Data / Medical devices / Germany / Agfa-Gevaert Healthcare GMBH
Agfa-Gevaert Healthcare GMBH: FDA-registered device maker in PEISSENBERG Bavaria, Germany, 16 510(k) clearances
Agfa-Gevaert Healthcare GMBH is registered with the FDA (registration 9613152) in PEISSENBERG Bavaria, Germany. It lists 6 device types. The FDA files 16 510(k) clearances under its listings, the newest dated November 18, 2021. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 9613152
- FEI number
- 3003772616
- Address
- Max Planck Strasse 1, PEISSENBERG Bavaria, Germany, D82380
- Owner or operator
- Agfa N.V. (10058267)
- Roles
- Manufacturer
- First device listed
- August 31, 2018
- Registered through
- 2026
- Brand names listed
- Auto QC2 Mammography, CR 10-X, CR 12-X, CR 15-X, CR 25 Digitizer, CR 30-X, CR 85-X, CR Advanced Reader and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Camera, Multi Format, Radiological | LMC | 2 | Manufacturer | accessdata.fda.gov |
| Full Field Digital, System, X-Ray, Mammographic | MUE | 2 | Manufacturer | accessdata.fda.gov |
| Instrument, Quality-Assurance, Radiologic | LHO | 1 | Manufacturer | accessdata.fda.gov |
| Radiology-Diagnostic Kit | OIP | 2 | Manufacturer | accessdata.fda.gov |
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | 2 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Tomographic | IZF | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 18, 2021 | K213469 | VALORY | MQB | Substantially Equivalent | Agfa N.V. | accessdata.fda.gov |
| March 9, 2020 | K193262 | DR 600 with Tomosynthesis | IZF | Substantially Equivalent | Agfa N.V. | accessdata.fda.gov |
| September 22, 2016 | K161368 | DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s) | MQB | Substantially Equivalent | Agfa Healthcare N.V. | accessdata.fda.gov |
| December 11, 2015 | K152639 | DR 600 | MQB | Substantially Equivalent | Agfa Healthcare N.V. | accessdata.fda.gov |
| June 6, 2014 | K141192 | DR 400 | MQB | Substantially Equivalent | Agfa Healthcare N.V. | accessdata.fda.gov |
| August 29, 2013 | K131408 | CR 12-X DIGITIZER | MQB | Substantially Equivalent | Agfa Healthcare N.V. | accessdata.fda.gov |
| July 20, 2012 | K121948 | CR 10-X DIGITIZER | MQB | Substantially Equivalent | Agfa Healthcare N.V. | accessdata.fda.gov |
| December 22, 2011 | K111324 | CR MAMMOGRAPHY SYSTEM WITH DX-M DIGITIZER | MUE | Substantially Equivalent | Agfa Healthcare N.V. | accessdata.fda.gov |
| August 11, 2009 | K092238 | AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH DX-G DIGITIZERS | MQB | Substantially Equivalent | Agfa Healthcare N.V. | accessdata.fda.gov |
| May 18, 2009 | K090672 | AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX WORKSTATIONS | MQB | Substantially Equivalent | Agfa Healthcare N.V. | accessdata.fda.gov |
| October 25, 2007 | K072680 | DRYSTAR AXYS, MODEL EYZ4E | LMC | Substantially Equivalent | Agfa Healthcare Corporation | accessdata.fda.gov |
| October 13, 2006 | K062742 | CR 85-X | MQB | Substantially Equivalent | Agfa Corporation | accessdata.fda.gov |
| September 1, 2006 | K062223 | AGFA MODEL CR30-X | MQB | Substantially Equivalent | Agfa Corporation | accessdata.fda.gov |
| July 22, 2004 | K041701 | AFGA CR25.0 COMPUTED RADIOGRAPHY SYSTEM | MQB | Substantially Equivalent | Agfa Corp. | accessdata.fda.gov |
| September 24, 2003 | K032635 | DRYSTAR 5300 MEDICAL IMAGE PRINTER, MODEL 5300 | LMC | Substantially Equivalent | Agfa Corp. | accessdata.fda.gov |
| October 22, 2002 | K023287 | DRYSTAR 5500 | LMC | Substantially Equivalent | Agfa Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Instrument, Quality-Assurance, Radiologic
- All makers of Solid State X-Ray Imager (Flat Panel/Digital Imager)
- All makers of Radiology-Diagnostic Kit
- All makers of System, X-Ray, Tomographic
- All makers of Camera, Multi Format, Radiological
- All makers of Full Field Digital, System, X-Ray, Mammographic
Updated November 18, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.