Konica Medical Corp.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Konica Medical Corp.” (first 1990, latest 1999), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 176 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 | 0 | — |
| 2013 | 0 | — |
| 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 |
|---|---|---|---|
| IXW | Processor, Radiographic-Film, Automatic | 7 | 7 |
| LMA | Digitizer, Image, Radiological | 2 | 2 |
| EAM | Screen, Intensifying, Radiographic | 1 | 1 |
| IXA | Cassette, Radiographic Film | 1 | 1 |
| JAK | System, X-Ray, Tomography, Computed | 1 | 1 |
Review panels
- Radiology (12)
Most recent Konica Medical Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K990969 | KONICA SRX- 701 AUTOMATIC X-RAY FILM PROCESSOR | IXW | 1999-06-18 | 87 |
| K963914 | CM & CM DS-7 | IXA | 1997-10-08 | 373 |
| K963913 | MD100 & MM150 | EAM | 1997-10-08 | 373 |
| K955583 | VIFS | JAK | 1996-05-14 | 161 |
| K933830 | KONICA LD-4500 LASER DIGITIZER | LMA | 1993-12-14 | 131 |
| K931317 | KONICA SRX-301 AUTOMATIC X-RAY FILM PROCESSOR | IXW | 1993-12-14 | 274 |
| K931316 | KONICA DS-7 AUTOMATIC X-RAY FILM PROCESSOR | IXW | 1993-12-14 | 274 |
| K931315 | KONICA SRX-501A AUTOMATIC X-RAY FILM PROCESSOR | IXW | 1993-12-14 | 274 |
| K931314 | KONICA QX-70 AUTOMATIC X-RAY FILM PROCESSOR | IXW | 1993-09-07 | 176 |
| K931313 | KONICA QX-130APLUS AUTOMATIC X-RAY FILM PROCESSOR | IXW | 1993-09-07 | 176 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Konica Medical Corp..
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 Medical & Graphic, Inc. (27 510(k)s)
- Konica Minolta, Inc. (25 510(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 Medical Corp.?
FDA lists 12 510(k) clearances under the applicant name “Konica Medical Corp.” (first 1990, latest 1999), across 5 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 Medical Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Konica Medical Corp. is 176 days.
Which FDA product codes appear under Konica Medical Corp.?
The most frequent FDA product codes under this applicant name are IXW (Processor, Radiographic-Film, Automatic, 7); LMA (Digitizer, Image, Radiological, 2); EAM (Screen, Intensifying, Radiographic, 1).
Next steps
- See all 12 Konica Medical Corp. clearances with predicates and recalls
- Run predicate analysis for product code IXW, Konica Medical Corp.'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.