FDA-Device2025-12-31Class II
Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800
AGFA Healthcare Corp.
Hazard
It is possible to exceed the maximum allowed Air Kerma rate (AKR) of 88mGy/min for pulsed fluoro exams. This can happen in case the framerate is increased on the NX workstation when ABS is not enabled.
Sold states
U.S. Nationwide distribution.
Affected count
35
Manufactured in
10 S Academy St, N/A, Greenville, SC, United States
Products
Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0923-2026Don't want to check this manually?
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