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CAC Software

by 4D Medical Limited

Ref CAC Software

CAC Software is a device classified as Class IIa in the EU and Class II in the US made by 4DMEDICAL Limited, registered in EUDAMED on 19 Aug 2026 (Basic UDI-DI 193568700CACJM), cleared under FDA 510(k) K230112 on 13 Jun 2023 and listed in FDA GUDID since 13 Oct 2026 (UDI-DI 19356870000045), active as of 24 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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K230112

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number19356870000045 UDI-DI Date13 Oct 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number193568700CACJM Basic UDI-DI 19356870000045UDI-DIDate19 Aug 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK230112 Date13 Jun 2023DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 193568700CACJM registered 19 Aug 2026 Active
  • FDA 510(k) K230112 decided 13 Jun 2023 Active
  • FDA GUDID UDI-DI 19356870000045 listed 13 Oct 2026 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K230112
  2. Registered EUDAMED 193568700CACJM
  3. Listed FDA GUDID 19356870000045

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  • Withdrawn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
CAC Software EUDAMED
Cac GUDID
Generic name
Chest/vascular CT/MRI clinical assessment support software
Model / reference
CAC Software EUDAMED
3.1.x GUDID
Primary DI / UDI-DI
19356870000045
Basic UDI-DI
193568700CACJM
510(k) Number
FDA product code
JAK
EMDN code
Z11030699 Computed tomographs (CT) - other
GMDN term
Chest/vascular CT/MRI clinical assessment support software
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.1750
Special device type
Software
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
CAC Software
GUDID
3.1.x
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
AU-MF-000050621
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Similar devices in this category

Other devices filed under COMPUTED TOMOGRAPHS (CT) - OTHER.

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See all devices from 4DMEDICAL Limited →

Properties

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