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ClearRead CT CAC

by Riverain Technologies, Inc. 5 variants

Ref 1.2.3Model ClearRead CT CAC

ClearRead CT CAC (1.2.3) 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, cleared under FDA 510(k) K242188 on 3 Dec 2024 and listed in FDA GUDID since 7 May 2026 (UDI-DI M722CD26112CA252790), active as of 23 Oct 2026.

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

CE MDR 510(k)

Valid until

21 Feb 2027

CE MDR certificate

FDA recalls

None found

in data synced 23 Oct 2026

Documents

1 certificate

Certifier Intertek Medical Notified Body AB

510(k) K242188

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 NumberM722CD26112CA252790 UDI-DI Date7 May 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number++M722CCAUJ Basic UDI-DI M722CD26112CA252790UDI-DIDate1 May 2025RegisteredStatusActive
United StatesFDA 510(k) GUDID from GUDID NumberK242188 Date3 Dec 2024IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI ++M722CCAUJ registered 1 May 2025 Active· +1 more in the status table
  • FDA 510(k) K242188 decided 3 Dec 2024 Active
  • FDA GUDID UDI-DI M722CD26112CA252790 listed 7 May 2026 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

5 dated events

  1. Certificate issued EUDAMED 28620122197-02
  2. Cleared FDA 510(k) K242188
  3. Registered EUDAMED ++M722CCAUJ
  4. Listed FDA GUDID M722CD26112CA252790
  5. 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 FDA 510(k) Active

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, 1.2.3
Primary DI / UDI-DI
M722CD26112CA252790
Basic UDI-DI
++M722CCAUJ
Direct marketing DI
M722CD26112CA252790
510(k) Number
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
  • Serial number
Other properties (23, all answered No)