Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003769120

FEI Number

3003769120

Entity Name

KONICA MINOLTA, INC.

City/State/Country

HACHIOJI-SHI Tokyo, JP

Establishment Address

2970 ISHIKAWA-MACHI, HACHIOJI-SHI Tokyo 192-8505, JP

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

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

K241319

PMA Number

N/A

All Registered Proprietary Names

KONICAMINOLTA DI-X1 CS-7 SKR 3000 REGIUS Plate FP-1S REGIUS Cassette RC-300 REGIUS SIGMA2 REGIUS Cassette/Plate REGIUS Cassette REGIUS Plate REGIUS MODEL 110HQ REGIUS MODEL 110 KONICAMINOLTA DI-X1 KONICAMINOLTA DI-X1 REGIUS Cassette RC-300 REGIUS Plate FP-1S REGIUS SIGMA CS-7 AeroDR P-21 AeroDR SYSTEM P-53 CS-7 SKR 3000 AeroSync REGIUS Plate REGIUS Cassette REGIUS Cassette/Plate REGIUS MODEL 210 CS-7 P-61 SKR 3000 Xpress Digital Mammography System AeroDR SYSTEM 2 AeroDR P-51 CS-7 AeroDR SYSTEM CS-7 AeroDR P-31 SKR 3000 P-61 CS-7 AeroDR P-12 AeroDR P-11 CS-7 AeroDR SYSTEM DRYPRO MODEL 873 CS-7 SKR 3000 P-95 P-82 P-85 P-65 P-75 CS-7 G-59 SKR 3000 G-60 G-22 SKR 3000 CS-7 P-75 P-65 CS-7 P-53 SKR 3000

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	2021-09-22
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	2012-11-27
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2007-10-31
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2018-12-26
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	2011-06-06
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
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
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2012-04-12
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2009-12-15
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
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	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	2013-09-10
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2013-09-10
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
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2010-11-29
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	2022-02-17
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2022-02-17
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
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
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

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
3005406110	KONICA MINOLTA TECHNOPRODUCTS CO., LTD.	SAYAMA-SHI Saitama, JP
3004485675	KONICA MINOLTA, INC.	HINO-SHI Tokyo, 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)

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3030088963	REBRAIN	PESSAC Gironde, FR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003769120. Last updated year: 2026. Please use registration number 3003769120 when referencing this establishment in official correspondence.