FDA.report

Jan Maniscalco

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30037691203003769120Jan Maniscalco1N2026-01-01411 Newark Pompton Turnpike Wayne NJ US 07470

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
147731671358207K250665SKR 3000MQB2025-06-17
147731848490445K241319SKR 3000MQB2024-11-21
147731217902471K240281Bone Suppression SoftwareLLZ2024-05-31
147731902279592K230906Konicaminolta DI-X1LLZ2023-04-25
147731724505670K223267SKR 3000MQB2022-11-17
147731419508204K213908SKR 3000MQB2022-01-31
147731117131008K212685KONICAMINOLTA DI-X1LLZ2021-09-13
147731042977524K210619SKR 3000MQB2021-08-24
147731032109945K191645SKR 4000MQB2019-08-16
147731848599564K182688SKR 3000MQB2018-12-18
147732068907025K182431Konicaminolta DI-X1LLZ2018-11-26
147731195564325K172793SKR 3000MQB2017-10-12
147731423374187K171716SKR 3000MQB2017-08-25
147731278154475K162504SKR 3000MQB2016-10-03
147731928904768K151465AeroDR SYSTEM 2MQB2015-06-29
147731357418519K141271AERODR SYSTEM 2MQB2014-09-26
147731101776524K130936AERODR SYSTEM WITH P-31MQB2013-08-22
147731037671963K120752AERODR STITCHING SYSTEMKPR2012-06-08
147731472333601K120477AEROSYNC FOR AERODR SYSTEMMQB2012-04-09
147732015033834K120131REGIUS SIGMA2MQB2012-02-10
147731585556569K113248AERODR SYSTEM WITH P-21KPR2012-01-17
147731644269549K110717KONICA MINOLTA XPRESS DIGITAL MAMMOGRAPHY SYSTEMMUE2011-12-23
147731601633909K103703REGUIS SIGMAMQB2011-06-02
147731401301810K102349AERODR SYSTEMKPR2010-11-24
147731478969647K092717DIRECT DIGITIZER, REGIUS MODEL 210MQB2009-10-30
147731327191938K081637LASER IMAGER DRYPRO MODEL 873LMC2008-07-01
147731960339300K071181DIRECT DIGITIZER, REGIUS MODEL 110MQB2007-05-30
147731704863824K061999DRY LASER IMAGER, DRYPRO MODEL 832LMC2006-08-15
147731708287881K051523REGIUS CONSOLE CS-2000 AND REGIUS CONSOLE CS-3000, MEDICAL IMAGE PROCESSING WORKSTATIONLLZ2005-07-20
147731204565726

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
MQB182025-06-17
LLZ52024-05-31
KPR32012-06-08
LMC22008-07-01
MUE12011-12-23