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ClearRead CT Platform Docker 5.11

by Riverain Technologies, Inc.

ClearRead CT Platform Docker 5.11 is a radiological PACS-dedicated management software (FDA Class II) made by Riverain Technologies, Inc., cleared under FDA 510(k) K221612 on 5 Dec 2022 (1 earlier submission) and listed in FDA GUDID since 26 Aug 2025 (UDI-DI M722CP25215V252150), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberM722CP25215V252150 UDI-DI Date26 Aug 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK221612 Date5 Dec 2022IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K221612 decided 5 Dec 2022 Active· +1 more in the status table
  • FDA GUDID UDI-DI M722CP25215V252150 listed 26 Aug 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K161201
  2. Cleared FDA 510(k) K221612
  3. Listed FDA GUDID M722CP25215V252150

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
ClearRead CT Platform Docker
Generic name
Radiological PACS-dedicated management software
Model / reference
5.11
Primary DI / UDI-DI
M722CP25215V252150
510(k) Number
FDA product code
OEB, LLZ
GMDN term
Radiological PACS-dedicated management software
Device class
Class II
Regulation number
892.2050
GUDID distribution status
In Commercial Distribution

Related devices

Category: Radiological PACS software

Cleared under the same submission (K161201)

Cleared under the same submission (K221612)

Similar devices in this category

Other devices filed under Radiological PACS software.

Other devices from Riverain Technologies, Inc.

See all devices from Riverain Technologies, Inc. →

Properties

  • Serial number
Other properties (14, all answered No)