Agfa Healthcare N.V.: FDA clearances and approvals
Agfa Healthcare N.V. has 27 FDA 510(k) clearances (first 2009, latest 2025), across 7 product codes in 2 review panels. Median 510(k) review time: 69 days. Since 2017 its median was 62 days, against 102 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 72 |
| 2013 | 2 | 140 |
| 2014 | 5 | 88 |
| 2015 | 3 | 140 |
| 2016 | 2 | 98 |
| 2017 | 2 | 84 |
| 2018 | 1 | 30 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 93 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Agfa Healthcare N.V.'s cleared 510(k)s took a median 62 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 102 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 13 | 13 |
| LLZ | System, Image Processing, Radiological | 8 | 8 |
| KPR | System, X-Ray, Stationary | 2 | 2 |
| IZL | System, X-Ray, Mobile | 1 | 1 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 1 | 1 |
| MUE | Full Field Digital, System, X-Ray, Mammographic | 1 | 1 |
| NQQ | System, Imaging, Optical Coherence Tomography (Oct) | 1 | 1 |
Review panels
- Radiology (26)
- General and Plastic Surgery (1)
Most recent Agfa Healthcare N.V. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252199 | AGFA HealthCare Enterprise Imaging | LLZ | 2025-10-15 | 93 |
| K180589 | DR 800 with MUSICA Dynamic | JAA | 2018-04-05 | 30 |
| K172784 | DX-D Imaging Package | MQB | 2017-10-13 | 28 |
| K170434 | Enterprise Imaging XERO Viewer 8.1 | LLZ | 2017-07-03 | 140 |
| K161368 | DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s) | MQB | 2016-09-22 | 128 |
| K161061 | IMPAX Volume Viewing 4.0 | LLZ | 2016-06-22 | 68 |
| K152639 | DR 600 | MQB | 2015-12-11 | 87 |
| K143397 | ICIS View | LLZ | 2015-06-01 | 187 |
| K142316 | IMPAX Agility | LLZ | 2015-01-06 | 140 |
| K142184 | DX-D IMAGING PACKAGE | MQB | 2014-10-16 | 69 |
17 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Agfa Healthcare N.V..
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 Healthcare N.V. have?
Agfa Healthcare N.V. has 27 FDA 510(k) clearances (first 2009, latest 2025), across 7 product codes in 2 review panels.
How long does FDA take to clear Agfa Healthcare N.V.'s 510(k)s?
The median time from FDA receipt to decision across Agfa Healthcare N.V.'s cleared 510(k)s is 69 days. Since 2017: 62 days, versus 102 days for all cleared 510(k)s in the same product codes.
What devices does Agfa Healthcare N.V. make?
Its most frequent FDA product codes are MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager), 13); LLZ (System, Image Processing, Radiological, 8); KPR (System, X-Ray, Stationary, 2).
Has Agfa Healthcare N.V. had device recalls?
openFDA lists no recalls under a recalling firm name matching Agfa Healthcare N.V. Related entities may recall under other names.
Next steps
- See all 27 Agfa Healthcare N.V. clearances with predicates and recalls
- Run predicate analysis for product code MQB, Agfa Healthcare 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.