FDA.reportPublic FDA data

Viz ANEURYSM

Primary DI
00811852030196
Brand
Viz ANEURYSM
Company
VIZ.AI, INC.
Model
Viz ANEURYSM Software
Device description
Viz ANEURYSM v1.9 (2025-05-06)
Published
2022-07-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213319000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213319000Viz ANEURYSM, Viz ANXViz. Ai, Inc.2022-02-18QFM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811852030196PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811852030196008118520301968118520301960811852030196

GMDN Terms#

Term, Definition table
TermDefinition
Radiology DICOM image processing application softwareA software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/ disc burning) and/or image manipulation and quantification (e.g., non-interpretive graphical overlays).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(415)663-6130greg@viz.ai

Regulatory Flags#

DUNS number
080594139
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811852030301Viz LVOViz LVO Software2022-04-06
00811852030288Viz CTPViz CTP Software2022-03-15
00811852030271Viz SDH (Viz Subdural)Viz SDH Software2023-01-18
00811852030332Viz HCMViz HCM Software2023-09-08
00811852030363Viz Subdural+Viz Subdural+ Software2025-07-07
00811852030349Viz ICH+Viz ICH+ Software2024-08-12
00811852030295Viz RV/LVViz RV/LV Software2023-01-12
00811852030318Viz ICHViz ICH Software2022-04-06
00811852030325Viz AAAViz AAA Software2023-05-22
00811852030134Viz LVO1.92020-01-14
00811852030141Viz CTP1.42020-03-05
00811852030189Viz LVO1.112020-06-04
00811852030172Viz LVO1.102020-04-17
00811852030097Viz LVO1.72019-08-13
00811852030165Viz ICH1.32020-04-03
00811852030103Viz CTP1.32019-08-20
00811852030110Viz LVO1.82019-10-07
00811852030080Viz LVO1.62019-07-02
00811852030066Viz CTP1.22019-04-02
00811852030073Viz LVO1.52019-04-21

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
B761R60Rapid Ischemaview, Inc.QFM2025-05-07
03770024774016SmartChestMILVUEQFM2025-03-31
M722X25064P250640ClearRead Xray PneumothoraxRiverain Technologies, Inc.QFM2025-03-27
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