ● workflow improvements of functionality already available on the predicate Vivid E80 / Vivid E90 / Vivid E95 (K150087)
- . "Virtual Convex" is a new imaging technique used with linear transducers as migrated from the predicate LOGIQ E9 (K163077)
- View-X: Picture-in picture viewing of an external video signal will be available through direct streaming from a VGADVI device. The video signal, which can be toggled On/Off by the user, is for visualization only.
Summary of Non-Clinical Tests:
Vivid S60N / Vivid S70N 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 comply with applicable medical device safety standards. The Vivid S60N / Vivid S70N complies with voluntary standards:
- ANSI / AAMI ES60601-1, Medical Electrical Equipment -● Part 1: General Requirements for Safety, 2005/A1:2012
- IEC60601-1-2, Medical Electrical Equipment Part 1-2: ● General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility Requirements and Tests, 2007.
- IEC60601-2-37, Medical Electrical Equipment Part 2-37: ● Particular Requirements for the Basic Safety and Essential Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment, 2007-08.
- NEMA UD 3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment, 2004
- ISO10993-1, Biological Evaluation of Medical Devices- Part ● 1: Evaluation and Testing- Third Edition, 2009
- NEMA UD 2, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment, 2004
- ISO14971, Application of risk management to medical ● devices, 2007
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-
NEMA, Digital Imaging and Communications in Medicine ● (DICOM) Set. (Radiology), 2016
The following quality assurance measures were applied to the development of the system: -
Risk Analysis
-
Usability Analysis ●
-
Requirements Reviews ●
-
. Design Reviews
-
Testing on unit level (Module verification) .
-
Integration testing (System verification) ●
-
Performance testing (Verification) ●
-
Safety testing (Verification) .
-
Simulated use testing (Validation)
Transducer materials and other patient contact materials are biocompatible.
Summary of Clinical Tests:
The subject of this premarket submission, Vivid S60N / Vivid S70N, did not require clinical studies to support substantial equivalence.
- Conclusion: GE Healthcare considers the Vivid S60N / Vivid S70N to be as safe, as effective, and performance is substantially equivalent to the predicate device(s).