FDA.reportPublic FDA data

Viz.ai Israel Ltd

Matched from indexed company URL: VIZ.AI, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30146657983014665798Viz.ai Israel Ltd1N2026-01-01150 Menachem Begin Tel Aviv IL 6492105
30146784413014678441VIZ.AI, INC.1N2026-01-015000 Center Green Way Cary NC US 27513

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00811852030271Viz SDH (Viz Subdural) - Viz SDH v1.7 (2025-12-03)+1(415)663-6130greg@viz.ai

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2199681007059041K250354Viz Subdural+, Viz SUBDURAL PLUSQIH2025-06-10
2203531007059041K250354Viz Subdural+, Viz SUBDURAL PLUSQIH2025-06-10
2199681114011390K232363Viz HDS, Viz Volume Plus, Viz ICH+QIH2024-02-05
2203531114011390K232363Viz HDS, Viz Volume Plus, Viz ICH+QIH2024-02-05
2199681345748441K223443Viz AAAQFM2023-03-17
2203531345748441K223443Viz AAAQFM2023-03-17
2199681667346166K223042Viz LVO ContaCTQAS2022-10-21
2203531667346166K223042Viz LVO ContaCTQAS2022-10-21
2199681597330663K221100Viz RV/LVQIH2022-08-29
2203531597330663K221100Viz RV/LVQIH2022-08-29
2199681971702741K220439Viz SDHQAS2022-07-25
2203531971702741K220439Viz SDHQAS2022-07-25
2199681380350308K213319Viz ANEURYSM, Viz ANXQFM2022-02-18
2203531380350308K213319Viz ANEURYSM, Viz ANXQFM2022-02-18
2199681552420594K210209Viz ICHQAS2021-03-23
2203531552420594K210209Viz ICHQAS2021-03-23
2199681425971857K193658Viz ICHQAS2020-03-18
2199681792201876K180161Viz CTPLLZ2018-04-20
2203531792201876K180161Viz CTPLLZ2018-04-20
2203531773978776DEN230003Viz HCMQXO2023-08-03
2199681773978776DEN230003Viz HCMQXO2023-08-03
2203531770619688DEN170073ContaCTQAS2018-02-13
2199681770619688DEN170073ContaCTQAS2018-02-13

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QAS92022-10-21
QIH62025-06-10
QFM42023-03-17
QXO22023-08-03
LLZ22018-04-20

PMN#

GUDID#