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Somatom Scope/Somatom Scope Power

by Siemens Medical Solutions USA, Inc.

510(k) K140912

Somatom Scope/Somatom Scope Power is a Class II device made by Siemens Medical Solutions USA, Inc., cleared under FDA 510(k) K140912 on 15 Sep 2014, active as of 22 Oct 2026. 2 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

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 NumberK140912 Date15 Sep 2014ClearedStatusActive

Official records

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-2476-2018 FDA Class II initiated 1 Feb 2018
    • Terminated Z-2477-2018 FDA Class II initiated 1 Feb 2018

    A potential risk of unnecessary radiation exposure due to a software issue

Timeline

3 dated events

  1. Cleared FDA 510(k) K140912
  2. Recall initiated FDA recalls Z-2476-2018
  3. Recall initiated FDA recalls Z-2477-2018

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  • Withdrawn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
JAK
Device class
Class II
Regulation
21 CFR Part 892.1750
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

Devices cleared under K140912

4 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K140912
UDI-DISize and differences
SOMATOM Scope (DE) 10046798
Siemens Healthcare GmbH
1004679804056869013060 —On the market
SOMATOM Scope 10046799
Siemens Healthcare GmbH
1004679904056869013053 —On the market
SOMATOM Scope 10967666
Siemens Shanghai Medical Equipment Ltd.
1096766604056869010311 —On the market
SOMATOM Scope 10967888
Siemens Shanghai Medical Equipment Ltd.
1096788804056869010328 —On the market

Similar devices

Other devices filed under FDA product code JAK (System, X-Ray, Tomography, Computed).

Other devices from Siemens Medical Solutions USA, Inc.

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