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Helax AB
FDA Regulatory Profile
Summary
Total Recalls
0
510(k) Clearances
3
Inspections
0
Compliance Actions
0
Recent 510(k) Clearances
K-Number
Device
Date
K993766
HELAX-TMS V 5.0 RADIATION THERAPY TREATMENT PLANNING SYSTEM
December 8, 1999
K982857
HELAX-IMCON, VERSION 1.0
November 4, 1998
K972617
HELAX-VISIR
October 1, 1997