Konica Minolta Healthcare Americas, Inc

Matched from indexed company URL: KONICA CORP.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1064396	3002885429	Konica Minolta Healthcare Americas, Inc	1	Y	2026-01-01	2217 Us Highway 70 E Garner NC US 27529
2241281	2241281	Konica Minolta Healthcare Americas, Inc.	1	Y	2026-01-01	411 Newark Pompton Tpke WAYNE NJ US 07470
3005406110	3005406110	KONICA MINOLTA TECHNOPRODUCTS CO., LTD.	1	N	2026-01-01	2-2-1 HIROSEDAI SAYAMA-SHI Saitama JP 350-1328

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
14774	1671358207	K250665	SKR 3000	MQB	2025-06-17
14774	1848490445	K241319	SKR 3000	MQB	2024-11-21
14774	1217902471	K240281	Bone Suppression Software	LLZ	2024-05-31
14774	1902279592	K230906	Konicaminolta DI-X1	LLZ	2023-04-25
14774	1724505670	K223267	SKR 3000	MQB	2022-11-17
202527	1191396946	K221853	OTC DDR	KPR	2022-07-27
14774	1590345907	K220993	Ultrasound System SONIMAGE MX1	IYN	2022-06-23
202527	1515344587	K214012	Straight Arm DDR	KPR	2022-01-12
14774	1419508204	K213908	SKR 3000	MQB	2022-01-31
14774	1117131008	K212685	KONICAMINOLTA DI-X1	LLZ	2021-09-13
14774	1042977524	K210619	SKR 3000	MQB	2021-08-24
14774	1632719646	K210066	ImagePilot	LLZ	2021-05-06
202527	2065710603	K193225	KDR AU-DDR System Advanced U-Arm with Dynamic Digital Radiography, KDR AU System Advanced U-Arm with Static Digital Radiography	KPR	2020-01-15
14774	1848599564	K182688	SKR 3000	MQB	2018-12-18
14774	2068907025	K182431	Konicaminolta DI-X1	LLZ	2018-11-26
14774	1597102132	K182153	Ultrasound System SONIMAGE HS1	IYO	2018-09-06
14774	1108929442	K180084	Ultrasound System SONIMAGE MX1	IYO	2018-02-08
14774	1195564325	K172793	SKR 3000	MQB	2017-10-12
14774	1423374187	K171716	SKR 3000	MQB	2017-08-25
14774	1278154475	K162504	SKR 3000	MQB	2016-10-03
14774	2018825458	K162065	Ultrasound System SONIMAGE HS1	IYN	2016-10-19
202527	1685396091	K160810	ViZion DR + Wireless	MQB	2016-05-20
14774	2034810844	K152577	ULTRASOUND SYSTEM SONIMAGE HS 1	IYN	2015-10-08
202527	1235510394	K152279	ViZion DR + Wireless	MQB	2015-09-10
14774	1928904768	K151465	AeroDR SYSTEM 2	MQB	2015-06-29
14774	1654329710	K151060	Ultrasound System SONIMAGE HS1	IYO	2015-06-05
202527	1129198056	K142919	EXA	LLZ	2014-12-16
14774	1381210594	K142197	ULTRASOUND SYSTEM SONIMAGE HS1, LINEAR PROBE L18-4, CONVEX PROBE C5-2	IYN	2014-11-21
14774	1012796765	K141459	APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM, V5.0	IYN	2014-10-28
14774	1357418519	K141271	AERODR SYSTEM 2	MQB	2014-09-26
14774	1245617738	K133730	CO PILOT/REGIUS UNITEA	LLZ	2014-01-31
202527	1426821764	K133139	VIZION ULTRA	MQB	2014-04-03
14774	1477195695	K131527	LOGIQ S8	IYN	2013-08-26
14774	1101776524	K130936	AERODR SYSTEM WITH P-31	MQB	2013-08-22
202527	1575307927	K123644	VIZION + DR	MQB	2013-01-11
14774	1600947822	K123499	AEROPILOT	MQB	2012-12-20
14774	1108003485	K122491	VIAMO SSA-640A V4.0	IYN	2012-09-13
14774	1037671963	K120752	AERODR STITCHING SYSTEM	KPR	2012-06-08
14774	1472333601	K120477	AEROSYNC FOR AERODR SYSTEM	MQB	2012-04-09
14774	2015033834	K120131	REGIUS SIGMA2	MQB	2012-02-10
14774	1585556569	K113248	AERODR SYSTEM WITH P-21	KPR	2012-01-17
202527	1003173468	K112661	VIZION DR	MQB	2011-10-20
14774	1644269549	K110717	KONICA MINOLTA XPRESS DIGITAL MAMMOGRAPHY SYSTEM	MUE	2011-12-23
14774	1601633909	K103703	REGUIS SIGMA	MQB	2011-06-02
14774	1401301810	K102349	AERODR SYSTEM	KPR	2010-11-24
202527	1600309982	K102123	VIZION DR	KPR	2011-01-24
14774	1296261910	K101842	ACIES	LLZ	2011-02-04
14774	1478969647	K092717	DIRECT DIGITIZER, REGIUS MODEL 210	MQB	2009-10-30
202527	1524892614	K091752	VIZTEK WL	KPR	2009-11-12
202527	1775919750	K082604	VIZTEK DR, MODELS: DR1000, DR3000, DR4000	KPR	2008-11-21
14774	1327191938	K081637	LASER IMAGER DRYPRO MODEL 873	LMC	2008-07-01
14774	1734843886	K071436	REGIUS UNITEA	LLZ	2007-06-27
14774	1960339300	K071181	DIRECT DIGITIZER, REGIUS MODEL 110	MQB	2007-05-30
202527	1292040197	K063337	OPAL-RAD	LLZ	2006-12-12
14774	1704863824	K061999	DRY LASER IMAGER, DRYPRO MODEL 832	LMC	2006-08-15
14774	1708287881	K051523	REGIUS CONSOLE CS-2000 AND REGIUS CONSOLE CS-3000, MEDICAL IMAGE PROCESSING WORKSTATION	LLZ	2005-07-20
202527	1061679034	K003607	ONYX-RAD TELEMEDICINE PACS	LLZ	2001-02-15
14774	1059674517
14774	1204565726
14774	1236549767
14774	1273103824
14774	1274995643
14774	1381312547
14774	1394317153
14774	1416966786
14774	1456335559
14774	1549176673
14774	1618029432
14774	1626533362
14774	1687447081
14774	1718217944
14774	1745117066
14774	1824344769
14774	1886560924
14774	1908778233
14774	1931209825
14774	1943833844
14774	2023832733
14774	2072559253

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
MQB	23	2025-06-17
LLZ	12	2024-05-31
KPR	9	2022-07-27
IYN	7	2022-06-23
IYO	3	2018-09-06
LMC	2	2008-07-01
MUE	1	2011-12-23

PMN#

SKR 3000
2024-11-21
Konica Minolta, Inc.
Bone Suppression Software
2024-05-31
Konica Minolta, Inc.
Konicaminolta DI-X1
2023-04-25
Konica Minolta, Inc.
SKR 3000
2022-11-17
Konica Minolta, INC.
OTC DDR
2022-07-27
Konica Minolta Healthcare Americas, Inc
Ultrasound System SONIMAGE MX1
2022-06-23
Konica Minolta, INC.
SKR 3000
2022-01-31
Konica Minolta, INC.
Universal DR 1748
2022-01-21
Konica Minolta Healthcare Americas, Inc.
Straight Arm DDR
2022-01-12
Konica Minolta Healthcare Americas, Inc
EXA
2021-12-10
Konica Minolta Healthcare Americas, Inc.
KONICAMINOLTA DI-X1
2021-09-13
Konica Minolta, Inc.
SKR 3000
2021-08-24
Konica Minolta, Inc.
ImagePilot
2021-05-06
Konica Minolta, Inc.
KDR AU-DDR System Advanced U-Arm With Dynamic Digital Radiography, KDR AU System Advanced U-Arm With Static Digital Radiography
2020-01-15
Konica Minolta Healthcare Americas, Inc
SKR 4000
2019-08-16
Konica Minolta, Inc.
SKR 3000
2018-12-18
KONICA MINOLTA, INC.
Konicaminolta DI-X1
2018-11-26
Konica Minolta, Inc.
Ultrasound System SONIMAGE HS1
2018-09-06
KONICA MINOLTA, INC.
Ultrasound System SONIMAGE MX1
2018-02-08
Konica Minolta, Inc.
SKR 3000
2017-10-12
KONICA MINOLTA, INC.
SKR 3000
2017-08-25
Konica Minolta, Inc.
Ultrasound System SONIMAGE HS1
2016-10-19
KONICA MINOLTA, INC.
SKR 3000
2016-10-03
KONICA MINOLTA, INC
ULTRASOUND SYSTEM SONIMAGE HS 1
2015-10-08
KONICA MINOLTA, INC.
AeroDR SYSTEM 2
2015-06-29
KONICA MINOLTA, INC.
Ultrasound System SONIMAGE HS1
2015-06-05
KONICA MINOLTA, INC.
ULTRASOUND SYSTEM SONIMAGE HS1, LINEAR PROBE L18-4, CONVEX PROBE C5-2
2014-11-21
KONICA MINOLTA INC.
AERODR SYSTEM 2
2014-09-26
KONICA MINOLTA, INC.
CO PILOT/REGIUS UNITEA
2014-01-31
KONICA MINOLTA INC.
AERODR SYSTEM WITH P-31
2013-08-22
KONICA MINOLTA MEDICAL & GRAPHIC, INC.
AEROPILOT
2012-12-20
KONICA MINOLTA MEDICAL & GRAPHIC, INC.
AERODR STITCHING SYSTEM
2012-06-08
KONICA MINOLTA MEDICAL & GRAPHIC, INC.
AERODR X70
2012-05-23
KONICA MINOLTA MEDICAL & GRAPHIC, INC.
AEROSYNC FOR AERODR SYSTEM
2012-04-09
KONICA MINOLTA MEDICAL & GRAPHIC, INC.
REGIUS SIGMA2
2012-02-10
KONICA MINOLTA MEDICAL & GRAPHIC, INC.
AERODR SYSTEM WITH P-21
2012-01-17
KONICA MINOLTA MEDICAL & GRAPHIC, INC.
KONICA MINOLTA XPRESS DIGITAL MAMMOGRAPHY SYSTEM
2011-12-23
KONICA MINOLTA MEDICAL & GRAPHIC, INC.
REGUIS SIGMA
2011-06-02
KONICA MINOLTA MEDICAL & GRAPHIC, INC.
ACIES
2011-02-04
KONICA MINOLTA MEDICAL & GRAPHIC, INC.
AERODR SYSTEM
2010-11-24
KONICA MINOLTA MEDICAL & GRAPHIC, INC.

73 records. Showing 1-40. Next

GUDID#

ImagePilot - D9MA
KONICA MINOLTA, INC.
2016-09-19
ImagePilot - V1.92R00E
KONICA MINOLTA, INC.
2021-08-31
ImagePilot - V1.93R00E
KONICA MINOLTA, INC.
2021-11-06
ImagePilot - V1.94R00E
KONICA MINOLTA, INC.
2022-03-03
ImagePilot - V1.95
KONICA MINOLTA, INC.
2023-07-19
Bone Suppression Software - AEVM
KONICA MINOLTA, INC.
2024-07-08
ImagePilot - V1.96R01E
KONICA MINOLTA, INC.
2026-04-24
KONICAMINOLTA DI-X1 - AD1D
KONICA MINOLTA, INC.
2026-03-25
P-53 - AEA1
KONICA MINOLTA, INC.
2024-12-06
P-53 - AEA0
KONICA MINOLTA, INC.
2024-12-06
P-61 - A9YC
KONICA MINOLTA, INC.
2017-01-04
P-61 - A8CE
KONICA MINOLTA, INC.
2017-01-04
KDR DDR Primary U Arm - KDR Primary U-Arm System with Dynamic Digital Radiography
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
2025-07-30
KDR Floor Mount System - KDR Floor Mount (Legacy proprietary name: VIZTEK DR, MODELS: DR1000, DR3000, DR4000)
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
2026-01-08
KDR Floor Mount+ System - KDR FMT+
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
2026-01-08
DRYPRO SD-QM2 - MEDICAL IMAGING FILM
KONICA MINOLTA, INC.
2025-05-22
DRYPRO SD-QM2 - MEDICAL IMAGING FILM
KONICA MINOLTA, INC.
2025-05-22
DRYPRO SD-QM2 - MEDICAL IMAGING FILM
KONICA MINOLTA, INC.
2025-05-22
CS-7 - AEVE
KONICA MINOLTA, INC.
2025-04-14
CS-7 - AEVD
KONICA MINOLTA, INC.
2024-12-06
KONICAMINOLTA DI-X1 - AEYC
KONICA MINOLTA, INC.
2024-10-07
REGIUS MODEL 110HQ - A5RF
KONICA MINOLTA, INC.
2016-09-19
REGIUS MODEL 110 - A5RE
KONICA MINOLTA, INC.
2016-09-19
REGIUS MODEL 110 - A5RD
KONICA MINOLTA, INC.
2016-09-19
REGIUS MODEL SIGMA2 - A5EU
KONICA MINOLTA, INC.
2016-09-19
REGIUS MODEL SIGMA2 - A5ET
KONICA MINOLTA, INC.
2016-09-19
REGIUS MODEL SIGMA2 - A5ER
KONICA MINOLTA, INC.
2016-09-19
REGIUS MODEL SIGMA - A1P8
KONICA MINOLTA, INC.
2016-09-19
REGIUS MODEL SIGMA - A1P6
KONICA MINOLTA, INC.
2016-09-19
REGIUS MODEL 110HQ - A1YC
KONICA MINOLTA, INC.
2016-09-19
REGIUS MODEL 210 - A1YD
KONICA MINOLTA, INC.
2016-09-19
REGIUS MODEL 110 - JFF7
KONICA MINOLTA, INC.
2016-09-19
14X17 Cassette for CR Reader - CRF-CASSETTE-35X43-R
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
2016-10-05
10X12 Cassette for CR Reader - 10X12 Cassette for CR Reader - R
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
2016-10-05
CR Reader - CR Reader-R
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
2016-09-24
CR Reader - AF CR Reader-R
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
2016-09-24
REGIUS Cassette - A1PH
KONICA MINOLTA, INC.
2016-09-19
REGIUS Cassette - A1PG
KONICA MINOLTA, INC.
2016-09-19
REGIUS Cassette - A1PJ
KONICA MINOLTA, INC.
2016-10-19
REGIUS Cassette - A3P6
KONICA MINOLTA, INC.
2016-09-19

80 records. Showing 1-40. Next