FDA.reportPublic FDA data

Konica Minolta Healthcare Americas, Inc

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10643963002885429Konica Minolta Healthcare Americas, Inc1Y2026-01-012217 Us Highway 70 E Garner NC US 27529

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2025271926629114K252996Universal 1417PIMQB2026-06-12
2025271191396946K221853OTC DDRKPR2022-07-27
2025271515344587K214012Straight Arm DDRKPR2022-01-12
2025272065710603K193225KDR AU-DDR System Advanced U-Arm with Dynamic Digital Radiography, KDR AU System Advanced U-Arm with Static Digital RadiographyKPR2020-01-15
2025271685396091K160810ViZion DR + WirelessMQB2016-05-20
2025271235510394K152279ViZion DR + WirelessMQB2015-09-10
2025271129198056K142919EXALLZ2014-12-16
2025271426821764K133139VIZION ULTRAMQB2014-04-03
2025271575307927K123644VIZION + DRMQB2013-01-11
2025271003173468K112661VIZION DRMQB2011-10-20
2025271600309982K102123VIZION DRKPR2011-01-24
2025271524892614K091752VIZTEK WLKPR2009-11-12
2025271775919750K082604VIZTEK DR, MODELS: DR1000, DR3000, DR4000KPR2008-11-21
2025271292040197K063337OPAL-RADLLZ2006-12-12
2025271061679034K003607ONYX-RAD TELEMEDICINE PACSLLZ2001-02-15

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MQB62026-06-12
KPR62022-07-27
LLZ32014-12-16

PMN#