FDA.reportPublic FDA data

HOLOGIC, INC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
29536903001632635HOLOGIC, INC1N2020-04-252520 Mission College Blvd. Suite 202 Santa Clara CA US 95054

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
141232040648580P970058M1000 IMAGECHECKERMYN1998-06-26
141231303959078K091368R2 DIGITALNOW HD(DIGITALNOW HD)LLZ2009-06-04
141231556184694K051743R2 BREAST IMAGING WORKSTATIONLLZ2005-07-25
141231421554610K050667R2 FAMILY OF IMAGE DISPLAY UNITS WITH R2 UNIFORM DISPLAY SOFTWARELLZ2005-03-29
141231929393256K023003IMAGECHECKER-CT WORKSTATIONLLZ2002-11-20

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LLZ42009-06-04
MYN 11998-06-26

PMN#