Company ยท US
Radionics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1982 to 2003. Name variants (Inc, Corp, punctuation) are merged.
56510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HAW | Neurological Stereotaxic Instrument | 11 |
| JXG | Shunt, Central Nervous System And Components | 10 |
| IYE | Accelerator, Linear, Medical | 7 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 6 |
| GXD | Generator, Lesion, Radiofrequency | 4 |
| MUJ | System, Planning, Radiation Therapy Treatment | 4 |
| GXI | Probe, Radiofrequency Lesion | 3 |
| GYC | Electrode, Cortical | 3 |
| GWF | Stimulator, Electrical, Evoked Response | 1 |
| GYK | Instrument, Shunt System Implantation | 1 |
| GZL | Electrode, Depth | 1 |
| HRX | Arthroscope | 1 |
| IPF | Stimulator, Muscle, Powered | 1 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 1 |
| JOQ | Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only) | 1 |
| JOT | Electrode, Gel, Electrosurgical | 1 |
| KXK | Source, Brachytherapy, Radionuclide | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 4, 2003 | K030697 | RADIONICS SINGLE USE GROUND PAD (DGP-HP) Radionics, Inc. | GEI |
| Oct 23, 2000 | K002773 | NEUROMAP WITH NEURO 100 Radionics, Inc. | GWF |
| Oct 23, 2000 | K001741 | RADIONICS RF DISC CATHETER ELECTRODE SYSTEM Radionics, Inc. | HRX |
| Aug 4, 2000 | K992226 | XDS EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM Radionics, Inc. | JXG |
| Jul 26, 2000 | K001950 | OPTICAL TRACKING SYSTEM (OTS) Radionics, Inc. | HAW |
| Jun 28, 2000 | K001700 | XPLAN 2.1 Radionics, Inc. | MUJ |
| May 17, 2000 | K001431 | MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS) Radionics, Inc. | HAW |
| Mar 20, 2000 | K000057 | RADIONICS LUMBOPERITONEAL SHUNT Radionics, Inc. | JXG |
| Dec 15, 1999 | K993594 | CONFORMAX MMLC VR1 Radionics, Inc. | IYE |
| Sep 21, 1999 | K991399 | RADIONICS MICROELECTRODE KIT Radionics, Inc. | GXI |
| Sep 10, 1999 | K992721 | COSMAN ROBERT WELLS FUNCTIONAL PROBE MICRODRIVE Radionics, Inc. | HAW |
| Sep 8, 1999 | K992379 | RADIONICS XDC EXTERNAL VENTRICULAR CATHETER Radionics, Inc. | JXG |
| Aug 30, 1999 | K991237 | XPLAN-2 WITH HEAD AND NECK LOCALIZER, MODEL HNL Radionics, Inc. | MUJ |
| Jul 30, 1999 | K991523 | TLC PEDIATRIC FRAME, MODEL TLC-SYS Radionics, Inc. | IYE |
| Apr 29, 1999 | K990632 | OPTICAL TRACKING SYSTEM (OTS) Radionics, Inc. | HAW |
| Apr 19, 1999 | K980903 | RADIONICS EQUI-FLOW VALVE, VENTRICULAR AND PERITONEAL CATHETER WITH EZ-COAT Radionics, Inc. | JXG |
| Mar 5, 1999 | K984552 | COOL-TIP RF SYSTEM Radionics, Inc. | GEI |
| Feb 8, 1999 | K990071 | IMAGEFUSION 2.0 Radionics, Inc. | MUJ |
| Dec 30, 1998 | K982549 | RADIONICS MINI MULTI-LEAF COLLIMATOR, MODEL RADIONICS MMLC Radionics, Inc. | IYE |
| Dec 18, 1998 | K984245 | NON-INVASIVE DYNAMIC REFERENCE FRAME (DRF) FOR OPTICAL TRACKING SYSTEM, MODEL OTS Radionics, Inc. | HAW |
| Nov 20, 1998 | K981820 | NEUROMAP Radionics, Inc. | GZL |
| Nov 18, 1998 | K983669 | OPTICAL TRACKING SYSTEM WITH SURFACE MATCHING MODULE, MODEL OTS Radionics, Inc. | HAW |
| Nov 10, 1998 | K983603 | REFLECTIVE SPHERE STANDARD PROBE AND REFLECTIVE SPHERE DYNAMIC REFERENCE FRAME Radionics, Inc. | HAW |
| Oct 9, 1998 | K981597 | RADIONICS SLICE EDITOR IMAGING SOFTWARE UTILITY Radionics, Inc. | IYE |
| Oct 5, 1998 | K982489 | RFG-3C PLUS Radionics, Inc. | GXD |
| Sep 29, 1998 | K981055 | XKNIFE-4 Radionics, Inc. | IYE |
| Aug 5, 1998 | K982364 | WIRELESS STANDARD PROBE, DYNAMIC REFERENCE FRAME (DRF) Radionics, Inc. | HAW |
| Jul 1, 1998 | K981213 | UNIVERSAL INSTRUMENT REGISTRATION (UIR) MICROSCOPE MODULE I Radionics, Inc. | HAW |
| May 18, 1998 | K980584 | ATLASPLAN Radionics, Inc. | HAW |
| Apr 3, 1998 | K980448 | MODEL PS-1 PENA MUSCLE STIMULATOR Radionics, Inc. | IPF |
| Mar 16, 1998 | K980430 | RADIONICS DISPOSABLE RF CANNULAE (SC-C, RFK-DB, RFK-DS) Radionics, Inc. | GXI |
| Oct 29, 1997 | K973297 | COSMAN COAGULATOR (CC-1) SYSTEM Radionics, Inc. | GEI |
| Aug 18, 1997 | K961942 | EPIDURAL PEG ELECTRODE (EP), SPHENOIDAL ELECTRODE (EDS) AND FORAMEN, OVALE DEPTH ELECTRODE (ED-FO) FOR EPILEPSY MONITORI Radionics, Inc. | GYC |
| Jul 24, 1997 | K971511 | RADIONICS CONTOUR FLEX VALVE, RADIONICS CONTOUR FLEX PLUS VALVE Radionics, Inc. | JXG |
| Jun 4, 1997 | K970578 | RADIONICS BURR HOLE VALVE Radionics, Inc. | JXG |
| Mar 12, 1997 | K965182 | RFG-3CF Radionics, Inc. | GXD |
| Jan 31, 1997 | K964386 | RADIONICS CONTOUR FLEX PLUS VALVE Radionics, Inc. | JXG |
| Nov 21, 1996 | K963577 | RADIONICS SLUIJTER-MEHTA CANNULA Radionics, Inc. | GXD |
| Nov 8, 1996 | K963579 | PACE-1A CARDIAC STIMULATOR Radionics, Inc. | JOQ |
| Oct 23, 1996 | K962990 | RADIONICS SIPHON LIMITING DEVICE (SLD) Radionics, Inc. | JXG |
| Aug 7, 1996 | K961858 | COSGROVE DEPTH ELECTRODE KIT(CDEK) Radionics, Inc. | HAW |
| Jan 26, 1996 | K954285 | CONTOUR FLEX VALVES (REGULAR & SMALL) Radionics, Inc. | JXG |
| Feb 8, 1995 | K934523 | GILL-THOMAS-COSMAN (GTC) RELOCATABLE HEAD HOLDER SYSTEM WITH DEPTH CONFIRMATION HELMET(DH-1) Radionics, Inc. | IYE |
| Apr 21, 1994 | K940466 | TITANIUM BIPOLAR FORCEPS Radionics, Inc. | GEI |
| Dec 13, 1993 | K923697 | RADIONUCLIDE CATHETERS, RNC-A, RNC-G, RNC-U Radionics, Inc. | KXK |
| Nov 19, 1993 | K934391 | V/P AND L/P CATHETER PASSERS Radionics, Inc. | GYK |
| Nov 19, 1993 | K926424 | CORTICAL SURF EPILEPSY ELECT DEPTH ELEC EPILEP MON Radionics, Inc. | GYC |
| Apr 21, 1993 | K924226 | OJEMANN CORTICAL STIMULATOR Radionics, Inc. | GYC |
| Apr 7, 1993 | K924632 | LCM-2-LINAC COUCH-MOUNT SYSTEM Radionics, Inc. | IYE |
| Nov 9, 1992 | K923647 | RFG-DGP DISPOSABLE GROUNDING PADS Radionics, Inc. | JOT |
Newest 50 of 56.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Radionics, Inc. Radionics Head and Neck Localilizer (HNL), Version B Terminated |
MUJ | K991237 |