Agfa Healthcare Corporation: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Agfa Healthcare Corporation” (first 2007, latest 2008), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 14 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 |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | 5 | 5 |
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 2 | 2 |
| LMC | Camera, Multi Format, Radiological | 1 | 1 |
Review panels
- Radiology (8)
Most recent Agfa Healthcare Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K081976 | IMPAX MA3000 DIAGNOSTIC PACS WORKSTATION | LLZ | 2008-07-28 | 17 |
| K081963 | AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX2008 WORKSTATIONS | MQB | 2008-07-25 | 15 |
| K080013 | REGISTRATION AND FUSION | LLZ | 2008-01-17 | 14 |
| K073271 | ORTHOGON | LLZ | 2007-12-05 | 14 |
| K072680 | DRYSTAR AXYS, MODEL EYZ4E | LMC | 2007-10-25 | 31 |
| K071972 | ORTHOPEDIC SOFTWARE FOR IMPAX WORKSTATIONS | LLZ | 2007-07-30 | 13 |
| K071297 | IMPAX SE SIGMACOM CLIENT (PACS WORKSTATION) | LLZ | 2007-06-22 | 44 |
| K071162 | AGFA COMPUTED RADIOGRAPHY SYSTEM WITH NX2.X WORKSTATIONS | MQB | 2007-05-08 | 12 |
Recalls
12 product recalls in 12 recall events; 1 initiated in the last five years. Most recent: 2025-11-18.
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 Corp. (23 510(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 Healthcare Corporation?
FDA lists 8 510(k) clearances under the applicant name “Agfa Healthcare Corporation” (first 2007, latest 2008), across 3 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 Healthcare Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name Agfa Healthcare Corporation is 14 days.
Which FDA product codes appear under Agfa Healthcare Corporation?
The most frequent FDA product codes under this applicant name are LLZ (System, Image Processing, Radiological, 5); MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager), 2); LMC (Camera, Multi Format, Radiological, 1).
Next steps
- See all 8 Agfa Healthcare Corporation clearances with predicates and recalls
- Run predicate analysis for product code LLZ, Agfa Healthcare Corporation'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.