Chrysalis Intelligence · Sponsors · Agfa N.V.

Agfa N.V.

Mortsel, BE · 4 510(k) clearances · 4 recalls

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Total clearances
4
2020-03-09 → 2021-11-18
Last 12 months
0
Product codes
3
Most recent
2021-11-18
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Class II Radiology 2 2021-11-18
JAA System, X-Ray, Fluoroscopic, Image-Intensified Class II Radiology 1 2021-08-31
IZF System, X-Ray, Tomographic Class II Radiology 1 2020-03-09
Safety

Recalls (4)

Class I (serious)
0
Risk of injury / death
Total recalls
4
Currently ongoing
2
Most recent
2024-07-29
DateSeverityStatusRecall # ProductCodeReason
2024-07-29 Class II Ongoing Z-2738-2024 DR 800. Digital Radiography X-ray System. — Potential for the front lever chain of the DR 800 table to fail.
2024-02-23 Class II Ongoing Z-1462-2024 Agfa DX-D 100 system-Digital Radiography mobile X-ray System. A mobile X-Ray modality, consisting of X-Ray console, gene… — Steel cable installed inside the mobile column which supports the weight of the telescopic arm with the tube head has potential risk -an interference could caus…
2020-04-06 Class II Terminated Z-2202-2020 AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic, Type number: 6010/200 - Product Usage: DR 800: Agfa s… — Under specific conditions (Fluoroscopic exam, ABS=OFF, manual change of parameters) wrong calculation of the dose/minute for fluoroscopy exams can be possible
2020-02-10 Class II Terminated Z-1502-2020 AGFA Digital Radiography X- Ray system DR 800 with TomoSynthesis- a Tomographic X-ray system - Product Usage: TomoSynthe… — Tomosynthesis image acquisition sequence did not stop automatically after expected number of exposures.
Filings

All 510(k) clearances (4)

Date K-number Device Code Class Specialty
2021-11-18 K213469 VALORY MQB Class II Radiology
2021-08-31 K212145 DR 800 with DSA, DR 800 JAA Class II Radiology
2021-07-30 K211790 DX-D Imaging Package with XD Detectors MQB Class II Radiology
2020-03-09 K193262 DR 600 with Tomosynthesis IZF Class II Radiology
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence