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Angiostar

by Siemens Medical Solutions USA, Inc.

510(k) K884912

Angiostar is a Class II device made by Siemens Medical Solutions USA, Inc., cleared under FDA 510(k) K884912 on 16 Feb 1989, active as of 22 Oct 2026. 3 FDA recalls are linked to it.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 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 NumberK884912 Date16 Feb 1989ClearedStatusActive

Official records

Recalls

3 recalls · FDA

    • Terminated Z-0166-2010 FDA Unclassified (pre-2012) initiated 1 Jul 2009

    The table swivel locking mechanism may not completely engage adn could result in uncontrolled patient movement during transfer resulting in a patient fall.

  • 2 recalls, same reason

    • Terminated Z-0133-2009 FDA Unclassified (pre-2012) initiated 11 Aug 2008
    • Terminated Z-0134-2009 FDA Unclassified (pre-2012) initiated 11 Aug 2008

    Unintended movement of the system table and/or C arm.

Timeline

4 dated events

  1. Cleared FDA 510(k) K884912
  2. Recall initiated FDA recalls Z-0133-2009
  3. Recall initiated FDA recalls Z-0134-2009
  4. Recall initiated FDA recalls Z-0166-2010

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  • Withdrawn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
IZI
Device class
Class II
Regulation
21 CFR Part 892.1600
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Similar devices

Other devices filed under FDA product code IZI (System, X-Ray, Angiographic).

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