FDA.reportPublic FDA data

Jan Maniscalco

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30037691203003769120Jan Maniscalco1N2026-01-01411 Newark Pompton Turnpike Wayne NJ US 07470
30044856753004485675Jan Maniscalco1N2026-01-01411 Newark Pompton Turnpike Wayne NJ US 07470

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
147751059674517K946179SIEMENS SONOLINE 4XXIYO1995-10-03
147751671358207K250665SKR 3000MQB2025-06-17
147731671358207K250665SKR 3000MQB2025-06-17
147751848490445K241319SKR 3000MQB2024-11-21
147731848490445K241319SKR 3000MQB2024-11-21
147751217902471K240281Bone Suppression SoftwareLLZ2024-05-31
147731217902471K240281Bone Suppression SoftwareLLZ2024-05-31
147731902279592K230906Konicaminolta DI-X1LLZ2023-04-25
147751902279592K230906Konicaminolta DI-X1LLZ2023-04-25
147751724505670K223267SKR 3000MQB2022-11-17
147731724505670K223267SKR 3000MQB2022-11-17
147751590345907K220993Ultrasound System SONIMAGE MX1IYN2022-06-23
147751419508204K213908SKR 3000MQB2022-01-31
147731419508204K213908SKR 3000MQB2022-01-31
147751117131008K212685KONICAMINOLTA DI-X1LLZ2021-09-13
147731117131008K212685KONICAMINOLTA DI-X1LLZ2021-09-13
147751042977524K210619SKR 3000MQB2021-08-24
147731042977524K210619SKR 3000MQB2021-08-24
147751632719646K210066ImagePilotLLZ2021-05-06
147751032109945K191645SKR 4000MQB2019-08-16
147731032109945K191645SKR 4000MQB2019-08-16
147751848599564K182688SKR 3000MQB2018-12-18
147731848599564K182688SKR 3000MQB2018-12-18
147752068907025K182431Konicaminolta DI-X1LLZ2018-11-26
147732068907025K182431Konicaminolta DI-X1LLZ2018-11-26
147751597102132K182153Ultrasound System SONIMAGE HS1IYO2018-09-06
147751108929442K180084Ultrasound System SONIMAGE MX1IYO2018-02-08
147751626533362K180067ACUSON X800 Diagnostic Ultrasound SystemIYN2018-02-07
147751273103824K180039ACUSON P600 Diagnostic Ultrasound SystemIYN2018-02-01
147731195564325K172793SKR 3000MQB2017-10-12
147751195564325K172793SKR 3000MQB2017-10-12
147731423374187K171716SKR 3000MQB2017-08-25
147751423374187K171716SKR 3000MQB2017-08-25
147731278154475K162504SKR 3000MQB2016-10-03
147751278154475K162504SKR 3000MQB2016-10-03
147752018825458K162065Ultrasound System SONIMAGE HS1IYN2016-10-19
147752034810844K152577ULTRASOUND SYSTEM SONIMAGE HS 1IYN2015-10-08
147731928904768K151465AeroDR SYSTEM 2MQB2015-06-29
147751928904768K151465AeroDR SYSTEM 2MQB2015-06-29
147751654329710K151060Ultrasound System SONIMAGE HS1IYO2015-06-05
147751381210594K142197ULTRASOUND SYSTEM SONIMAGE HS1, LINEAR PROBE L18-4, CONVEX PROBE C5-2IYN2014-11-21
147751745117066K141846ACUSON X700 ULTRASOUND SYSTEM, ACUSON X600 ULTRASOUND SYSTEMIYN2014-08-07
147751012796765K141459APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM, V5.0IYN2014-10-28
147751357418519K141271AERODR SYSTEM 2MQB2014-09-26
147731357418519K141271AERODR SYSTEM 2MQB2014-09-26
147751245617738K133730CO PILOT/REGIUS UNITEALLZ2014-01-31
147751824344769K132804ACUSON S1000 / S2000 / S3000IYN2013-10-24
147751477195695K131527LOGIQ S8IYN2013-08-26
147751101776524K130936AERODR SYSTEM WITH P-31MQB2013-08-22
147731101776524K130936AERODR SYSTEM WITH P-31MQB2013-08-22
147751600947822K123499AEROPILOTMQB2012-12-20
147751108003485K122491VIAMO SSA-640A V4.0IYN2012-09-13
147751456335559K121699ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM SONOVISTA X300 DIAGNOSTIC ULTRASOUND SYSTEMIYN2012-06-22
147751687447081K121646ACUSON X150 DIAGNOSTIC ULTRASOUND SYSTEM SONOVISTA X150 DIAGNOSTIC ULTRASOUND SYSTEMIYN2012-06-22
147751643305944K121109AERODR X70KPR2012-05-23
147731037671963K120752AERODR STITCHING SYSTEMKPR2012-06-08
147751037671963K120752AERODR STITCHING SYSTEMKPR2012-06-08
147751472333601K120477AEROSYNC FOR AERODR SYSTEMMQB2012-04-09
147731472333601K120477AEROSYNC FOR AERODR SYSTEMMQB2012-04-09
147732015033834K120131REGIUS SIGMA2MQB2012-02-10
147752015033834K120131REGIUS SIGMA2MQB2012-02-10
147731585556569K113248AERODR SYSTEM WITH P-21KPR2012-01-17
147751585556569K113248AERODR SYSTEM WITH P-21KPR2012-01-17
147751644269549K110717KONICA MINOLTA XPRESS DIGITAL MAMMOGRAPHY SYSTEMMUE2011-12-23
147731644269549K110717KONICA MINOLTA XPRESS DIGITAL MAMMOGRAPHY SYSTEMMUE2011-12-23
147731601633909K103703REGUIS SIGMAMQB2011-06-02
147751601633909K103703REGUIS SIGMAMQB2011-06-02
147731401301810K102349AERODR SYSTEMKPR2010-11-24
147751401301810K102349AERODR SYSTEMKPR2010-11-24
147751296261910K101842ACIESLLZ2011-02-04
147731478969647K092717DIRECT DIGITIZER, REGIUS MODEL 210MQB2009-10-30
147751478969647K092717DIRECT DIGITIZER, REGIUS MODEL 210MQB2009-10-30
147751327191938K081637LASER IMAGER DRYPRO MODEL 873LMC2008-07-01
147731327191938K081637LASER IMAGER DRYPRO MODEL 873LMC2008-07-01
147751734843886K071436REGIUS UNITEALLZ2007-06-27
147751381312547K071314SONOLINE G20 DIAGNOSTIC ULTRASOUND SYSTEMSIYO2007-05-22
147731960339300K071181DIRECT DIGITIZER, REGIUS MODEL 110MQB2007-05-30
147751960339300K071181DIRECT DIGITIZER, REGIUS MODEL 110MQB2007-05-30
147751618029432K063803ACUSON ANTARES DIAGNOSTIC ULTRASOUND SYSTEMIYN2007-01-05
147731704863824K061999DRY LASER IMAGER, DRYPRO MODEL 832LMC2006-08-15
147751704863824K061999DRY LASER IMAGER, DRYPRO MODEL 832LMC2006-08-15
147751394317153K052894SONOLINE G60 S ULTRASOUND SYSTEMIYN2005-11-23
147751708287881K051523REGIUS CONSOLE CS-2000 AND REGIUS CONSOLE CS-3000, MEDICAL IMAGE PROCESSING WORKSTATIONLLZ2005-07-20
147731708287881K051523REGIUS CONSOLE CS-2000 AND REGIUS CONSOLE CS-3000, MEDICAL IMAGE PROCESSING WORKSTATIONLLZ2005-07-20
147731204565726
147751204565726
147751632097319
147751954963092

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MQB372025-06-17
IYN152022-06-23
LLZ142024-05-31
KPR72012-06-08
IYO52018-09-06
LMC42008-07-01
MUE22011-12-23