Data / Medical devices / Japan / Konica Minolta, Inc.
Konica Minolta, Inc.: FDA-registered device maker in HACHIOJI-SHI Tokyo, Japan, 28 510(k) clearances
Konica Minolta, Inc. is registered with the FDA (registration 3003769120) in HACHIOJI-SHI Tokyo, Japan. It lists 6 device types. The FDA files 28 510(k) clearances under its listings, the newest dated June 17, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003769120
- Address
- 2970 Ishikawa-Machi, HACHIOJI-SHI Tokyo, Japan, 192-8505
- Owner or operator
- KONICA MINOLTA, INC. (9009884)
- Roles
- Specification developer
- First device listed
- August 17, 2007
- Registered through
- 2026
- Brand names listed
- AeroDR P-11, AeroDR P-12, AeroDR P-21, AeroDR P-31, AeroDR P-51, AeroDR P-52, AeroDR SYSTEM, AeroDR SYSTEM 2 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Camera, Multi Format, Radiological | LMC | 2 | Specification developer | accessdata.fda.gov |
| Full Field Digital, System, X-Ray, Mammographic | MUE | 2 | Specification developer | accessdata.fda.gov |
| Instrument, Quality-Assurance, Radiologic | LHO | 1 | Specification developer | accessdata.fda.gov |
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | 2 | Specification developer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Specification developer | accessdata.fda.gov |
| System, X-Ray, Stationary | KPR | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 17, 2025 | K250665 | SKR 3000 | MQB | Substantially Equivalent | Konica Minolta, Inc. | accessdata.fda.gov |
| November 21, 2024 | K241319 | SKR 3000 | MQB | Substantially Equivalent | Konica Minolta, Inc. | accessdata.fda.gov |
| May 31, 2024 | K240281 | Bone Suppression Software | LLZ | Substantially Equivalent | Konica Minolta, Inc. | accessdata.fda.gov |
| April 25, 2023 | K230906 | Konicaminolta DI-X1 | LLZ | Substantially Equivalent | Konica Minolta, Inc. | accessdata.fda.gov |
| November 17, 2022 | K223267 | SKR 3000 | MQB | Substantially Equivalent | Konica Minolta, Inc. | accessdata.fda.gov |
| January 31, 2022 | K213908 | SKR 3000 | MQB | Substantially Equivalent | Konica Minolta, Inc. | accessdata.fda.gov |
| September 13, 2021 | K212685 | KONICAMINOLTA DI-X1 | LLZ | Substantially Equivalent | Konica Minolta, Inc. | accessdata.fda.gov |
| August 24, 2021 | K210619 | SKR 3000 | MQB | Substantially Equivalent | Konica Minolta, Inc. | accessdata.fda.gov |
| August 16, 2019 | K191645 | SKR 4000 | MQB | Substantially Equivalent | Konica Minolta, Inc. | accessdata.fda.gov |
| December 18, 2018 | K182688 | SKR 3000 | MQB | Substantially Equivalent | Konica Minolta, Inc. | accessdata.fda.gov |
| November 26, 2018 | K182431 | Konicaminolta DI-X1 | LLZ | Substantially Equivalent | Konica Minolta, Inc. | accessdata.fda.gov |
| October 12, 2017 | K172793 | SKR 3000 | MQB | Substantially Equivalent | Konica Minolta, Inc. | accessdata.fda.gov |
| August 25, 2017 | K171716 | SKR 3000 | MQB | Substantially Equivalent | Konica Minolta, Inc. | accessdata.fda.gov |
| October 3, 2016 | K162504 | SKR 3000 | MQB | Substantially Equivalent | Konica Minolta, Inc. | accessdata.fda.gov |
| June 29, 2015 | K151465 | AeroDR SYSTEM 2 | MQB | Substantially Equivalent | Konica Minolta, Inc. | accessdata.fda.gov |
| September 26, 2014 | K141271 | AERODR SYSTEM 2 | MQB | Substantially Equivalent | Konica Minolta, Inc. | accessdata.fda.gov |
| August 22, 2013 | K130936 | AERODR SYSTEM WITH P-31 | MQB | Substantially Equivalent | Konica Minolta Medical & Graphic, Inc. | accessdata.fda.gov |
| June 8, 2012 | K120752 | AERODR STITCHING SYSTEM | KPR | Substantially Equivalent | Konica Minolta Medical & Graphic, Inc. | accessdata.fda.gov |
| April 9, 2012 | K120477 | AEROSYNC FOR AERODR SYSTEM | MQB | Substantially Equivalent | Konica Minolta Medical & Graphic, Inc. | accessdata.fda.gov |
| February 10, 2012 | K120131 | REGIUS SIGMA2 | MQB | Substantially Equivalent | Konica Minolta Medical & Graphic, Inc. | accessdata.fda.gov |
| January 17, 2012 | K113248 | AERODR SYSTEM WITH P-21 | KPR | Substantially Equivalent | Konica Minolta Medical & Graphic, Inc. | accessdata.fda.gov |
| December 23, 2011 | K110717 | KONICA MINOLTA XPRESS DIGITAL MAMMOGRAPHY SYSTEM | MUE | Substantially Equivalent | Konica Minolta Medical & Graphic, Inc. | accessdata.fda.gov |
| June 2, 2011 | K103703 | REGUIS SIGMA | MQB | Substantially Equivalent | Konica Minolta Medical & Graphic, Inc. | accessdata.fda.gov |
| November 24, 2010 | K102349 | AERODR SYSTEM | KPR | Substantially Equivalent | Konica Minolta Medical & Graphic, Inc. | accessdata.fda.gov |
| October 30, 2009 | K092717 | DIRECT DIGITIZER, REGIUS MODEL 210 | MQB | Substantially Equivalent | Konica Minolta Medical & Graphic, Inc. | accessdata.fda.gov |
| July 1, 2008 | K081637 | LASER IMAGER DRYPRO MODEL 873 | LMC | Substantially Equivalent | Konica Minolta Medical & Graphic, Inc. | accessdata.fda.gov |
| May 30, 2007 | K071181 | DIRECT DIGITIZER, REGIUS MODEL 110 | MQB | Substantially Equivalent | Konica Minolta Medical & Graphic, Inc. | accessdata.fda.gov |
| July 20, 2005 | K051523 | REGIUS CONSOLE CS-2000 AND REGIUS CONSOLE CS-3000, MEDICAL IMAGE PROCESSING WORKSTATION | LLZ | Substantially Equivalent | Konica Minolta Medical & Graphic, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Full Field Digital, System, X-Ray, Mammographic
- All makers of System, Image Processing, Radiological
- All makers of Camera, Multi Format, Radiological
- All makers of Solid State X-Ray Imager (Flat Panel/Digital Imager)
- All makers of Instrument, Quality-Assurance, Radiologic
- All makers of System, X-Ray, Stationary
Updated June 17, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.