Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004485675

FEI Number

3004485675

Entity Name

KONICA MINOLTA, INC.

City/State/Country

HINO-SHI Tokyo, JP

Establishment Address

1 SAKURA-MACHI, HINO-SHI Tokyo 191-8511, JP

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

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

Expiration Date (Year)

2026

510(k) Number

K051523

PMA Number

N/A

All Registered Proprietary Names

AeroDR SYSTEM 2 AeroDR P-51 CS-7 SKR 3000 CS-7 P-81 P-71 Ultrasound System SONIMAGE HS1 Sector Probe S4-2 Convex Probe C5-2 Linear Probe L18-4 CS-7 AeroDR P-21 AeroDR SYSTEM REGIUS Plate REGIUS Cassette REGIUS Cassette/Plate REGIUS MODEL 210 AeroDR S30 AeroDR S33 AeroDR T50 AeroDR X70 Ceiling Suspension (0170CS) AeroDR X70 KONICAMINOLTA DI-X1 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 Bone Suppression Software Xpress Digital Mammography System CS-7 P-61 SKR 3000 DRYPRO TH CS-7 SKR 3000 AeroDR P-12 AeroDR P-11 CS-7 AeroDR SYSTEM Simple Check QC Phantom-2 DRYPRO MODEL 873 AeroSync DRYPRO MODEL 832 P-65 P-75 CS-7 G-59 SKR 3000 G-60 G-22 REGIUS Plate FP-1S REGIUS Cassette RC-300 REGIUS SIGMA2 AeroDR Stitching system AeroDR SYSTEM CS-7 AeroDR P-31 ImagePilot CS-7 P-53 SKR 3000 P-41 SKR 4000 SKR 3000 P-61 CS-7 Linear Probe L18-4 Ultrasound System SONIMAGE HS1 Convex Probe C5-2 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 P-53 CS-7 SKR 3000 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 REGIUS Cassette RC-300 REGIUS Plate FP-1S REGIUS SIGMA Convex Probe C5-2 Linear Probe L11-3 Convex Probe MC10-3 Linear Probe L14-4 Ultrasound System SONIMAGE MX1 CS-7 SKR 3000 P-95 P-82 P-85 KONICAMINOLTA DI-X1 MEDICAL IMAGING FILM SD-QM2 MEDICAL IMAGING FILM SD-PC X-RAY FILM MG-SR PLUS MEDICAL IMAGING FILM SR-IC PLUS MEDICAL IMAGING FILM SD-P MEDICAL IMAGING FILM SD-QM MEDICAL IMAGING FILM SD-Q X-RAY FILM CM-H2 for MAMMOGRAPHY MEDICAL IMAGING FILM SD-S MEDICAL IMAGING FILM SD-PM MEDICAL DUPLICATING FILM SR-DUP PLUS MEDICAL IMAGING FILM SD-E MEDICAL IMAGING FILM SD-Q2 MEDICAL IMAGING FILM TR-S

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
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
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
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
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2015-08-04
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2015-08-04
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2015-08-04
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
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2009-12-15
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2012-06-05
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2021-09-22
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
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2013-03-19
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2024-06-21
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	2020-05-11
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2020-05-11
LMC	Camera, Multi Format, Radiological	Radiology	Class 2	892.2040	2025-07-18
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
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2016-03-25
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2016-03-25
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2016-03-25
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2010-11-29
LHO	Instrument, Quality-Assurance, Radiologic	Radiology	Class 1	892.1940	2007-08-17
LMC	Camera, Multi Format, Radiological	Radiology	Class 2	892.2040	2008-12-08
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2012-04-12
LMC	Camera, Multi Format, Radiological	Radiology	Class 2	892.2040	2008-06-25
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
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2012-11-27
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2012-07-05
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
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
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2014-02-11
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2020-04-13
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
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
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
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2026-03-11
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2026-03-11
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	2011-06-06
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
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	2022-02-17
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2022-02-17
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2018-12-26
IWZ	Film, Radiographic	Radiology	Class 1	892.1840	2005-10-13
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2008-06-27

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
3005406110	KONICA MINOLTA TECHNOPRODUCTS CO., LTD.	SAYAMA-SHI Saitama, JP

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K080013	Agfa Healthcare Corporation	REGISTRATION AND FUSION	2008-01-17
K042221	Barco NV Barcoview	CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM	2004-12-30
K092915	Cedara Software Corp.	CEDARA WEBACCESS, MODEL: 2.4	2010-06-23
K961871	Siemens Medical Solutions USA, Inc.	FLOUROSPOT T.O.P.	1996-07-31
K122260	Aycan Digitalsysteme GmbH	AYCAN MOBILE	2012-09-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2022	GE Healthcare, LLC	2	Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0023-2016	GE Healthcare	2	Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Z-0030-2026	CHANGE HEALTHCARE CANADA COMPANY	2	Change Healthcare Radiology Solutions software version 14.2.2
Z-0032-2012	Philips Healthcare Inc.	2	MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).
Z-0033-2007	AGFA Corp.	2	IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)

Similar Registrations

Registration Number	Establishment Name	Location
3017991646	CARDIOWISE, INC.	Fayetteville, AR, US
3007120336	GE Healthcare Magyarorszag Kft.	Budapest, HU
3036758981	TAEYOUNG SOFT	Gwacheon-si Gyeonggi, KR
3010956703	Visual Medica	Ciudad Autonoma Buenos Aires Buenos Aires, Ciudad Autonoma de, AR
3030088963	REBRAIN	PESSAC Gironde, FR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004485675. Last updated year: 2026. Please use registration number 3004485675 when referencing this establishment in official correspondence.