KONICA MINOLTA TECHNOPRODUCTS CO., LTD.

FDA Device Registration & Listing · SAYAMA-SHI Saitama, JP · Registration 3005406110

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3005406110
FEI Number
3005406110
Entity Name
KONICA MINOLTA TECHNOPRODUCTS CO., LTD.
City/State/Country
SAYAMA-SHI Saitama, JP
Establishment Address
2-2-1 HIROSEDAI, SAYAMA-SHI Saitama 350-1328, JP
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
KONICA MINOLTA, INC. (Owner Number: 9009884)
Owner / Operator Contact Address
1 Sakura-machi, Hino-shi, JP-13 191-8511, JP
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K101842
PMA Number
N/A

All Registered Proprietary Names

REGIUS Cassette/Plate REGIUS Cassette REGIUS Plate REGIUS MODEL 110HQ REGIUS MODEL 110 KONICAMINOLTA DI-X1 AeroDR SYSTEM 2 CS-7 AeroDR P-52 Convex Probe C5-2 Linear Probe L11-3 Convex Probe MC10-3 Linear Probe L14-4 Ultrasound System SONIMAGE MX1 SKR 3000 P-61 CS-7 SKR 3000 CS-7 P-81 P-71 Ultrasound Transducer 11M3 Model 11284923 Convex Probe C5-2 Sector Probe S4-2 Convex Probe MC10-3 Linear Probe L14-4 Linear Probe L11-3 Ultrasound System SONIMAGE HS1 Endocavity Probe EC9-3 Linear Probe HL18-4 Ultrasound System SONIMAGE HS2 Linear Probe L18-4 AeroDR SYSTEM CS-7 AeroDR P-31 ImagePilot KONICAMINOLTA DI-X1 CS-7 SKR 3000 P-65 P-75 CS-7 G-59 SKR 3000 G-60 G-22 REGIUS Plate FP-1S REGIUS Cassette RC-300 REGIUS SIGMA2 Xpress Digital Mammography System Linear Probe HL18-4 Linear Probe L14-4 Convex Probe MC10-3 Sector Probe S4-2 Endocavity Probe EC9-3 Convex Probe C5-2 Linear Probe L11-3 Linear Probe L18-4 Ultrasound System SONIMAGE HS1 CS-7 P-53 SKR 3000 CS-7 SKR 3000 P-95 P-82 P-85 AeroDR Stitching system AeroDR SYSTEM 2 AeroDR P-51 CS-7 Bone Suppression Software CS-7 AeroDR P-21 AeroDR SYSTEM Linear Probe L18-4 Ultrasound System SONIMAGE HS1 Convex Probe C5-2 SKR 3000 CS-7 P-75 P-65 Linear Probe L14-4 Convex Probe MC10-3 Linear Probe L18-4 Linear Probe HL18-4 Sector Probe S4-2 Ultrasound System SONIMAGE MX1 Linear Probe L11-3 Convex Probe C5-2 Convex Probe C5-2 Ultrasound System SONIMAGE HS1 Sector Probe S4-2 Linear Probe L18-4 Linear Probe L14-4 Xpress Digital Mammography workstation ACIES

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2007-10-31
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2020-06-26
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2015-01-16
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2015-01-16
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2015-01-16
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2015-01-16
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2018-12-26
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2015-07-21
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2015-07-21
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2018-06-07
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2018-06-07
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2018-06-07
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2016-12-20
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2016-12-20
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2018-01-18
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2018-01-18
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2022-02-17
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2024-06-21
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2018-11-21
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2018-11-21
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2018-11-21
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2013-09-10
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2013-09-10
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2021-05-27
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2023-04-27
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2018-12-19
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2018-12-19
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2022-11-20
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2022-11-20
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2015-06-26
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2015-06-26
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2023-11-01
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2012-11-27
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2015-01-16
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2018-02-08
MUE Full Field Digital, System, X-Ray, Mammographic Radiology Class 2 892.1715 2012-01-05
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2008-06-27
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2015-01-16
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2015-01-16
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2016-11-06
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2016-11-06
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2016-11-06
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2015-01-16
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2024-12-01
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2024-12-01
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2022-02-17
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2022-02-17
KPR System, X-Ray, Stationary Radiology Class 2 892.1680 2012-07-05
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2014-10-06
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2014-10-06
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2024-06-21
KPR System, X-Ray, Stationary Radiology Class 2 892.1680 2012-04-16
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2012-04-16
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2014-11-24
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2014-11-24
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2014-11-24
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2021-08-26
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2021-08-26
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2022-08-05
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2022-08-05
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2022-08-05
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2016-02-04
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2016-02-04
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2016-02-04
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2024-12-12
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2015-01-16
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2015-01-16
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2015-01-16
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2019-09-20
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2011-11-21

Official Correspondent

Taketoh Muraoka

US Agent Details

Jan Maniscalco Business: Konica Minolta Healthcare Americas, Inc. Email: jan.maniscalco@konicaminolta.com Phone: (800) 9341034

Related Public Records

Same Entity

KONICA MINOLTA, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3003769120 KONICA MINOLTA, INC. HACHIOJI-SHI Tokyo, JP
3004485675 KONICA MINOLTA, INC. HINO-SHI Tokyo, JP

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K070563 Vidar Systems Corp. VIDAR VISION 2000 2007-03-16
K190691 Pixxgen Corporation Pixx2430 Digital Diagnostic X-Ray Receptor Panel 2019-04-04
K150150 Rayence Co., Ltd. 1717SGN / 1717SCN Digital Flat Panel X-ray Detector 2015-03-27
K140771 Philips Medical Systems Dmc GmbH PHILIPS ELEVA WORKSPOT 2014-04-25
K951723 GE Medical Systems GE B510 TRANSDUCER 1995-11-14

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0005-2009 Toshiba American Medical Systems Inc 2
Toshiba Infinix fluoroscopy DFP-8000D Digital Radiography System with version 3.40 or higher software. Controller for Infinix interventional angiography systems.
Z-0031-2007 AGFA Corp. 2
CR DX-S, Image Intensified Fluoroscopic X-ray system.
Z-0009-2022 DJO, LLC 2
GEL CONDUCTOR, Description/REF: 5 LITER W/DISP/4238, 24-8.5OZ BOTTLES/4248, 5 LITER/4266, distributed by DJO, LLC / DJO FRANCE in the following kits, Part/Description: 2073/ INTELECT RPW 120V, 2073-BR/ INTELECT RPW 120V BRAZIL, 2074/ INTELECT RPW 230 V, 2082/ INTELECT RPW 100 V, 2760/ INTELECT LEGEND XT COMBOUS STD, 2791/ INTELECT LEGEND XT COMBO US STD W/CART, 2782-10/ INTELECT TRANSPORT US STD, 2782-2/ INTELECT TRANSPORT US STD, 2843/ INTELECT VET 4CH COMBO PKG, 2845K/ KIT INTELECT VET 4CH COMBO PKG, 2863/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 5CM, 2863-10/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 10CM APPL, 2863-2/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 2CM APPL, 2864/ SENIOR SOLUTIONS 4CH COMBO PKG US STD, 2761/ VECTRA GENISYS 2CH COMBO PKG US STD 5CM APPL, 2792/ VECTRA GENISYS 2CH COMBO US STD W/CART, 2761-10/ VECTRA GENISYS 2CH COMBO PKG US STD 10CM APPL, 2761-2/ VECTRA GENISYS 2CH COMBO PKG US STD 2CM APPL, 2762CC/ INT ADV 2CH COLOR COMBO INT'L 5CM APPL, 2762CC-10/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD 10CM APPL, 2762CC-2/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD 2CM APPL, 2788/ LEGEND XT 4CH COMBO PKG US STD 5CM APPL, 2795/ INTELECT XT 4CH COMBO US STD 5CM APPL W/CART, 2788-10/ LEGEND XT 4CH COMBO PKG US STD 10CM APPL, 2795-10/ INTELECT XT4CH COMBO US STD 10CM APPL, 2788-2/ LEGEND XT 4CH COMBO PKG US STD 2CM APPL, 2795-2/ INTELECT XT 4CH COMBO US STD 2CM APPL, 2789/ VECTRA GENISYS 4CH COMBO PKG US 5CM APPL, 2796/ VECTRA GENISYS 4CH COMBO US STD W/CART, 2796K/ KIT VECTRA GENISYS 4CH COMBO P, 2789-10/ VECTRA GENISYS 4CH COMBO PKG US STD 10CM APPL, 2796-10/ VECTRA GENISYS 4CH COMBO US US STD 10CM APPL, 2789-2/ VECTRA GENISYS 4CH COMBO PKG US STD 2CM APPL, 2796-2/ VECTRA GENISYS 4CH COMBO US STD 2CM APPL, 2738/ INTELECT TRANSPORT COMBO PKG US STD, 8250KP/ KIT TRITON DTS PROMO, 6001/ INTELECT NEO, 2738-10/ INTELECT TRANSPORT COMBO PKG US STD, 2738-2/ INTELECT TRANSPORT COMBO PKG US STD, 2772MC/ INT ADVANCED COMBO MONOCHROMEINT'L STD, 2776/ INTELECT MOBILE INT'L STD 5CM APPL, 27800/ ULTRASOUND ON CART, 2776-BR/ INTELECT MOBILE INTL STD 5CM APPL BRAZIL, 2776-10/ INT MOBIL INT'L STD 10CM APPL, 2776-2/ INT MOBILE INT'L STD 2CM APPL, 2778/ INTELECT MOBILE COMBO INT'L STD 5CM APPL, 2778-10/ INTELECT MOBILE COMBO INT'L STD 10CM APPL, 2778-2/ INTELECT MOBILE COMBO INT'L STD 2CM APPL, 2752CC/ INT ADV 2CH COLOR COMBO INT'L STD, 2756/ INTELECT VET 2CH COMBO PKG INT'L STD, 2844K/ KIT INTELECT VET 2CH COMBO PKG, 2782/ INTELECT TRANSPORT US STD, 2895K/ KIT CART ADAPT BL W/CT/SPEC US, 2872/ VECTRA GEN 2C COMBO W/O EMG PK US STD, 2876/ VECTR GEN 2C COMBO W/O EMG US STD W/CART, 2874/ VECTRA GEN 4C COMBO W/O EMG PK US STD, 2878/ VECTR GEN 4C COMBO W/O EM US STD W/CART, 7550/ INT LEGEND COMBO 4C US STD, INT001/ INTELECT LEGEND ULTRASOUND US STD, INTC B/ INT CB PKGD US STD, 39-0701/ DIRECT SUPPLY PANACEA VECTRA 2-CHNL ULTRASOUND/ESTIM COMBO, 39-0702/ DIRECT SUPPLY PANACEA VECTRA 4-CHNL ULTRASOUND/ESTIM COMBO, 13-4248/ GEL CONDUCTOR 24-8.5OZ BOTTLES, 15-1200/ INTELECT MOBILE 2 ULTRASOUND INTL SET EU PLUG, 15-1201/ INTELECT MOBILE 2 ULTRASOUND INTL SET ALL PLUGS, 15-1204/ INTELECT MOBILE 2 COMBO INTL SET EU PLUG, 15-1205/ INTELECT MOBILE 2 COMBO INTL SET ALL PLUGS, 2173KIT/ INTELECT RPW 2 120V INTERNATIONAL KIT US PLUG, 2174KIT/ INTELECT RPW 2 230V KIT EU PLUG, 2175KIT/ INTELECT RPW 2 100V KIT JPN PLUG, 2176KIT/ INTELECT RPW 2 120V USA KIT, 12-2756-1/ INTELECT VET 2CH COMBO PKG INTL STD, 2756K/ KIT INTELECT VET 2CH COMBO PKGUS STD, 70002/ NEO MODULE ULTRASOUND
Z-0010-2022 DJO, LLC 2
Ultra-Myossage Lotion 1-gallon bottle, REF: 4262; Myossage Lotion 1-gallon bottle, REF: 4210, located in the following DJO, LLC / DJO FRANCE kits:
Z-0029-2022 Aesthetics Systems Usa Inc 2
Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005406110. Last updated year: 2026. Please use registration number 3005406110 when referencing this establishment in official correspondence.
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