FDA.reportPublic FDA data

Exo Imaging, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30174878053017487805Exo Imaging, Inc.1N2026-01-014201 Burton Drive Santa Clara CA US 95054

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3053731245462776K242359Strain AI (SAI001)QIH2024-11-20
3053731810823854K240953AI Platform 2.0 (AIP002)QIH2024-08-05
3053731127251526K232501AI Platform (AIP001)QIH2023-11-17
3053731788209203K230497Bladder AI (AIBV01)QIH2023-06-22
3053731730165500K222198Exo Iris (El2001)IYN2022-11-09
3053731543084349

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QIH42024-11-20
IYN12022-11-09

PMN#

GUDID#