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GE Logiq E9 Diagnostic Ultrasound System, Models 5205000, 5205000-2

by Ge Medical Systems Ultrasound and Primary Care Dia

510(k) K082185

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 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 · Special NumberK082185 Date15 Aug 2008ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2983-2018 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  • Withdrawn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
IYO
Device Class
Class II
Regulation
21 CFR Part 892.1560
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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