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Somatom Perspective (DE) 10046733

by Siemens Healthcare GmbH

Somatom Perspective (DE) 10046733 is a Class II device made by Siemens Healthcare GmbH, cleared under FDA 510(k) K133590 on 30 Apr 2014 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 04056869013039), active as of 12 Nov 2026. One FDA recall is 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

1 closed

Documents

510(k) K133590

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04056869013039 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK133590 Date30 Apr 2014DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K133590 decided 30 Apr 2014 Active
  • FDA GUDID UDI-DI 04056869013039 listed 24 Sep 2016 Listed

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

3 dated events

  1. Cleared FDA 510(k) K133590
  2. Recall initiated FDA recalls Z-1646-2015
  3. Listed FDA GUDID 04056869013039

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  • Withdrawn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 (DE)
Generic name
Full-body CT system
Model / reference
10046733
Primary DI / UDI-DI
04056869013039
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)

Similar devices in this category

Other devices filed under Full-body CT system.

Other devices from Siemens Healthcare GmbH

See all devices from Siemens Healthcare GmbH →

Properties

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