FDA-Device2025-10-08Class II
Ashvins variant HEYEX 2 / HEYEX PACS. Software Version: Version 2.6.0 (Build 2088) to 2.6.8 (Build 2220). Device Type: Software (Medical Image Management, Picture Archiving and Communication System)
Hazard
Potential that the measured value may be smaller than the actual area.
Sold states
US Nationwide distribution.
Affected count
474 units
Manufactured in
Max-Jarecki-Str. 8, N/A, Heidelberg, N/A, Germany
Products
Ashvins variant HEYEX 2 / HEYEX PACS. Software Version: Version 2.6.0 (Build 2088) to 2.6.8 (Build 2220). Device Type: Software (Medical Image Management, Picture Archiving and Communication System)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2673-2025Want us to check the next one for you?
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