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Vivid E80, Vivid E90, Vivid E95

by GE Medical Systems, LLC

510(k) K173341

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK173341 Date2 Nov 2017ClearedStatusActive

Recalls

3 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-2986-2018 FDA Class II initiated 22 Mar 2018
    • Terminated Z-2988-2018 FDA Class II initiated 22 Mar 2018
    • Terminated Z-2987-2018 FDA Class II initiated 22 Mar 2018

    The system side of the power cord may break and expose the electrical conductors leading to the risk of shock.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
IYN
FDA applicant
GE Medical Systems
Device Class
Class II
Regulation
21 CFR Part 892.1550
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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