FDA.reportPublic FDA data

ClearRead CT Platform Docker

Primary DI
M722CP26104V261040
Brand
ClearRead CT Platform Docker
Company
Riverain Technologies, Inc.
Model
5.11.1
Device description
ClearRead CT Platform Docker
Published
2026-04-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
M722CP26104V261040PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Radiological PACS softwareAn individual software application intended to be installed on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of radiological images.

Regulatory Flags#

DUNS number
172223922
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M722CD26127V260970ClearRead CT Docker5.11.22026-05-28
M722CD26112CA252790ClearRead CT CAC Docker1.2.32026-05-07
M722C26103V260970ClearRead CT Server5.11.12026-04-20
M722CC26103V260970ClearRead CT Console5.11.12026-04-20
M722CD26103V260970ClearRead CT Docker5.11.12026-04-20
M722X25122B250640ClearRead Xray Bone Suppress5.0.02025-06-17
M722X25122C250640ClearRead Xray Detect7.0.02025-06-17
M722X25122E250640ClearRead Xray Enhance4.0.02025-06-17
M722X25122P250640ClearRead Xray Pneumothorax2.0.02025-06-17
M722X25122T250640ClearRead Xray Compare5.0.02025-06-17
M722XC25114B250640ClearRead Xray Bone Suppress5.0.02025-06-17
M722XC25114C250640ClearRead Xray Detect7.0.02025-06-17
M722XC25114E250640ClearRead Xray Enhance4.0.02025-06-17
M722XC25114P250640ClearRead Xray Pneumothorax2.0.02025-06-17
M722XC25114T250640ClearRead Xray Compare5.0.02025-06-17
M722XD25114B250640ClearRead Xray Bone Suppress5.0.02025-06-17
M722XD25114C250640ClearRead Xray Detect7.0.02025-06-17
M722XD25114E250640ClearRead Xray Enhance4.0.02025-06-17
M722XD25114P250640ClearRead Xray Pneumothorax2.0.02025-06-17
M722XD25114T250640ClearRead Xray Compare5.0.02025-06-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260483290305MeVis AVM ContourMeVis Medical Solutions AGLLZ2026-07-09
G775EVOLVE4140EVOLVESmaart Medical Systems, Inc.LLZ2026-07-09
080563044562053mensio WorkstationPie Medical Imaging B.V.LLZ2026-07-08
00850059977576TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977583TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977590TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977606TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977613TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977521TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977538TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977545TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977552TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977569TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00889024673403NavitrackER®Orthosoft IncLLZ2026-06-26
00889024699762ROSA® ShoulderOrthosoft IncLLZ2026-06-26
00889024699779ROSA® ShoulderOrthosoft IncLLZ2026-06-26
00889024699786ROSA® ShoulderOrthosoft IncLLZ2026-06-26
00889024699793ROSA® ShoulderOrthosoft IncLLZ2026-06-26
00889024699809ROSA® ShoulderOrthosoft IncLLZ2026-06-26
00889024699816ROSA® ShoulderOrthosoft IncLLZ2026-06-26
00889024699823ROSA® ShoulderOrthosoft IncLLZ2026-06-26
00860012615308Denti.AI Auto-ChartDenti.AI Technology IncLLZ2026-06-24
00860012615315Denti.AI DetectDenti.AI Technology IncLLZ2026-06-24
00850631008872Roentgen WorksBrit Systems, LLCLLZ2026-06-23
00628184004500Intellijoint VIEWIntellijoint Surgical IncLLZ2026-06-09
00860005144082Brain AgeDeephealth, Inc.LLZ2026-06-08
07649997938038Swissmeda Dental Planning SystemSwissmeda AGLLZ2026-06-08
07649997938052Swissmeda Dental Planning SystemSwissmeda AGLLZ2026-06-08
00850025268417Vitrea Advanced VisualizationCanon Medical Informatics, Inc.LLZ2026-06-05
00850631008865Roentgen WorksBrit Systems, LLCLLZ2026-06-05