Agfa N.V.: FDA clearances and approvals
Agfa N.V. has 6 FDA 510(k) clearances (first 2019, latest 2021), across 4 product codes in 1 review panel. Median 510(k) review time: 52 days. Since 2017 its median was 52 days, against 50 days for all cleared 510(k)s in the same product codes. openFDA lists 7 product recalls by a recalling firm named Agfa N.V.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2019 | 2 | 48 |
| 2020 | 1 | 104 |
| 2021 | 3 | 50 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Agfa N.V.'s cleared 510(k)s took a median 52 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 50 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IZF | System, X-Ray, Tomographic | 2 | 2 |
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 2 | 2 |
| IZL | System, X-Ray, Mobile | 1 | 1 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 1 | 1 |
Review panels
- Radiology (6)
Most recent Agfa N.V. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K213469 | VALORY | MQB | 2021-11-18 | 21 |
| K212145 | DR 800 with DSA, DR 800 | JAA | 2021-08-31 | 53 |
| K211790 | DX-D Imaging Package with XD Detectors | MQB | 2021-07-30 | 50 |
| K193262 | DR 600 with Tomosynthesis | IZF | 2020-03-09 | 104 |
| K191884 | DR 100s | IZL | 2019-08-09 | 25 |
| K183275 | DR 800 with Tomosynthesis | IZF | 2019-02-01 | 70 |
Recalls
7 product recalls in 7 recall events; 2 initiated in the last five years. Most recent: 2024-07-29.
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 Agfa N.V. have?
Agfa N.V. has 6 FDA 510(k) clearances (first 2019, latest 2021), across 4 product codes in 1 review panel.
How long does FDA take to clear Agfa N.V.'s 510(k)s?
The median time from FDA receipt to decision across Agfa N.V.'s cleared 510(k)s is 52 days. Since 2017: 52 days, versus 50 days for all cleared 510(k)s in the same product codes.
What devices does Agfa N.V. make?
Its most frequent FDA product codes are IZF (System, X-Ray, Tomographic, 2); MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager), 2); IZL (System, X-Ray, Mobile, 1).
Has Agfa N.V. had device recalls?
openFDA lists 7 product recalls in 7 recall events by a recalling firm whose name matches Agfa N.V; the most recent began 2024-07-29. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 6 Agfa N.V. clearances with predicates and recalls
- Run predicate analysis for product code IZF, Agfa N.V.'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.