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ClearRead CT

by Riverain Technologies, Inc. 34 variants

Part of a family of 43 devices: see the family page

Ref 5.11

ClearRead CT (5.11) is a radiological PACS-dedicated management software (EU MDR Class IIa; FDA Class II) made by Riverain Technologies, Inc., registered in EUDAMED on 8 Jul 2022 (Basic UDI-DI ++M722CVEB) with CE/MDR certificate 28620122197-02 valid until 21 Feb 2027, cleared under FDA 510(k) K221612 on 5 Dec 2022 (1 earlier submission) and listed in FDA GUDID since 26 Aug 2025 (UDI-DI M722C25211V252110), active as of 22 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 22 Oct 2026

Documents

1 certificate

Certifier Intertek Medical Notified Body AB

510(k) K221612

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID NumberM722C25211V252110 UDI-DI Date26 Aug 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number28620122197-02 Date31 Oct 2023IssuedStatusExpiring expires 21 Feb 2027
United StatesFDA 510(k) GUDID from GUDID NumberK221612 Date5 Dec 2022IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI ++M722CVEB registered 8 Jul 2022 Active· +1 more in the status table
  • FDA 510(k) K221612 decided 5 Dec 2022 Active· +1 more in the status table
  • FDA GUDID UDI-DI M722C25211V252110 listed 26 Aug 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

6 dated events

  1. Cleared FDA 510(k) K161201
  2. Registered EUDAMED ++M722CVEB
  3. Cleared FDA 510(k) K221612
  4. Certificate issued EUDAMED 28620122197-02
  5. Listed FDA GUDID M722C25211V252110
  6. 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 EUDAMED
ClearRead CT Server GUDID
Generic name
Radiological PACS-dedicated management software
Model / reference
5.11
Primary DI / UDI-DI
M722C25211V252110
Basic UDI-DI
++M722CVEB
Direct marketing DI
M722C25211V252110
510(k) Number
FDA product code
OEB, LLZ
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
892.2050
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 · 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)