# K182450: Vivid S60N, Vivid S70N

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems Ultrasound and Primary Care Diagnostics
- Decided: Oct 19, 2018 after 42 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 23 generations back to K935595 (1995). 257 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 267 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170878: Vivid S60N, Vivid S70N, GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC (2017) Summary page 5.
- K173341: Vivid E80, Vivid E90, Vivid E95, GE Medical Systems (2017) Summary page 5.
- K163077: LOGIQ E9, LOGIQ E9 XDClear 2.0, GE Medical Systems Ultrasound and Primary Care Diagnostics (2016) Summary page 5.

## Most influential descendants
- K200497: Vivid S60N, Vivid S70N (2020), 4 descendants of its own
- K211216: Vivid S60N / Vivid S70N (2021), 3 descendants of its own
- K200852: EchoPAC Software Only, EchoPAC Plug-In (2020), 3 descendants of its own
- K220940: EchoPAC Software Only, EchoPAC Plug-in (2022), 2 descendants of its own
- K220619: Vivid S60N, Vivid S70N (2022), 2 descendants of its own

## Recalls of this device
- May 30, 2023 · Class II · Z-2127-2023: 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-2126-2023: 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
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; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional; Musculo-skeletal Superficial; Urology (including prostate); Transesophageal; Transvaginal; Transrectal; Intra-cardiac; Intra-luminal and Intraoperative (abdominal, thoracic, & vascular).

Source page: https://510kreport.com/device/K182450
Methodology: https://510kreport.com/methodology