FDA.reportPublic FDA data

ClearRead CT Docker

Primary DI
M722CD26127V260970
Brand
ClearRead CT Docker
Company
Riverain Technologies, Inc.
Model
5.11.2
Device description
ClearRead CT Docker
Published
2026-05-28
Public version status
New
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
M722CD26127V260970PrimaryHIBCC0

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
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
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
M722CP26104V261040ClearRead CT Platform 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