FDA.report

Konica Minolta Healthcare Americas, Inc

Matched from indexed company URL: KONICA CORP.

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
10643963002885429Konica Minolta Healthcare Americas, Inc1Y2026-01-012217 Us Highway 70 E Garner NC US 27529
22412812241281Konica Minolta Healthcare Americas, Inc.1Y2026-01-01411 Newark Pompton Tpke WAYNE NJ US 07470
30044856753004485675KONICA MINOLTA, INC.1N2026-01-011 SAKURA-MACHI HINO-SHI Tokyo JP 191-8511
30054061103005406110KONICA MINOLTA TECHNOPRODUCTS CO., LTD.1N2026-01-012-2-1 HIROSEDAI SAYAMA-SHI Saitama JP 350-1328

GUDID Contact Samples

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDIDProductPhoneEmail
00817100020278KDR Floor Mount+ System - KDR FMT+833-562-2737KMHASupport@gcp.konicaminolta.com
00817100021282KDR Floor Mount System - KDR Floor Mount (Legacy proprietary name: VIZTEK DR, MODELS: DR1000, DR3000, DR4000)833-562-2737KMHASupport@gcp.konicaminolta.com

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
147751059674517K946179SIEMENS SONOLINE 4XXIYO1995-10-03
147741671358207K250665SKR 3000MQB2025-06-17
147751671358207K250665SKR 3000MQB2025-06-17
147741848490445K241319SKR 3000MQB2024-11-21
147751848490445K241319SKR 3000MQB2024-11-21
147741217902471K240281Bone Suppression SoftwareLLZ2024-05-31
147751217902471K240281Bone Suppression SoftwareLLZ2024-05-31
147741902279592K230906Konicaminolta DI-X1LLZ2023-04-25
147751902279592K230906Konicaminolta DI-X1LLZ2023-04-25
147741724505670K223267SKR 3000MQB2022-11-17
147751724505670K223267SKR 3000MQB2022-11-17
2025271191396946K221853OTC DDRKPR2022-07-27
147741590345907K220993Ultrasound System SONIMAGE MX1IYN2022-06-23
147751590345907K220993Ultrasound System SONIMAGE MX1IYN2022-06-23
2025271515344587K214012Straight Arm DDRKPR2022-01-12
147741419508204K213908SKR 3000MQB2022-01-31
147751419508204K213908SKR 3000MQB2022-01-31
147741117131008K212685KONICAMINOLTA DI-X1LLZ2021-09-13
147751117131008K212685KONICAMINOLTA DI-X1LLZ2021-09-13
147741042977524K210619SKR 3000MQB2021-08-24
147751042977524K210619SKR 3000MQB2021-08-24
147741632719646K210066ImagePilotLLZ2021-05-06
147751632719646K210066ImagePilotLLZ2021-05-06
2025272065710603K193225KDR AU-DDR System Advanced U-Arm with Dynamic Digital Radiography, KDR AU System Advanced U-Arm with Static Digital RadiographyKPR2020-01-15
147751032109945K191645SKR 4000MQB2019-08-16
147741848599564K182688SKR 3000MQB2018-12-18
147751848599564K182688SKR 3000MQB2018-12-18
147742068907025K182431Konicaminolta DI-X1LLZ2018-11-26
147752068907025K182431Konicaminolta DI-X1LLZ2018-11-26
147741597102132K182153Ultrasound System SONIMAGE HS1IYO2018-09-06
147751597102132K182153Ultrasound System SONIMAGE HS1IYO2018-09-06
147741108929442K180084Ultrasound System SONIMAGE MX1IYO2018-02-08
147751108929442K180084Ultrasound System SONIMAGE MX1IYO2018-02-08
147751626533362K180067ACUSON X800 Diagnostic Ultrasound SystemIYN2018-02-07
147751273103824K180039ACUSON P600 Diagnostic Ultrasound SystemIYN2018-02-01
147741195564325K172793SKR 3000MQB2017-10-12
147751195564325K172793SKR 3000MQB2017-10-12
147741423374187K171716SKR 3000MQB2017-08-25
147751423374187K171716SKR 3000MQB2017-08-25
147741278154475K162504SKR 3000MQB2016-10-03
147751278154475K162504SKR 3000MQB2016-10-03
147742018825458K162065Ultrasound System SONIMAGE HS1IYN2016-10-19
147752018825458K162065Ultrasound System SONIMAGE HS1IYN2016-10-19
2025271685396091K160810ViZion DR + WirelessMQB2016-05-20
147742034810844K152577ULTRASOUND SYSTEM SONIMAGE HS 1IYN2015-10-08
147752034810844K152577ULTRASOUND SYSTEM SONIMAGE HS 1IYN2015-10-08
2025271235510394K152279ViZion DR + WirelessMQB2015-09-10
147741928904768K151465AeroDR SYSTEM 2MQB2015-06-29
147751928904768K151465AeroDR SYSTEM 2MQB2015-06-29
147741654329710K151060Ultrasound System SONIMAGE HS1IYO2015-06-05
147751654329710K151060Ultrasound System SONIMAGE HS1IYO2015-06-05
2025271129198056K142919EXALLZ2014-12-16
147741381210594K142197ULTRASOUND SYSTEM SONIMAGE HS1, LINEAR PROBE L18-4, CONVEX PROBE C5-2IYN2014-11-21
147751381210594K142197ULTRASOUND SYSTEM SONIMAGE HS1, LINEAR PROBE L18-4, CONVEX PROBE C5-2IYN2014-11-21
147751745117066K141846ACUSON X700 ULTRASOUND SYSTEM, ACUSON X600 ULTRASOUND SYSTEMIYN2014-08-07
147741012796765K141459APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM, V5.0IYN2014-10-28
147751012796765K141459APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM, V5.0IYN2014-10-28
147741357418519K141271AERODR SYSTEM 2MQB2014-09-26
147751357418519K141271AERODR SYSTEM 2MQB2014-09-26
147741245617738K133730CO PILOT/REGIUS UNITEALLZ2014-01-31
147751245617738K133730CO PILOT/REGIUS UNITEALLZ2014-01-31
2025271426821764K133139VIZION ULTRAMQB2014-04-03
147751824344769K132804ACUSON S1000 / S2000 / S3000IYN2013-10-24
147741477195695K131527LOGIQ S8IYN2013-08-26
147751477195695K131527LOGIQ S8IYN2013-08-26
147741101776524K130936AERODR SYSTEM WITH P-31MQB2013-08-22
147751101776524K130936AERODR SYSTEM WITH P-31MQB2013-08-22
2025271575307927K123644VIZION + DRMQB2013-01-11
147741600947822K123499AEROPILOTMQB2012-12-20
147751600947822K123499AEROPILOTMQB2012-12-20
147741108003485K122491VIAMO SSA-640A V4.0IYN2012-09-13
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
147741037671963K120752AERODR STITCHING SYSTEMKPR2012-06-08
147751037671963K120752AERODR STITCHING SYSTEMKPR2012-06-08
147741472333601K120477AEROSYNC FOR AERODR SYSTEMMQB2012-04-09
147751472333601K120477AEROSYNC FOR AERODR SYSTEMMQB2012-04-09
147742015033834K120131REGIUS SIGMA2MQB2012-02-10
147752015033834K120131REGIUS SIGMA2MQB2012-02-10
147741585556569K113248AERODR SYSTEM WITH P-21KPR2012-01-17
147751585556569K113248AERODR SYSTEM WITH P-21KPR2012-01-17
2025271003173468K112661VIZION DRMQB2011-10-20
147741644269549K110717KONICA MINOLTA XPRESS DIGITAL MAMMOGRAPHY SYSTEMMUE2011-12-23
147751644269549K110717KONICA MINOLTA XPRESS DIGITAL MAMMOGRAPHY SYSTEMMUE2011-12-23
147741601633909K103703REGUIS SIGMAMQB2011-06-02
147751601633909K103703REGUIS SIGMAMQB2011-06-02
147741401301810K102349AERODR SYSTEMKPR2010-11-24
147751401301810K102349AERODR SYSTEMKPR2010-11-24
2025271600309982K102123VIZION DRKPR2011-01-24
147741296261910K101842ACIESLLZ2011-02-04
147751296261910K101842ACIESLLZ2011-02-04
147741478969647K092717DIRECT DIGITIZER, REGIUS MODEL 210MQB2009-10-30
147751478969647K092717DIRECT DIGITIZER, REGIUS MODEL 210MQB2009-10-30
2025271524892614K091752VIZTEK WLKPR2009-11-12
2025271775919750K082604VIZTEK DR, MODELS: DR1000, DR3000, DR4000KPR2008-11-21
147741327191938K081637LASER IMAGER DRYPRO MODEL 873LMC2008-07-01
147751327191938K081637LASER IMAGER DRYPRO MODEL 873LMC2008-07-01
147741734843886K071436REGIUS UNITEALLZ2007-06-27
147751734843886K071436REGIUS UNITEALLZ2007-06-27
147751381312547K071314SONOLINE G20 DIAGNOSTIC ULTRASOUND SYSTEMSIYO2007-05-22
147741960339300K071181DIRECT DIGITIZER, REGIUS MODEL 110MQB2007-05-30
147751960339300K071181DIRECT DIGITIZER, REGIUS MODEL 110MQB2007-05-30
147751618029432K063803ACUSON ANTARES DIAGNOSTIC ULTRASOUND SYSTEMIYN2007-01-05
2025271292040197K063337OPAL-RADLLZ2006-12-12
147741704863824K061999DRY LASER IMAGER, DRYPRO MODEL 832LMC2006-08-15
147751704863824K061999DRY LASER IMAGER, DRYPRO MODEL 832LMC2006-08-15
147751394317153K052894SONOLINE G60 S ULTRASOUND SYSTEMIYN2005-11-23
147741708287881K051523REGIUS CONSOLE CS-2000 AND REGIUS CONSOLE CS-3000, MEDICAL IMAGE PROCESSING WORKSTATIONLLZ2005-07-20
147751708287881K051523REGIUS CONSOLE CS-2000 AND REGIUS CONSOLE CS-3000, MEDICAL IMAGE PROCESSING WORKSTATIONLLZ2005-07-20
2025271061679034K003607ONYX-RAD TELEMEDICINE PACSLLZ2001-02-15
147741059674517
147741204565726
147751204565726
147741236549767
147741273103824
147741274995643
147741381312547
147741394317153

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
MQB422025-06-17
IYN222022-06-23
LLZ212024-05-31
KPR132022-07-27
IYO82018-09-06
LMC42008-07-01
MUE22011-12-23

PMN

OTC DDR

2022-07-27

Konica Minolta Healthcare Americas, Inc

EXA

2021-12-10

Konica Minolta Healthcare Americas, Inc.

AEROPILOT

2012-12-20

KONICA MINOLTA MEDICAL & GRAPHIC, INC.

AERODR X70

2012-05-23

KONICA MINOLTA MEDICAL & GRAPHIC, INC.

REGUIS SIGMA

2011-06-02

KONICA MINOLTA MEDICAL & GRAPHIC, INC.

ACIES

2011-02-04

KONICA MINOLTA MEDICAL & GRAPHIC, INC.

73 records. Showing 1-40. Next

GUDID

200 records. Showing 1-40. Next