Helax AB

FDA Regulatory Profile

Helax AB appears in FDA public data with 0 recalls, 3 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on December 8, 1999.

Summary

Total Recalls
0
510(k) Clearances
3
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K993766HELAX-TMS V 5.0 RADIATION THERAPY TREATMENT PLANNING SYSTEMDecember 8, 1999
K982857HELAX-IMCON, VERSION 1.0November 4, 1998
K972617HELAX-VISIROctober 1, 1997