FDA.reportPublic FDA data

QLARITY IMAGING

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30155293513015529351QLARITY IMAGING1N2020-04-25330 N Wabash Suite 3500 Chicago IL US 60611

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2315151285306492K191959QuantX Breast MRI Biopsy Guidance PluginLLZ2019-11-08
2315151218993668K170195QuantXLLZ2017-05-17
2315151222067503DEN170022QuantXPOK2017-07-19

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LLZ22019-11-08
POK12017-07-19

PMN#