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Somatom Perspective 10495568

by Siemens Shanghai Medical Equipment Ltd.

Somatom Perspective 10495568 is a Class II device made by Siemens Shanghai Medical Equipment Ltd., cleared under FDA 510(k) K183548 on 15 Apr 2019 (3 earlier submissions) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 04056869010335), active as of 23 Oct 2026. 5 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

5 closed

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK183548 Date15 Apr 2019DecidedStatusActive
United StatesGUDID listing Number04056869010335 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K183548 decided 15 Apr 2019 Active· +3 more in the status table
  • FDA GUDID UDI-DI 04056869010335 listed 24 Sep 2016 Listed

Recalls

5 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

  • 2 recalls, same reason

    • Terminated Z-2474-2018 FDA Class II initiated 1 Feb 2018
    • Terminated Z-2475-2018 FDA Class II initiated 1 Feb 2018

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

    • 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.

    • 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

10 dated events

  1. Cleared FDA 510(k) K113287
  2. Cleared FDA 510(k) K133590
  3. Recall initiated FDA recalls Z-1646-2015
  4. Cleared FDA 510(k) K151765
  5. Listed FDA GUDID 04056869010335
  6. Recall initiated FDA recalls Z-0921-2017
  7. Recall initiated FDA recalls Z-2474-2018
  8. Recall initiated FDA recalls Z-2475-2018
  9. Recall initiated FDA recalls Z-1448-2018
  10. Cleared FDA 510(k) K183548

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Somatom Perspective
Generic name
Full-body CT system
Model / reference
10495568
Primary DI / UDI-DI
04056869010335
510(k) Number
FDA product code
JAK
GMDN term
Full-body CT system
Device class
Class II
Regulation number
892.1750
GUDID distribution status
In Commercial Distribution

Related devices

Category: Full-body CT system

Cleared under the same submission (K133590)

Cleared under the same submission (K183548)

Similar devices in this category

Other devices filed under Full-body CT system.

Other devices from Siemens Shanghai Medical Equipment Ltd.

See all devices from Siemens Shanghai Medical Equipment Ltd. →

Properties

  • Serial number
Other properties (14, all answered No)