Skip to content

Sim&Size

by Sim&Cure 3 variants

Ref 2.1

Sim&Size (2.1) is a device classified as Class IIa in the EU and Class II in the US made by Sim&Cure, cleared under FDA 510(k) K253122 on 23 Dec 2025, registered in EUDAMED on 24 Nov 2025 (Basic UDI-DI 3665786S&SV323) and listed in FDA GUDID since 13 Mar 2026 (UDI-DI 03665786000018), active as of 23 Oct 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K253122

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number03665786000018 UDI-DI Date13 Mar 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK253122 Date23 Dec 2025IssuedStatusActive
European UnionCE/MDR EUDAMED Number3665786S&SV323 Basic UDI-DI 03665786000018UDI-DIDate24 Nov 2025RegisteredStatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K253122 decided 23 Dec 2025 Active
  • EUDAMED Basic UDI-DI 3665786S&SV323 registered 24 Nov 2025 Active
  • FDA GUDID UDI-DI 03665786000018 listed 13 Mar 2026 Listed

Timeline

3 dated events

  1. Registered EUDAMED 3665786S&SV323
  2. Cleared FDA 510(k) K253122
  3. Listed FDA GUDID 03665786000018

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  • Withdrawn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

Generic name
Radiology DICOM image processing application software
Model / reference
2.1 EUDAMED
v2.1 GUDID
Primary DI / UDI-DI
03665786000018
Basic UDI-DI
3665786S&SV323
510(k) Number
FDA product code
PZO
EMDN code
Z11030592 Radiology instruments - medical device software
GMDN term
Radiology DICOM image processing application software
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.2050
Special device type
Software
EU registration type
Standard device
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
2.1
GUDID
v2.1
Device classEUDAMED
Class IIa
GUDID
Class II

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

Manufacturer details

EUDAMED SRN
FR-MF-000000319

Similar devices in this category

Other devices filed under RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE.

Other devices from Sim&Cure

See all devices from Sim&Cure →

Properties

  • Measuring function
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)