IWB · Class II · 21 CFR 892.5750

FDA Product Code IWB: System, Radiation Therapy, Radionuclide

Leading manufacturers include Elekta Instrument AB, Akesis, Inc. and Elekta Solutions AB.

48
Total
48
Cleared
126d
Avg days
1978
Since
48 devices
25–48 of 48
Cleared Dec 30, 2004
MASEP SRRS GAMMA RAYS STEREOTACTIC RADIATION THERAPY SYSTEM FOR HEADS (MASEP GAMMA THERAPY SYSTEM)
K041125
Masep Med Science & Tech. Development (Shenzhen) C
Radiology · 244d
Cleared Jul 14, 1999
THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY
K984563
Accuray, Inc.
Radiology · 203d
Cleared May 21, 1999
LEKSELL GAMMA KNIFE TARGET SYSTEM, MODEL 24001
K984328
Elekta Instrument AB
Radiology · 169d
Cleared Dec 04, 1998
THERATRON ELITE
K983917
Theratronics, Inc.
Radiology · 30d
Cleared Apr 01, 1998
LEKSELL GAMMAPLAN
K973441
Patterson Consulting Group, Inc.
Radiology · 202d
Cleared Jun 26, 1997
THERATRON 780E
K964606
Theratronics, Inc.
Radiology · 220d
Cleared May 20, 1997
OUR ROTATING GAMMA SYSTEM
K970647
Our Scientific Intl., Inc.
Radiology · 89d
Cleared Jun 03, 1996
THE COBALT SCALPEL
K960892
Nova Therapeutic System
Radiology · 90d
Cleared Apr 06, 1987
DISPOSABLE SHADOW TRAY INSERTS
K871215
Mick Radio-Nuclear Instruments, Inc.
Radiology · 11d