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Cios Fusion

by Siemens Medical Solutions USA, Inc.

510(k) K153244

Cios Fusion is a Class II device made by Siemens Medical Solutions USA, Inc., cleared under FDA 510(k) K153244 on 7 Mar 2016, active as of 22 Oct 2026. One FDA recall is linked to it.

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

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 NumberK153244 Date7 Mar 2016ClearedStatusActive

Official records

Recalls

1 recall · FDA

    • Terminated Z-1954-2019 FDA Class II initiated 20 Jun 2019

    DAP chamber may be missing an insulating foil

Timeline

2 dated events

  1. Cleared FDA 510(k) K153244
  2. Recall initiated FDA recalls Z-1954-2019

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  • Withdrawn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

Related clearances

cited in the FDA summary

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

Cites

Cited by

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

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