FDA.reportPublic FDA data

EXACT IMAGING, INC.

Matched from indexed company URL: Exact Imaging, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30124028863012402886EXACT IMAGING, INC.1N2026-01-017676 Woodbine Avenue Unit 15 Markham Ontario CA L3R 2N2

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2033831657856969K990175SHEATHES (NON-LATEX), STERILEITX1999-04-21
2033832057512619K192303ExactVu High Resolution Micro-Ultrasound SystemIYN2019-10-01
2033831442420566K190995ExactVu High Resolution Micro-Ultrasound SystemIYN2019-05-10
2033831191435775K180636ExactVu High Resolution Micro-Ultrasound SystemIYO2018-04-30
2033832008263003K162972ExactVu High Resolution Micro-Ultrasound SystemIYO2016-12-02
2033831705044519

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
IYN22019-10-01
IYO22018-04-30
ITX11999-04-21

PMN#

GUDID#