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SOMATOM Perspective

by Siemens Medical Solutions USA, Inc. 3 variants

510(k) K151765

SOMATOM Perspective is a Class II device made by Siemens Medical Solutions USA, Inc., cleared under FDA 510(k) K151765 on 25 Mar 2016, 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 NumberK151765 Date25 Mar 2016ClearedStatusActive

Official records

Recalls

2 recalls · FDA

    • Terminated Z-1448-2018 FDA Class II initiated 15 Feb 2018

    to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. Depending on the geometrical shape of the skull bone, it may happen in rare cases that the calculated dose distribution is not appropriate and could lead to unnecessary radiation exposure

    • Terminated Z-0921-2017 FDA Class II initiated 22 Nov 2016

    Siemens is providing a new installation of the Residual Current Monitor (RCM) in the Line Connection Box (LCB) to resolve a potential defect that could lead to a power cutout during use of the SOMATOM Scope, Scope Power and Perspective systems.

Timeline

3 dated events

  1. Cleared FDA 510(k) K151765
  2. Recall initiated FDA recalls Z-0921-2017
  3. Recall initiated FDA recalls Z-1448-2018

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  • Withdrawn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

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

Devices cleared under K151765

1 device · 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 K151765
UDI-DISize and differences
Somatom Perspective 10495568
Siemens Shanghai Medical Equipment Ltd.
1049556804056869010335 —On the market

Similar devices

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

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