Agfa N.V.
Mortsel Antwerpen, BE
AGFA N.V. appears in FDA device records in Mortsel Antwerpen, BE. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 7 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for Agfa N.V. between 2019 and 2021. The busiest year on record is 2021, with 3. The most recent is 2021, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2019 | 2 |
| 2020 | 1 |
| 2021 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K213469 | VALORY | MQB | Substantially Equivalent | |
| K212145 | DR 800 with DSA, DR 800 | JAA | Substantially Equivalent | |
| K211790 | DX-D Imaging Package with XD Detectors | MQB | Substantially Equivalent | |
| K193262 | DR 600 with Tomosynthesis | IZF | Substantially Equivalent | |
| K191884 | DR 100s | IZL | Substantially Equivalent | |
| K183275 | DR 800 with Tomosynthesis | IZF | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3001556265 | 3001556265 | AGFA N.V. | Septestraat 27, Mortsel Antwerpen B-2640 BE | 2026 | and 3 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- LMCCamera, Multi Format, Radiological
- IWZFilm, Radiographic
- MUEFull Field Digital, System, X-Ray, Mammographic
- IXJGrid, Radiographic
- IXYHolder, Radiographic Cassette, Wall-Mounted
- LHOInstrument, Quality-Assurance, Radiologic
- OIPRadiology-Diagnostic Kit
- MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)
- LLZSystem, Image Processing, Radiological
- JAASystem, X-Ray, Fluoroscopic, Image-Intensified
- IZLSystem, X-Ray, Mobile
- KPRSystem, X-Ray, Stationary
- IZFSystem, X-Ray, Tomographic
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2738-2024 | DR 800. Digital Radiography X-ray System. | Potential for the front lever chain of the DR 800 table to fail. | Class II | Open, Classified | |
| Z-1462-2024 | Agfa DX-D 100 system-Digital Radiography mobile X-ray System. A mobile X-Ray modality, consisting of X-Ray console, generator, tube, digital detector, and workstation. This modality is used to generate projection X-Ray images of human patients. Models: 5411/ 050, A5411/ 0300 and A5411/ 0400 | 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 cause the safety system which blocks the arm if the cable is cut off does not work properly, may result in patient injury | Class II | Open, Classified | |
| Z-2202-2020 | AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic, Type number: 6010/200 - Product Usage: DR 800: Agfa s DR 800 system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence) of the following anatomies/procedures: positioning fluoroscopy procedures, gastro-intestinal examinations, urogenital tract examinations, and angiography. It is intended to replace fluoroscopic images obtained through image intensifier technology. In addition, the system is intended for project radiography of all body parts. The DR 800 is not intended for mammography applications | Under specific conditions (Fluoroscopic exam, ABS=OFF, manual change of parameters) wrong calculation of the dose/minute for fluoroscopy exams can be possible | Class II | Terminated | |
| Z-1502-2020 | AGFA Digital Radiography X- Ray system DR 800 with TomoSynthesis- a Tomographic X-ray system - Product Usage: TomoSynthesis is used to synthesize tomographic slices from a single tomographic sweep. The DR 800 is not intended for mammography applications | Tomosynthesis image acquisition sequence did not stop automatically after expected number of exposures. | Class II | Terminated | |
| Z-2056-2019 | AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Product Usage: The Agfa s DR 800 system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence) of the following an anatomies/procedures: positioning fluoroscopy procedures, gastro-intestinal examinations, urogenital tract examinations, and angiography. It is intended to replace fluoroscopic images obtained through image intensifier technology. In addition, the system is intended for project radiography of all body parts. The DR 800 is not intended for mammography applications. | The exposed area of fluo exams possibly does not match the active area of the detector within specified limits. | Class II | Terminated | |
| Z-1034-2019 | PET Plates Coated Film-MONOMEDBV2S2- Radiographic Film REF: XJUB8, XJM73, XJUDD, XJM85, EKLYZ. Product Usage: Due to an inhomogeneous coating solution, pinholes can become visible in even dark images. Visibility of the pinholes varies as material from this coating run shows pinholes in different frequencies and intensities. | Due to an inhomogeneous coating solution, pinholes can become visible in even dark images. Visibility of the pinholes varies as material from this coating run shows pinholes in different frequencies and intensities | Class III | Terminated | |
| Z-3245-2018 | DX-D 600 Product Usage: The DX-D 600 system is a ceiling mounted General Radiography X-Ray imaging system used in hospitals, clinics and medical practices by physicists, radiographers and radiologists to make, process and view static X-Ray radiographic images of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts on adult, pediatric or neonatal patients. | A supplier for the Agfa system noted a potential for the steel support cables of a similar device to break. This led to a mandatory review of all systems, changing the pulley and cables if any deterioration in the cables or irregular or excessive pulley wear. If the two cables that support the equipment to its roof anchor break, the equipment might fall and cause harm to the patient, or others. | Class II | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Agfa N.V. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain