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Siremobil Iso-C 3D

by Siemens Medical Systems, Inc.

510(k) K040347

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 NumberK040347 Date9 Mar 2004ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0122-06 FDA Unclassified (pre-2012) initiated 1 Aug 2005 on shared 510(k) K040347

    Screws may become loose and fall into the OR field during surgery.

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  • Withdrawn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

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