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Standard Imaging QA Pilot 91348

by Standard Imaging Inc.

Ref 91348

Standard Imaging QA Pilot 91348 is a Class I device made by Standard Imaging Inc., registered in EUDAMED on 19 May 2026 (Basic UDI-DI 08665620002QAPILOTJF) and listed in FDA GUDID since 22 Jun 2023 (UDI-DI 00866562000298), 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 Number08665620002QAPILOTJF Basic UDI-DI 00866562000298UDI-DIDate19 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00866562000298 UDI-DI Date22 Jun 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08665620002QAPILOTJF registered 19 May 2026 Active
  • FDA GUDID UDI-DI 00866562000298 listed 22 Jun 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00866562000298
  2. Registered EUDAMED 08665620002QAPILOTJF

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  • Withdrawn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
QA Pilot EUDAMED
Standard Imaging QA Pilot GUDID
Generic name
Radiation therapy software
Model / Ref / Catalog
91348
Primary DI / UDI-DI
00866562000298
Basic UDI-DI
08665620002QAPILOTJF
FDA product code
OUG
EMDN code
Z11010182 Linear accelerators - software accessories
GMDN term
Radiation therapy software
Device class
Class I
Regulation number
880.6310
Special device type
Software
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Related devices

Category: Radiation therapy software

Similar devices in this category

Other devices filed under LINEAR ACCELERATORS.

Other devices from Standard Imaging Inc.

See all devices from Standard Imaging Inc. →

Properties

  • Prescription use
  • Premarket exempt
Other properties (23, all answered No)