# K142323: Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems Israel, Ltd.
- Decided: Oct 10, 2014 after 51 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 18 generations back to K935595 (1995). 135 ancestors in all.
84 later devices descend from it; 5 cite it directly.
0 of 220 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131514: GE Vivid E9 Diagnostic Ultrasound Imaging System, Ge Vingmed Ultrasound AS (2013) Summary page 6.
- K121063: Vivid S5 Diagnostic Ultrasound System, Vivid S6 Diagnostic Ultrasound System, Ge Medical System Israel, Ltd. (2012) Summary page 6.
- K141093: 6VT-D Ultrasound Transducer, Ge Vingmed Ultrasound AS (2014) Summary page 10.
- K123564: Logiq E9 Diagnostic Ultrasound System, GE Healthcare (2012) Summary page 13.

## Most influential descendants
- K150087: Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging System, Vivid E95 Diagnostic Ultrasound Imaging System (2015), 73 descendants of its own
- K161706: Vivid iq (2016), 46 descendants of its own
- K170714: Venue (2017), 35 descendants of its own
- K170823: Vivid E80, Vivid E90, Vivid E95 (2017), 35 descendants of its own
- K180599: Venue (2018), 28 descendants of its own

## Recalls of this device
- May 2, 2024 · Class II · Z-2317-2024: GE HealthCare has become aware of an issue with certain Vivid ultrasound systems where, due to a slow DICOM Worklist response time, incorrect patient name and demographics can be displayed on the ultr
- May 30, 2023 · Class II · Z-2124-2023: GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely fashion. If this occurs, it can delay availability of the device in time-critical emergency situations.
- May 30, 2023 · Class II · Z-2125-2023: GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely fashion. If this occurs, it can delay availability of the device in time-critical emergency situations.

## Indications for use
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/Obstetrics; Abdominal (Including Renal & Gyn); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatrics); Peripheral Vascular (PV); Musculo-skeletal Conventional; Urology (including prostate) and Transesophageal.

Source page: https://510kreport.com/device/K142323
Methodology: https://510kreport.com/methodology