FDA.reportPublic FDA data

Viz ICH+

Primary DI
00811852030349
Brand
Viz ICH+
Company
VIZ.AI, INC.
Model
Viz ICH+ Software
Device description
Viz ICH+ v1.24 (2026-08-03)
Published
2024-08-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
QIHAutomated Radiological Image Processing Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QIHAutomated Radiological Image Processing SoftwareRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232363000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232363000Viz HDS, Viz Volume Plus, Viz ICH+Viz. Ai, Inc.2024-02-05QIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811852030349PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811852030349008118520303498118520303490811852030349

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 quality manipulation and quantification (e.g., non-interpretive graphical overlays).

Contacts#

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

Regulatory Flags#

DUNS number
080594139
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
00811852030370Viz ICHViz ICH Software2026-08-03
00811852030363Viz Subdural+Viz Subdural+ Software2025-07-07
00811852030332Viz HCMViz HCM Software2023-09-08
00811852030325Viz AAAViz AAA Software2023-05-22
00811852030295Viz RV/LVViz RV/LV Software2023-01-12
00811852030196Viz ANEURYSMViz ANEURYSM Software2022-07-05
00811852030271Viz SDH (Viz Subdural)Viz SDH Software2023-01-18
00811852030301Viz LVOViz LVO Software2022-04-06
00811852030288Viz CTPViz CTP Software2022-03-15
00811852030318Viz ICHViz ICH Software2022-04-06
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

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00198953083253VolusonGE Healthcare Austria GmbH & Co OGQIH2026-10-09
00198953083260VolusonGE Healthcare Austria GmbH & Co OGQIH2026-10-09
00198953200421EchoPACGE Vingmed Ultrasound A/SQIH2026-10-07
00198953200438EchoPACGE Vingmed Ultrasound A/SQIH2026-10-07
04262352357645DS Core DiagnosisZetta25 AGQIH2026-10-06
00860006442651cmAngioCuremetrix, Inc.QIH2026-10-05
08809887550170EdgeFlow UH10CEdgeCare Inc.QIH2026-09-30
08809887550187EdgeFlow UH10EEdgeCare Inc.QIH2026-09-30
00195278985613NAGE Medical Systems (China) Co.,Ltd.QIH2026-09-24
00198953126073VividGE Vingmed Ultrasound A/SQIH2026-09-21
00198953172384VividGE Vingmed Ultrasound A/SQIH2026-09-21
00198953172551VividGE Vingmed Ultrasound A/SQIH2026-09-21
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00860006305734See-Mode TechnologiesSEE-MODE TECHNOLOGIES PTE. LTD.QIH2026-08-07
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