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Somatom Perspective

by Siemens Medical Solutions USA, Inc. 3 variants

510(k) K133590

Somatom Perspective is a Class II device made by Siemens Medical Solutions USA, Inc., cleared under FDA 510(k) K133590 on 30 Apr 2014, 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 NumberK133590 Date30 Apr 2014ClearedStatusActive

Official records

Recalls

1 recall · FDA

    • Terminated Z-1646-2015 FDA Class II initiated 20 Apr 2015

    Software bugs in VC20B SP0a or SP1 software versions may cause issues that could make it necessary to rescan patients. Syngo Main UI may crash if the Patient Browser is scrolled with arrow keys of the keyboard. Tomo images may freeze on the screen when zoomed in or out under the mode of CAREVision. Sporadic displaying error in WorkStream4D application. DB may lock under heavy and multitasks.

Timeline

2 dated events

  1. Cleared FDA 510(k) K133590
  2. Recall initiated FDA recalls Z-1646-2015

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  • Withdrawn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 K133590

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 K133590
UDI-DISize and differences
Somatom Perspective (DE) 10046733
Siemens Healthcare GmbH
1004673304056869013039 —On the market
Somatom Perspective (DE) 10046734
Siemens Healthcare GmbH
1004673404056869013046 —On the market
Somatom Perspective 10495568
Siemens Shanghai Medical Equipment Ltd.
1049556804056869010335 —On the market
Somatom Perspective SSME 10891666
Siemens Shanghai Medical Equipment Ltd.
1089166604056869010342 —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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