FDA.reportPublic FDA data

PRECISION AI PTY LTD

Matched from indexed company URL: Precision AI Pty, Ltd.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30319144853031914485PRECISION AI PTY LTD1N2026-01-01Suite 18 36 Agnes Street, Fortitude Valley Brisbane Queensland AU 4006

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3308081449561624K243955Precision AI Surgical Planning System (PAI-SPS)QHE2025-01-21
3308081754007403K233992Precision AI Surgical Planning System (PAI-SPS)QHE2024-08-05

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QHE22025-01-21

PMN#