Konica Minolta Medical & Graphic, Inc.: FDA filings under this applicant name
FDA lists 27 510(k) clearances under the applicant name “Konica Minolta Medical & Graphic, Inc.” (first 2002, latest 2013), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 57 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 6 | 47 |
| 2013 | 1 | 140 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 13 | 13 |
| KPR | System, X-Ray, Stationary | 4 | 4 |
| LLZ | System, Image Processing, Radiological | 4 | 4 |
| LMC | Camera, Multi Format, Radiological | 4 | 4 |
| IXA | Cassette, Radiographic Film | 1 | 1 |
| MUE | Full Field Digital, System, X-Ray, Mammographic | 1 | 1 |
Review panels
- Radiology (27)
Most recent Konica Minolta Medical & Graphic, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K130936 | AERODR SYSTEM WITH P-31 | MQB | 2013-08-22 | 140 |
| K123499 | AEROPILOT | MQB | 2012-12-20 | 37 |
| K120752 | AERODR STITCHING SYSTEM | KPR | 2012-06-08 | 88 |
| K121109 | AERODR X70 | KPR | 2012-05-23 | 41 |
| K120477 | AEROSYNC FOR AERODR SYSTEM | MQB | 2012-04-09 | 53 |
| K120131 | REGIUS SIGMA2 | MQB | 2012-02-10 | 24 |
| K113248 | AERODR SYSTEM WITH P-21 | KPR | 2012-01-17 | 75 |
| K110717 | KONICA MINOLTA XPRESS DIGITAL MAMMOGRAPHY SYSTEM | MUE | 2011-12-23 | 283 |
| K103703 | REGUIS SIGMA | MQB | 2011-06-02 | 164 |
| K101842 | ACIES | LLZ | 2011-02-04 | 218 |
17 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Konica Minolta Medical & Graphic, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Konica Minolta, Inc. (25 510(k)s)
- Konica Medical Corp. (12 510(k)s)
- Konica Minolta Healthcare Americas, Inc. (6 510(k)s)
- Konica Corp. (5 510(k)s)
- Konica Minolta Sensing, Inc. (3 510(k)s)
- Konica Medical and Graphic Corporation (1 510(k)s)
- Konica Minolta Technoproduct Co., Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Konica Minolta Medical & Graphic, Inc.?
FDA lists 27 510(k) clearances under the applicant name “Konica Minolta Medical & Graphic, Inc.” (first 2002, latest 2013), across 6 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Konica Minolta Medical & Graphic, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Konica Minolta Medical & Graphic, Inc. is 57 days.
Which FDA product codes appear under Konica Minolta Medical & Graphic, Inc.?
The most frequent FDA product codes under this applicant name are MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager), 13); KPR (System, X-Ray, Stationary, 4); LLZ (System, Image Processing, Radiological, 4).
Next steps
- See all 27 Konica Minolta Medical & Graphic, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MQB, Konica Minolta Medical & Graphic, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.