Skip to content

Series 7600 Mobile Digital C-Arm

by Ge Dec Medical Systems

510(k) K970063

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 · Traditional NumberK970063 Date11 Mar 1997ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0716-2008 FDA Unclassified (pre-2012) initiated 28 Sep 2007 on shared 510(k) K970063

    Unnecessary operator exposure; X-ray machine may allow unwanted x-ray exposure to the operator.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
OWB
Device Class
Class II
Regulation
21 CFR Part 892.1650
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Other devices from Ge Dec Medical Systems

See all devices from Ge Dec Medical Systems →