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ClearRead CT CAC

by Riverain Technologies, Inc. 5 variants

Ref 1.2.1Model ClearRead CT CAC

ClearRead CT CAC (1.2.1) is a radiological PACS-dedicated management software (EU MDR Class IIa; FDA Class II; FDA product code JAK, System, X-Ray, Tomography, Computed) made by Riverain Technologies, Inc., registered in EUDAMED on 1 May 2025 (Basic UDI-DI ++M722CCAUJ) with CE/MDR certificate 28620122197-02 valid until 21 Feb 2027 and listed in FDA GUDID since 17 Jun 2025 (UDI-DI M722CD25133CA241430), active as of 22 Oct 2026.

Expiring European Union. Also listed in GUDID (US).

CE MDR

Valid until

21 Feb 2027

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

1 certificate

Certifier Intertek Medical Notified Body AB

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID NumberM722CD25133CA241430 UDI-DI Date17 Jun 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number++M722CCAUJ Basic UDI-DI M722CD25133CA241430UDI-DIDate1 May 2025RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI ++M722CCAUJ registered 1 May 2025 Active· +1 more in the status table
  • FDA GUDID UDI-DI M722CD25133CA241430 listed 17 Jun 2025 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 28620122197-02 Expiring Supplemented Expires in 98 days

    Quality management system EU MDR

    Certifier
    Intertek Medical Notified Body AB 2862
    Issued
    31 Oct 2023
    Expires
    21 Feb 2027
    Reason
    Add device or group

Timeline

4 dated events

  1. Certificate issued EUDAMED 28620122197-02
  2. Registered EUDAMED ++M722CCAUJ
  3. Listed FDA GUDID M722CD25133CA241430
  4. Certificate expires EUDAMED 28620122197-02

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Expiring
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
ClearRead CT CAC EUDAMED
ClearRead CT CAC Docker GUDID
Generic name
Radiological PACS-dedicated management software
Model / reference
ClearRead CT CAC, 1.2.1
Primary DI / UDI-DI
M722CD25133CA241430
Basic UDI-DI
++M722CCAUJ
Direct marketing DI
M722CD25133CA241430
FDA product code
JAK
EMDN code
Z119092 Various bioimaging and radiotherapy instruments - medical device software
GMDN term
Radiological PACS-dedicated management 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
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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
US-MF-000003233
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Similar devices in this category

Other devices filed under VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - MEDICAL DEVICE SOFTWARE.

Other devices from Riverain Technologies, Inc.

See all devices from Riverain Technologies, Inc. →

Properties

  • Measuring function
  • Premarket exempt
  • Serial number
Other properties (22, all answered No)