FDA.reportPublic FDA data

ClearRead CT Docker

Primary DI
M722CD26103V260970
Brand
ClearRead CT Docker
Company
Riverain Technologies, Inc.
Model
5.11.1
Device description
ClearRead CT 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
M722CD26103V260970PrimaryHIBCC0

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
M722CD26112CA252790ClearRead CT CAC Docker1.2.32026-05-07
M722C26103V260970ClearRead CT Server5.11.12026-04-20
M722CC26103V260970ClearRead CT Console5.11.12026-04-20
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
M722C25281CA252790ClearRead CT CAC Server1.2.22025-10-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08437021722093ADAS 3DADAS3D MEDICAL S.L.LLZ2026-05-12
08800133400003ZeTTA PACSTae Young Soft Co., Ltd.LLZ2026-05-12
08033837938835no brandCEFLA SOCIETA' COOPERATIVALLZ2026-05-11
G725QFR300QFRQFR Solutions B.V.LLZ2026-05-11
G725QFR310QFRQFR Solutions B.V.LLZ2026-05-11
08800130800080Laon OrthoLaon Medi Inc.LLZ2026-05-07
G713ELU0010ElucisRealize Medical Inc.LLZ2026-05-07
08437021468045QP-Brain®QUIBIM SOCIEDAD LIMITADA.LLZ2026-05-06
08437023642016NemoCastSOFTWARE NEMOTEC SLLLZ2026-04-23
08437023642023NemoFABSOFTWARE NEMOTEC SLLLZ2026-04-23
M722C26103V260970ClearRead CT ServerRiverain Technologies, Inc.LLZ2026-04-20
M722C26103V260970ClearRead CT ServerRiverain Technologies, Inc.OEB2026-04-20
M722CC26103V260970ClearRead CT ConsoleRiverain Technologies, Inc.OEB2026-04-20
M722CC26103V260970ClearRead CT ConsoleRiverain Technologies, Inc.LLZ2026-04-20
M722CP26104V261040ClearRead CT Platform DockerRiverain Technologies, Inc.LLZ2026-04-20
M722CP26104V261040ClearRead CT Platform DockerRiverain Technologies, Inc.OEB2026-04-20
EOLENEUROINSIGHTV1P00Neuro InsightOlea Medical USALLZ2026-04-13
EOLENEUROVASIV1P00Neurovascular InsightOlea Medical USALLZ2026-04-13
08056304455864Caas QardiaPie Medical Imaging B.V.LLZ2026-04-03
08800290066784EVO Q10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.LLZ2026-04-03
08800340506147EVO QH10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.LLZ2026-04-03
08800340509988EVO XQ10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.LLZ2026-04-03
08800066200619JLK-AILINKJLK, Inc.LLZ2026-03-25
08800066200787JLK-CTPJLK, Inc.LLZ2026-03-25
08800066200794JLK-PWIJLK, Inc.LLZ2026-03-25
08800130400303Neurophet AQUA AD PlusNEUROPHET Inc.LLZ2026-02-24
08800290027471EV2-12SAMSUNG MEDISON CO., LTD.LLZ2026-01-28
08800290041767EA2-11AVSAMSUNG MEDISON CO., LTD.LLZ2026-01-28
08800290041811EA2-11ARSAMSUNG MEDISON CO., LTD.LLZ2026-01-28
08800290042481PA2-9SSAMSUNG MEDISON CO., LTD.LLZ2026-01-28