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Standard Imaging LinacView Software 91330

by Standard Imaging Inc.

Ref 91330

Standard Imaging LinacView Software 91330 is a device classified as Class I in the EU and Class II in the US made by Standard Imaging Inc., registered in EUDAMED on 19 May 2026 (Basic UDI-DI 08665620002LINACVIEWHF) and listed in FDA GUDID since 20 Dec 2017 (UDI-DI 00866562000267), 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 Number08665620002LINACVIEWHF Basic UDI-DI 00866562000267UDI-DIDate19 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00866562000267 UDI-DI Date20 Dec 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08665620002LINACVIEWHF registered 19 May 2026 Active
  • FDA GUDID UDI-DI 00866562000267 listed 20 Dec 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00866562000267
  2. Registered EUDAMED 08665620002LINACVIEWHF

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  • Withdrawn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
LinacView EUDAMED
Standard Imaging LinacView Software GUDID
Generic name
Radiation therapy software
Model / Ref / Catalog
91330
Primary DI / UDI-DI
00866562000267
Basic UDI-DI
08665620002LINACVIEWHF
FDA product code
IYE
EMDN code
Z11010182 Linear accelerators - software accessories
GMDN term
Radiation therapy software
Device class
Class I EUDAMED
Class II GUDID
Regulation number
892.5050
Special device type
Software
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Radiation therapy software

Similar devices in this category

Other devices filed under LINEAR ACCELERATORS.

Other devices from Standard Imaging Inc.

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Properties

  • Prescription use
Other properties (24, all answered No)