FDA.reportPublic FDA data

ClearRead CT Docker

Primary DI
M722CD25211V252110
Brand
ClearRead CT Docker
Company
Riverain Technologies, Inc.
Model
5.11
Device description
ClearRead CT Docker
Published
2025-08-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological
OEBLung Computed Tomography System, Computer-Aided Detection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2
OEBLung Computed Tomography System, Computer-Aided DetectionRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161201000
K221612000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161201000ClearRead CTRiverain Technologies, LLC2016-09-09OEB
K221612000ClearRead CTRiverain Technologies, Inc.2022-12-05OEB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M722CD25211V252110PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Radiological PACS-dedicated management softwareA software program dedicated for installation on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of a broad range of radiological images throughout the healthcare system. As a PACS-dedicated software, it is not primarily intended for diagnosis support, triage, or treatment planning. It does not incorporate adaptive/dynamic machine learning (ML) models.

Regulatory Flags#

DUNS number
172223922
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M722CD26161V26097010ClearRead CT Docker for Partner5.11.2.362026-06-19
M722CD26177V26097010ClearRead CT Docker for Partner5.11.3.492026-07-02
M722CP26183V261830ClearRead CT Platform Docker5.11.32026-07-17
M722CD26127V260970ClearRead CT Docker5.11.22026-05-28
M722C25281CA252790ClearRead CT CAC Server1.2.22025-10-17
M722C26103V260970ClearRead CT Server5.11.12026-04-20
M722CC25281CA252790ClearRead CT CAC Console1.2.22025-10-17
M722CC26103V260970ClearRead CT Console5.11.12026-04-20
M722CD25030CA241430ClearRead CT CAC Docker1.2.02025-02-12
M722CD25281CA252790ClearRead CT CAC Docker1.2.22025-10-17
M722CD26103V260970ClearRead CT Docker5.11.12026-04-20
M722CD26112CA252790ClearRead CT CAC Docker1.2.32026-05-07
M722CP24281V242810ClearRead CT Platform Docker5.8.42024-10-16
M722CP25215V252150ClearRead CT Platform Docker5.112025-08-26
M722CP26104V261040ClearRead CT Platform Docker5.11.12026-04-20
M722XD25064T250640ClearRead Xray Compare5.0.02025-03-27
M722C25211V252110ClearRead CT Server5.112025-08-26
M722CC25211V252110ClearRead CT Console5.112025-08-26
M722C25119V251130ClearRead CT Server5.8.52025-06-17
M722C25133CA241430ClearRead CT CAC Server1.2.12025-06-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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05420060351242TRUMATCHMaterialise NVLLZ2026-10-22
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05420060351273TRUMATCHMaterialise NVLLZ2026-10-22
05420060351280TRUMATCHMaterialise NVLLZ2026-10-22
05420060351297TRUMATCHMaterialise NVLLZ2026-10-22
05420060351303TRUMATCHMaterialise NVLLZ2026-10-22
05420060351310TRUMATCHMaterialise NVLLZ2026-10-22
05420060351327TRUMATCHMaterialise NVLLZ2026-10-22
05420060351334TRUMATCHMaterialise NVLLZ2026-10-22
05420060351341TRUMATCHMaterialise NVLLZ2026-10-22
05420060351358TRUMATCHMaterialise NVLLZ2026-10-22
05420060351365TRUMATCHMaterialise NVLLZ2026-10-22
05420060351372TRUMATCHMaterialise NVLLZ2026-10-22
05420060351389TRUMATCHMaterialise NVLLZ2026-10-22
05420060351396TRUMATCHMaterialise NVLLZ2026-10-22
05420060351402TRUMATCHMaterialise NVLLZ2026-10-22
B621ICOBRAINCTP1X7Y0icobrain ctpicometrix NVLLZ2026-10-22
00850631008919Roentgen WorksBrit Systems, LLCLLZ2026-10-21
00850631008926Roentgen WorksBrit Systems, LLCLLZ2026-10-21
05420060351228TruMatch CMF Titanium 3D Printed SplintsMaterialise NVLLZ2026-10-20
TKRL0001F1540PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F1B80PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
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TKRL0001F6000PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F7300PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F7940PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F7F80PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F9F00PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20