FDA.reportPublic FDA data

ClearRead Xray Pneumothorax

Primary DI
M722X25064P250640
Brand
ClearRead Xray Pneumothorax
Company
Riverain Technologies, Inc.
Model
2.0.0
Device description
ClearRead Xray Server Pneumothorax
Published
2025-03-27
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
QFMRadiological Computer-Assisted Prioritization Software For Lesions

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QFMRadiological Computer-Assisted Prioritization Software For LesionsRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M722X25064P250640PrimaryHIBCC0

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
true
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
M722CD25211V252110ClearRead CT Docker5.112025-08-26
M722C25119V251130ClearRead CT Server5.8.52025-06-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860007434716Cognet AIMedcognetics IncQFM2026-05-21
07290018052365BriefCase TriageAIDOC MEDICAL LTDQFM2026-02-15
G140ANNALISECONTAINER60Annalise Critical Care AIHARRISON-AI MEDICAL PTY LTDQFM2025-07-28
G140ANNALISEENTP60Annalise TriageHARRISON-AI MEDICAL PTY LTDQFM2025-07-24
G140ANNALISECONTAINER70Annalise TriageHARRISON-AI MEDICAL PTY LTDQFM2025-07-02
M722X25122P250640ClearRead Xray PneumothoraxRiverain Technologies, Inc.QFM2025-06-17
M722XC25114P250640ClearRead Xray PneumothoraxRiverain Technologies, Inc.QFM2025-06-17
M722XD25114P250640ClearRead Xray PneumothoraxRiverain Technologies, Inc.QFM2025-06-17
B761R60RapidIschemaview, Inc.QFM2025-05-07
03770024774016SmartChestMILVUEQFM2025-03-31
M722XC25064P250640ClearRead Xray PneumothoraxRiverain Technologies, Inc.QFM2025-03-27
M722XD25064P250640ClearRead Xray PneumothoraxRiverain Technologies, Inc.QFM2025-03-27
07290018052273BriefCase TriageAIDOC MEDICAL LTDQFM2024-11-24
07290018052297BriefCase TriageAIDOC MEDICAL LTDQFM2024-11-24
08800045800342VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link TriageVUNO Inc.QFM2024-11-19
B826CINAVCF100CINA-VCFAVICENNA.AIQFM2024-06-20
M722XD24079P212210ClearRead Xray | PneumothoraxRiverain Technologies, Inc.QFM2024-04-15
08800076000179Lunit INSIGHT CXR TriageLunit Inc.QFM2024-04-09
B761R51020RapidIschemaview, Inc.QFM2024-02-13
B761R610RapidIschemaview, Inc.QFM2024-02-13
G140ANNALISEENTP50Annalise TriageHARRISON-AI MEDICAL PTY LTDQFM2024-01-11
07290018052259BriefCase TriageAIDOC MEDICAL LTDQFM2023-12-27
G140ANNALISEENTP40Annalise TriageHARRISON-AI MEDICAL PTY LTDQFM2023-11-06
00860006442668cmTriageCuremetrix, Inc.QFM2023-10-31
00850057636017qXR-PTX-PEQURE.AI TECHNOLOGIES PRIVATE LIMITEDQFM2023-10-10
00860007434709Cognet AIMedcognetics IncQFM2023-09-11
G140ANNALISEENTP30Annalise EnterpriseHARRISON-AI MEDICAL PTY LTDQFM2023-07-24
07290018052211BriefCase TriageAIDOC MEDICAL LTDQFM2023-07-14
G140ANNALISEENTP20Annalise EnterpriseHARRISON-AI MEDICAL PTY LTDQFM2023-06-08
00811852030325Viz AAAVIZ.AI, INC.QFM2023-05-22