Konica Minolta Medical & Graphic, Inc.: FDA clearances and approvals
Konica Minolta Medical & Graphic, Inc. has 27 FDA 510(k) clearances (first 2002, latest 2013), across 6 product codes in 1 review panel. Median 510(k) review time: 57 days.
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 company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Konica Minolta Medical & Graphic, Inc. have?
Konica Minolta Medical & Graphic, Inc. has 27 FDA 510(k) clearances (first 2002, latest 2013), across 6 product codes in 1 review panel.
How long does FDA take to clear Konica Minolta Medical & Graphic, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Konica Minolta Medical & Graphic, Inc.'s cleared 510(k)s is 57 days.
What devices does Konica Minolta Medical & Graphic, Inc. make?
Its most frequent FDA product codes are MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager), 13); KPR (System, X-Ray, Stationary, 4); LLZ (System, Image Processing, Radiological, 4).
Has Konica Minolta Medical & Graphic, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Konica Minolta Medical & Graphic, Inc. Related entities may recall under other names.
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. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.