Medical Device Manufacturer · SE , Uppsala

Helax AB - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 1997

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Helax AB Radiology ✕

3 devices

1-3 of 3

Cleared Dec 08, 1999

HELAX-TMS V 5.0 RADIATION THERAPY TREATMENT PLANNING SYSTEM

Radiology · 30d

Cleared Nov 04, 1998

HELAX-IMCON, VERSION 1.0

Radiology · 83d

Cleared Oct 01, 1997

Radiology · 84d