Viz HCM

Primary DI
00811852030332
Brand
Viz HCM
Company
VIZ.AI, INC.
Model
Viz HCM Software
Device description
Viz HCM v1.1 (2024-06-19)
Published
2023-09-08
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
QXOCardiovascular Machine Learning-Based Notification Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QXOCardiovascular Machine Learning-Based Notification SoftwareCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN230003000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN230003000Viz HCMViz. Ai, Inc.2023-08-03QXO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811852030332PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811852030332008118520303328118520303320811852030332

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac electrophysiology application softwareA software program designed to add specific image processing and/or data analysis capabilities to a computer for the interpretation of cardiac electrophysiology parameters [e.g., electrocardiogram (ECG)]. It may provide risk assessment for cardiac events [e.g., acute myocardial infarction (AMI), acute myocardial ischemic injury (AMII)] and/or include the ability to record images and movies.

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
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
00811852030196Viz ANEURYSMViz ANEURYSM Software2022-07-05
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