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Siremobil Compact

by Siemens Medical Solutions USA, Inc.

510(k) K963093

Siremobil Compact is a Class II device made by Siemens Medical Solutions USA, Inc., cleared under FDA 510(k) K963093 on 3 Sep 1996, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK963093 Date3 Sep 1996ClearedStatusActive

Official records

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0120-06 FDA Unclassified (pre-2012) initiated 1 Aug 2005 on shared 510(k) K963093
    • Terminated Z-0121-06 FDA Unclassified (pre-2012) initiated 1 Aug 2005 on shared 510(k) K963093

    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.

Timeline

3 dated events

  1. Cleared FDA 510(k) K963093
  2. Recall initiated FDA recalls Z-0120-06
  3. Recall initiated FDA recalls Z-0121-06

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  • Withdrawn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

Related clearances

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Similar devices

Other devices filed under FDA product code OXO (Image-Intensified Fluoroscopic X-Ray System, Mobile).

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