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Siregraph Cf

by Siemens Medical Solutions USA, Inc.

510(k) K960266

Siregraph Cf is a Class II device made by Siemens Medical Solutions USA, Inc., cleared under FDA 510(k) K960266 on 11 Mar 1996, 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 NumberK960266 Date11 Mar 1996ClearedStatusActive

Official records

Recalls

3 recalls · FDA

    • Terminated Z-0189-2010 FDA Unclassified (pre-2012) initiated 23 Sep 2009

    possible injury to hand/fingers

  • 2 recalls, same reason

    • Terminated Z-1475-04 FDA Unclassified (pre-2012) initiated 7 Jun 2004
    • Terminated Z-1476-04 FDA Unclassified (pre-2012) initiated 7 Jun 2004

    X-ray tube movement when table is tilted more than 90 degrees

Timeline

4 dated events

  1. Cleared FDA 510(k) K960266
  2. Recall initiated FDA recalls Z-1475-04
  3. Recall initiated FDA recalls Z-1476-04
  4. Recall initiated FDA recalls Z-0189-2010

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  • Withdrawn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
JAA
Device class
Class II
Regulation
21 CFR Part 892.1650
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Similar devices

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

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