Data / Medical devices / Japan / Konica Minolta, Inc.
Konica Minolta, Inc.: FDA-registered device maker in HINO-SHI Tokyo, Japan, 44 510(k) clearances
Konica Minolta, Inc. is registered with the FDA (registration 3004485675) in HINO-SHI Tokyo, Japan. It lists 10 device types. The FDA files 44 510(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
- 3004485675
- Address
- 1 Sakura-Machi, HINO-SHI Tokyo, Japan, 191-8511
- Owner or operator
- KONICA MINOLTA, INC. (9009884)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- October 13, 2005
- Registered through
- 2026
- Brand names listed
- ACIES, AeroDR P-11, AeroDR P-12, AeroDR P-21, AeroDR P-31, AeroDR P-51, AeroDR P-52, AeroDR S30 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Camera, Multi Format, Radiological | LMC | 2 | Complaint file establishment | accessdata.fda.gov |
| Film, Radiographic | IWZ | 1 | 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 | Complaint file establishment | accessdata.fda.gov |
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | 2 | Specification developer | accessdata.fda.gov |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Specification developer | accessdata.fda.gov |
| System, X-Ray, Stationary | KPR | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 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 |
| June 23, 2022 | K220993 | Ultrasound System SONIMAGE MX1 | IYN | 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 |
| May 6, 2021 | K210066 | ImagePilot | LLZ | 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 |
| September 6, 2018 | K182153 | Ultrasound System SONIMAGE HS1 | IYO | Substantially Equivalent | Konica Minolta, Inc. | accessdata.fda.gov |
| February 8, 2018 | K180084 | Ultrasound System SONIMAGE MX1 | IYO | 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 19, 2016 | K162065 | Ultrasound System SONIMAGE HS1 | IYN | Substantially Equivalent | Konica Minolta, Inc. | accessdata.fda.gov |
| October 3, 2016 | K162504 | SKR 3000 | MQB | Substantially Equivalent | Konica Minolta, Inc. | accessdata.fda.gov |
| October 8, 2015 | K152577 | ULTRASOUND SYSTEM SONIMAGE HS 1 | IYN | Substantially Equivalent | Konica Minolta, Inc. | accessdata.fda.gov |
| June 29, 2015 | K151465 | AeroDR SYSTEM 2 | MQB | Substantially Equivalent | Konica Minolta, Inc. | accessdata.fda.gov |
| June 5, 2015 | K151060 | Ultrasound System SONIMAGE HS1 | IYO | Substantially Equivalent | Konica Minolta, Inc. | accessdata.fda.gov |
| November 21, 2014 | K142197 | ULTRASOUND SYSTEM SONIMAGE HS1, LINEAR PROBE L18-4, CONVEX PROBE C5-2 | IYN | Substantially Equivalent | Konica Minolta, Inc. | accessdata.fda.gov |
| October 28, 2014 | K141459 | APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM, V5.0 | IYN | Substantially Equivalent | Toshibamedical Systems Corporation | accessdata.fda.gov |
| September 26, 2014 | K141271 | AERODR SYSTEM 2 | MQB | Substantially Equivalent | Konica Minolta, Inc. | accessdata.fda.gov |
| January 31, 2014 | K133730 | CO PILOT/REGIUS UNITEA | LLZ | Substantially Equivalent | Konica Minolta, Inc. | accessdata.fda.gov |
| August 26, 2013 | K131527 | LOGIQ S8 | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| August 22, 2013 | K130936 | AERODR SYSTEM WITH P-31 | MQB | Substantially Equivalent | Konica Minolta Medical & Graphic, Inc. | accessdata.fda.gov |
| December 20, 2012 | K123499 | AEROPILOT | MQB | Substantially Equivalent | Konica Minolta Medical & Graphic, Inc. | accessdata.fda.gov |
| September 13, 2012 | K122491 | VIAMO SSA-640A V4.0 | IYN | Substantially Equivalent | Toshibamedical Systems Corporation | accessdata.fda.gov |
| June 8, 2012 | K120752 | AERODR STITCHING SYSTEM | KPR | Substantially Equivalent | Konica Minolta Medical & Graphic, Inc. | accessdata.fda.gov |
| May 23, 2012 | K121109 | AERODR X70 | 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 |
| February 4, 2011 | K101842 | ACIES | LLZ | 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 |
| August 15, 2006 | K061999 | DRY LASER IMAGER, DRYPRO MODEL 832 | LMC | 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 Instrument, Quality-Assurance, Radiologic
- All makers of Camera, Multi Format, Radiological
- All makers of Transducer, Ultrasonic, Diagnostic
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
- All makers of System, Imaging, Pulsed Doppler, Ultrasonic
- All makers of System, Image Processing, Radiological
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.