Agfa Corp.: FDA filings under this applicant name
FDA lists 23 510(k) clearances under the applicant name “Agfa Corp.” (first 2000, latest 2006), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 29 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 |
|---|---|---|---|
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 7 | 7 |
| LLZ | System, Image Processing, Radiological | 6 | 6 |
| LMC | Camera, Multi Format, Radiological | 6 | 6 |
| IXK | System, Imaging, X-Ray, Electrostatic | 2 | 2 |
| IXA | Cassette, Radiographic Film | 1 | 1 |
| MUH | System, X-Ray, Extraoral Source, Digital | 1 | 1 |
Review panels
- Radiology (23)
Most recent Agfa Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K063421 | DX-SI | MQB | 2006-11-22 | 9 |
| K062742 | CR 85-X | MQB | 2006-10-13 | 29 |
| K062223 | AGFA MODEL CR30-X | MQB | 2006-09-01 | 30 |
| K053634 | COMPUTED RADIOGRAPHY SYSTEM WITH NX 1.0 WORKSTATION | MQB | 2006-01-17 | 19 |
| K053458 | WEB1000 | LLZ | 2005-12-22 | 9 |
| K052251 | DRYSTAR MODEL 5500 | LMC | 2005-08-31 | 13 |
| K050810 | AGFA CR50.0 | MQB | 2005-04-21 | 21 |
| K050751 | IMPAX ORTHOPAEDIC WORKSTATION, MODEL IMPAX ES 5.X | LLZ | 2005-04-21 | 29 |
| K042779 | RADIOTHERAPY SOLUTION BASED ON CR | IXK | 2004-10-21 | 15 |
| K041701 | AFGA CR25.0 COMPUTED RADIOGRAPHY SYSTEM | MQB | 2004-07-22 | 30 |
13 earlier clearances. See the full list in Caduvo.
Recalls
57 product recalls in 54 recall events; 0 initiated in the last five years. Most recent: 2014-06-06.
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.
- Agfa Healthcare N.V. (27 510(k)s)
- Agfa Healthcare Corporation (8 510(k)s)
- Agfa N.V. (6 510(k)s)
- Agfa Medical Imaging (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Agfa Corp.?
FDA lists 23 510(k) clearances under the applicant name “Agfa Corp.” (first 2000, latest 2006), 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 Agfa Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Agfa Corp. is 29 days.
Which FDA product codes appear under Agfa Corp.?
The most frequent FDA product codes under this applicant name are MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager), 7); LLZ (System, Image Processing, Radiological, 6); LMC (Camera, Multi Format, Radiological, 6).
Next steps
- See all 23 Agfa Corp. clearances with predicates and recalls
- Run predicate analysis for product code MQB, Agfa 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.