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
17540262200096Change Healthcare Stratus Imaging Diagnostic ViewerChange Healthcare Canada CompanyLLZ2026-05-27
75401622522101Synthesis Vision ViewerSynthesis Health Intelligence IncLLZ2026-05-27
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
M722CD26103V260970ClearRead CT DockerRiverain Technologies, Inc.OEB2026-04-20
M722CD26103V260970ClearRead CT DockerRiverain 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