HomeIsraelViz.ai Israel Ltd

Viz.ai Israel Ltd

Israel · Tel Aviv
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Saudi Arabia — 2 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
5listed device types
Class I 0Class II 5Class III 0
plus 20 registration records and 11 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
3registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
pendingnot queried
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States20 registration records, 11 510(k), 0 PMA, 1 excluded
Saudi Arabia3 confirmed, 0 excluded
Manufacturer names merged into this page: Viz.ai Israel Ltd · VIZ.AI, INC. · Viz.ai, Inc.
Same-named companies — This database also contains companies with near-identical names: Viz. Ai, Inc.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Israel
City
Tel Aviv

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

Company number
515538049
Registration status
Active
Incorporated
2016-10-27

Business registration data from Israel Companies Registrar, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

12018
12020
12021
42022
22023
12024
12025

FDA listed device types

System, Image Processing, Radiological 1Automated Radiological Image Processing Software 1Radiological Computer-Assisted Triage And Notification Software 1Radiological Computer-Assisted Prioritization Software For Lesions 1Cardiovascular Machine Learning-Based Notification Software 1

Registration details (sample)

MarketIdentifierNameClass / date
USK250354Viz Subdural+, Viz SUBDURAL PLUS2025-06-10
USK232363Viz HDS, Viz Volume Plus, Viz ICH+2024-02-05
USDEN230003Viz HCM2023-08-03
SAME0000004289SFDAA00018Viz ICH
SAME0000004288SFDAA00005Viz CTP

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