FDA-Device2019-08-07Class II
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 projec
Agfa N.V.
Hazard
The exposed area of fluo exams possibly does not match the active area of the detector within specified limits.
Sold states
US Nationwide Distribution
Affected count
4
Manufactured in
Septestraat 27, N/A, Mortsel, N/A, Belgium
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2056-2019Don't want to check this manually?
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