KONICA MINOLTA, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3004485675	3004485675	KONICA MINOLTA, INC.	1	N	2026-01-01	1 SAKURA-MACHI HINO-SHI Tokyo JP 191-8511

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
14775	1059674517	K946179	SIEMENS SONOLINE 4XX	IYO	1995-10-03
14775	1671358207	K250665	SKR 3000	MQB	2025-06-17
14775	1848490445	K241319	SKR 3000	MQB	2024-11-21
14775	1217902471	K240281	Bone Suppression Software	LLZ	2024-05-31
14775	1902279592	K230906	Konicaminolta DI-X1	LLZ	2023-04-25
14775	1724505670	K223267	SKR 3000	MQB	2022-11-17
14775	1590345907	K220993	Ultrasound System SONIMAGE MX1	IYN	2022-06-23
14775	1419508204	K213908	SKR 3000	MQB	2022-01-31
14775	1117131008	K212685	KONICAMINOLTA DI-X1	LLZ	2021-09-13
14775	1042977524	K210619	SKR 3000	MQB	2021-08-24
14775	1632719646	K210066	ImagePilot	LLZ	2021-05-06
14775	1032109945	K191645	SKR 4000	MQB	2019-08-16
14775	1848599564	K182688	SKR 3000	MQB	2018-12-18
14775	2068907025	K182431	Konicaminolta DI-X1	LLZ	2018-11-26
14775	1597102132	K182153	Ultrasound System SONIMAGE HS1	IYO	2018-09-06
14775	1108929442	K180084	Ultrasound System SONIMAGE MX1	IYO	2018-02-08
14775	1626533362	K180067	ACUSON X800 Diagnostic Ultrasound System	IYN	2018-02-07
14775	1273103824	K180039	ACUSON P600 Diagnostic Ultrasound System	IYN	2018-02-01
14775	1195564325	K172793	SKR 3000	MQB	2017-10-12
14775	1423374187	K171716	SKR 3000	MQB	2017-08-25
14775	1278154475	K162504	SKR 3000	MQB	2016-10-03
14775	2018825458	K162065	Ultrasound System SONIMAGE HS1	IYN	2016-10-19
14775	2034810844	K152577	ULTRASOUND SYSTEM SONIMAGE HS 1	IYN	2015-10-08
14775	1928904768	K151465	AeroDR SYSTEM 2	MQB	2015-06-29
14775	1654329710	K151060	Ultrasound System SONIMAGE HS1	IYO	2015-06-05
14775	1381210594	K142197	ULTRASOUND SYSTEM SONIMAGE HS1, LINEAR PROBE L18-4, CONVEX PROBE C5-2	IYN	2014-11-21
14775	1745117066	K141846	ACUSON X700 ULTRASOUND SYSTEM, ACUSON X600 ULTRASOUND SYSTEM	IYN	2014-08-07
14775	1012796765	K141459	APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM, V5.0	IYN	2014-10-28
14775	1357418519	K141271	AERODR SYSTEM 2	MQB	2014-09-26
14775	1245617738	K133730	CO PILOT/REGIUS UNITEA	LLZ	2014-01-31
14775	1824344769	K132804	ACUSON S1000 / S2000 / S3000	IYN	2013-10-24
14775	1477195695	K131527	LOGIQ S8	IYN	2013-08-26
14775	1101776524	K130936	AERODR SYSTEM WITH P-31	MQB	2013-08-22
14775	1600947822	K123499	AEROPILOT	MQB	2012-12-20
14775	1108003485	K122491	VIAMO SSA-640A V4.0	IYN	2012-09-13
14775	1456335559	K121699	ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM SONOVISTA X300 DIAGNOSTIC ULTRASOUND SYSTEM	IYN	2012-06-22
14775	1687447081	K121646	ACUSON X150 DIAGNOSTIC ULTRASOUND SYSTEM SONOVISTA X150 DIAGNOSTIC ULTRASOUND SYSTEM	IYN	2012-06-22
14775	1643305944	K121109	AERODR X70	KPR	2012-05-23
14775	1037671963	K120752	AERODR STITCHING SYSTEM	KPR	2012-06-08
14775	1472333601	K120477	AEROSYNC FOR AERODR SYSTEM	MQB	2012-04-09
14775	2015033834	K120131	REGIUS SIGMA2	MQB	2012-02-10
14775	1585556569	K113248	AERODR SYSTEM WITH P-21	KPR	2012-01-17
14775	1644269549	K110717	KONICA MINOLTA XPRESS DIGITAL MAMMOGRAPHY SYSTEM	MUE	2011-12-23
14775	1601633909	K103703	REGUIS SIGMA	MQB	2011-06-02
14775	1401301810	K102349	AERODR SYSTEM	KPR	2010-11-24
14775	1296261910	K101842	ACIES	LLZ	2011-02-04
14775	1478969647	K092717	DIRECT DIGITIZER, REGIUS MODEL 210	MQB	2009-10-30
14775	1327191938	K081637	LASER IMAGER DRYPRO MODEL 873	LMC	2008-07-01
14775	1734843886	K071436	REGIUS UNITEA	LLZ	2007-06-27
14775	1381312547	K071314	SONOLINE G20 DIAGNOSTIC ULTRASOUND SYSTEMS	IYO	2007-05-22
14775	1960339300	K071181	DIRECT DIGITIZER, REGIUS MODEL 110	MQB	2007-05-30
14775	1618029432	K063803	ACUSON ANTARES DIAGNOSTIC ULTRASOUND SYSTEM	IYN	2007-01-05
14775	1704863824	K061999	DRY LASER IMAGER, DRYPRO MODEL 832	LMC	2006-08-15
14775	1394317153	K052894	SONOLINE G60 S ULTRASOUND SYSTEM	IYN	2005-11-23
14775	1708287881	K051523	REGIUS CONSOLE CS-2000 AND REGIUS CONSOLE CS-3000, MEDICAL IMAGE PROCESSING WORKSTATION	LLZ	2005-07-20
14775	1204565726
14775	1632097319
14775	1954963092

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
MQB	19	2025-06-17
IYN	15	2022-06-23
LLZ	9	2024-05-31
IYO	5	2018-09-06
KPR	4	2012-06-08
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.
Ultrasound System SONIMAGE MX1
2022-06-23
Konica Minolta, INC.
SKR 3000
2022-01-31
Konica Minolta, 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.
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.
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.
AERODR SYSTEM 2
2014-09-26
KONICA MINOLTA, INC.

GUDID#

ImagePilot - V1.96R01E
KONICA MINOLTA, INC.
2026-04-24
Bone Suppression Software - AEVM
KONICA MINOLTA, INC.
2024-07-08
ImagePilot - V1.95
KONICA MINOLTA, INC.
2023-07-19
ImagePilot - V1.94R00E
KONICA MINOLTA, INC.
2022-03-03
ImagePilot - V1.93R00E
KONICA MINOLTA, INC.
2021-11-06
ImagePilot - V1.92R00E
KONICA MINOLTA, INC.
2021-08-31
ImagePilot - D9MA
KONICA MINOLTA, INC.
2016-09-19
KONICAMINOLTA DI-X1 - AD1D
KONICA MINOLTA, INC.
2026-03-25
P-53 - AEA0
KONICA MINOLTA, INC.
2024-12-06
P-53 - AEA1
KONICA MINOLTA, INC.
2024-12-06
P-61 - A8CE
KONICA MINOLTA, INC.
2017-01-04
P-61 - A9YC
KONICA MINOLTA, INC.
2017-01-04
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 110 - JFF7
KONICA MINOLTA, INC.
2016-09-19
REGIUS MODEL 210 - A1YD
KONICA MINOLTA, INC.
2016-09-19
REGIUS MODEL 110HQ - A1YC
KONICA MINOLTA, INC.
2016-09-19
REGIUS MODEL SIGMA - A1P6
KONICA MINOLTA, INC.
2016-09-19
REGIUS MODEL SIGMA - A1P8
KONICA MINOLTA, INC.
2016-09-19
REGIUS MODEL SIGMA2 - A5ER
KONICA MINOLTA, INC.
2016-09-19
REGIUS MODEL SIGMA2 - A5ET
KONICA MINOLTA, INC.
2016-09-19
REGIUS MODEL SIGMA2 - A5EU
KONICA MINOLTA, INC.
2016-09-19
REGIUS MODEL 110 - A5RD
KONICA MINOLTA, INC.
2016-09-19
REGIUS MODEL 110 - A5RE
KONICA MINOLTA, INC.
2016-09-19
REGIUS MODEL 110HQ - A5RF
KONICA MINOLTA, INC.
2016-09-19
REGIUS Cassette/Plate - KCKD
KONICA MINOLTA, INC.
2016-09-19
REGIUS Cassette/Plate - KCPJ
KONICA MINOLTA, INC.
2016-09-19
REGIUS Cassette/Plate - KCLU
KONICA MINOLTA, INC.
2016-09-19
REGIUS Cassette/Plate - BUN2
KONICA MINOLTA, INC.
2016-09-19
REGIUS Cassette/Plate - JFJ8
KONICA MINOLTA, INC.
2016-09-19
REGIUS Cassette - A2TC
KONICA MINOLTA, INC.
2016-09-19
REGIUS Cassette - A2VX
KONICA MINOLTA, INC.
2016-09-19
REGIUS Cassette - A1GU
KONICA MINOLTA, INC.
2016-09-19
REGIUS Cassette - A2NE
KONICA MINOLTA, INC.
2016-09-19
REGIUS Cassette - A2RS
KONICA MINOLTA, INC.
2016-09-19
REGIUS Cassette - E2E3
KONICA MINOLTA, INC.
2016-09-19

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