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Standard Imaging TomoScanner 91750

by Standard Imaging Inc.

Ref 91750

Standard Imaging TomoScanner 91750 is a Class I device made by Standard Imaging Inc., registered in EUDAMED on 19 May 2026 (Basic UDI-DI 0850019946WATERTANKU9) and listed in FDA GUDID since 22 Jun 2023 (UDI-DI 00850019946499), active as of 8 Nov 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0850019946WATERTANKU9 Basic UDI-DI 00850019946499UDI-DIDate19 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00850019946499 UDI-DI Date22 Jun 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0850019946WATERTANKU9 registered 19 May 2026 Active
  • FDA GUDID UDI-DI 00850019946499 listed 22 Jun 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00850019946499
  2. Registered EUDAMED 0850019946WATERTANKU9

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
TomoScanner EUDAMED
Standard Imaging TomoScanner GUDID
Generic name
Accelerator system quality assurance device
Device name
QA Water Phantom (1D-2D)
Model / Ref / Catalog
91750
Primary DI / UDI-DI
00850019946499
Basic UDI-DI
0850019946WATERTANKU9
FDA product code
LHO
EMDN code
Z11019082 Various radiotherapy and radiosurgery instruments - software accessories
GMDN term
Accelerator system quality assurance device
Device class
Class I
Regulation number
892.1940
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Related devices

Category: Accelerator system quality assurance device

Similar devices in this category

Other devices filed under VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS.

Other devices from Standard Imaging Inc.

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Properties

  • Prescription use
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)