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GE Definium Amx 700, Model Amx 700

by General Electric Medical Systems

510(k) K052897

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 NumberK052897 Date8 Nov 2005ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0821-2007 FDA Unclassified (pre-2012) initiated 21 Dec 2006

    When using the Tech Switch on exposures >750ms, >100 kVp and > 100 mAs the exposure terminates prematurely.

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  • Withdrawn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
IZL
Device Class
Class II
Regulation
21 CFR Part 892.1720
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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