Skip to content

Standard Imaging IMSure QA Software v3

by Standard Imaging Inc.

Ref 91326

Standard Imaging IMSure QA Software v3 (91326) 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 18 May 2026 (Basic UDI-DI 08665620002IMSURE8S), cleared under FDA 510(k) K031975 on 29 Aug 2003 and listed in FDA GUDID since 11 Oct 2016 (UDI-DI 00866562000229), active as of 8 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 8 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K031975

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08665620002IMSURE8S Basic UDI-DI 00866562000229UDI-DIDate18 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00866562000229 UDI-DI Date11 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK031975 Date29 Aug 2003DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08665620002IMSURE8S registered 18 May 2026 Active
  • FDA 510(k) K031975 decided 29 Aug 2003 Active
  • FDA GUDID UDI-DI 00866562000229 listed 11 Oct 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K031975
  2. Listed FDA GUDID 00866562000229
  3. Registered EUDAMED 08665620002IMSURE8S

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
IMSure QA EUDAMED
Standard Imaging IMSure QA Software GUDID
Generic name
Radiation therapy software
Device name
IMSure
Model / Ref / Catalog
91326, v3
Primary DI / UDI-DI
00866562000229
Basic UDI-DI
08665620002IMSURE8S
510(k) Number
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 · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
91326
GUDID
v3
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.

See all devices from Standard Imaging Inc. →

Properties

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