Radionics, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
56
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K030697RADIONICS SINGLE USE GROUND PAD (DGP-HP)April 4, 2003
K001741RADIONICS RF DISC CATHETER ELECTRODE SYSTEMOctober 23, 2000
K002773NEUROMAP WITH NEURO 100October 23, 2000
K992226XDS EXTERNAL CSF DRAINAGE AND MONITORING SYSTEMAugust 4, 2000
K001950OPTICAL TRACKING SYSTEM (OTS)July 26, 2000
K001700XPLAN 2.1June 28, 2000
K001431MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS)May 17, 2000
K000057RADIONICS LUMBOPERITONEAL SHUNTMarch 20, 2000
K993594CONFORMAX MMLC VR1December 15, 1999
K991399RADIONICS MICROELECTRODE KITSeptember 21, 1999
K992721COSMAN ROBERT WELLS FUNCTIONAL PROBE MICRODRIVESeptember 10, 1999
K992379RADIONICS XDC EXTERNAL VENTRICULAR CATHETERSeptember 8, 1999
K991237XPLAN-2 WITH HEAD AND NECK LOCALIZER, MODEL HNLAugust 30, 1999
K991523TLC PEDIATRIC FRAME, MODEL TLC-SYSJuly 30, 1999
K990632OPTICAL TRACKING SYSTEM (OTS)April 29, 1999
K980903RADIONICS EQUI-FLOW VALVE, VENTRICULAR AND PERITONEAL CATHETER WITH EZ-COATApril 19, 1999
K984552COOL-TIP RF SYSTEMMarch 5, 1999
K990071IMAGEFUSION 2.0February 8, 1999
K982549RADIONICS MINI MULTI-LEAF COLLIMATOR, MODEL RADIONICS MMLCDecember 30, 1998
K984245NON-INVASIVE DYNAMIC REFERENCE FRAME (DRF) FOR OPTICAL TRACKING SYSTEM, MODEL OTSDecember 18, 1998