Radionics, Inc.
Medical device manufacturer in Burlington, MA.
56510(k) clearances
0PMA approvals
0recalls
Device types
- HAW Neurological Stereotaxic Instrument 11
- JXG Shunt, Central Nervous System And Components 10
- IYE Accelerator, Linear, Medical 7
- GEI Electrosurgical, Cutting & Coagulation &… 6
- GXD Generator, Lesion, Radiofrequency 4
- GXI Probe, Radiofrequency Lesion 3
- GYC Electrode, Cortical 3
- MUJ System, Planning, Radiation Therapy Treatment 3
- GWF Stimulator, Electrical, Evoked Response 1
- IYO System, Imaging, Pulsed Echo, Ultrasonic 1
- HRX Arthroscope 1
- GZL Electrode, Depth 1
- IPF Stimulator, Muscle, Powered 1
- JOQ Generator, Pulse, Pacemaker, External… 1
- KXK Source, Brachytherapy, Radionuclide 1
- GYK Instrument, Shunt System Implantation 1
- JOT Electrode, Gel, Electrosurgical 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K030697 | Radionics Single Use Ground Pad (Dgp-Hp)GEI · Special | 04/04/2003SE |
| K002773 | Neuromap with Neuro 100GWF · Traditional | 10/23/2000SE |
| K001741 | Radionics RF Disc Catheter Electrode SystemHRX · Traditional | 10/23/2000SE |
| K992226 | XDS External CSF Drainage and Monitoring SystemJXG · Traditional | 08/04/2000SE |
| K001950 | Optical Tracking System (Ots)HAW · Special | 07/26/2000SE |
| K001700 | Xplan 2.1MUJ · Special | 06/28/2000SE |
| K001431 | Modification to Optical Tracking System (Ots)HAW · Special | 05/17/2000SE |
| K000057 | Radionics Lumboperitoneal ShuntJXG · Traditional | 03/20/2000SE |
| K993594 | Conformax MMLC VR1IYE · Special | 12/15/1999SE |
| K991399 | Radionics Microelectrode KitGXI · Traditional | 09/21/1999SE |
| K992721 | Cosman Robert Wells Functional Probe MicrodriveHAW · Special | 09/10/1999SE |
| K992379 | Radionics XDC External Ventricular CatheterJXG · Traditional | 09/08/1999SE |
| K991237 | XPLAN-2 with Head and Neck Localizer, Model HNLMUJ · Traditional | 08/30/1999SE |
| K991523 | TLC Pediatric Frame, Model Tlc-SysIYE · Traditional | 07/30/1999SE |
| K990632 | Optical Tracking System (Ots)HAW · Traditional | 04/29/1999SE |
| K980903 | Radionics Equi-Flow Valve, Ventricular and Peritoneal Catheter with Ez-CoatJXG · Traditional | 04/19/1999SE |
| K984552 | Cool-Tip RF SystemGEI · Traditional | 03/05/1999SE |
| K990071 | Imagefusion 2.0MUJ · Special | 02/08/1999SE |
| K982549 | Radionics Mini Multi-Leaf Collimator, Model Radionics MMLCIYE · Traditional | 12/30/1998SE |
| K984245 | Non-Invasive Dynamic Reference Frame (DRF) for Optical Tracking System, Model OtsHAW · Special | 12/18/1998SE |
| K981820 | NeuromapGZL · Traditional | 11/20/1998SE |
| K983669 | Optical Tracking System with Surface Matching Module, Model OtsHAW · Special | 11/18/1998SE |
| K983603 | Reflective Sphere Standard Probe and Reflective Sphere Dynamic Reference FrameHAW · Special | 11/10/1998SE |
| K981597 | Radionics Slice Editor Imaging Software UtilityIYE · Traditional | 10/09/1998SE |
| K982489 | RFG-3C PlusGXD · Traditional | 10/05/1998SE |
| K981055 | XKNIFE-4IYE · Traditional | 09/29/1998SE |
| K982364 | Wireless Standard Probe, Dynamic Reference Frame (DRF)HAW · Special | 08/05/1998SE |
| K981213 | Universal Instrument Registration (Uir) Microscope Module IHAW · Traditional | 07/01/1998SE |
| K980584 | AtlasplanHAW · Traditional | 05/18/1998SE |
| K980448 | Model PS-1 Pena Muscle StimulatorIPF · Traditional | 04/03/1998SE |
| K980430 | Radionics Disposable RF Cannulae (Sc-C, Rfk-Db, Rfk-Ds)GXI · Traditional | 03/16/1998SE |
| K973297 | Cosman Coagulator (CC-1) SystemGEI · Traditional | 10/29/1997SE |
| K961942 | Epidural Peg Electrode (Ep), Sphenoidal Electrode (Eds) and Foramen, Ovale Depth…GYC · Traditional | 08/18/1997SE |
| K971511 | Radionics Contour Flex Valve, Radionics Contour Flex Plus ValveJXG · Traditional | 07/24/1997SE |
| K970578 | Radionics Burr Hole ValveJXG · Traditional | 06/04/1997SE |
| K965182 | RFG-3CFGXD · Traditional | 03/12/1997SE |
| K964386 | Radionics Contour Flex Plus ValveJXG · Traditional | 01/31/1997SE |
| K963577 | Radionics Sluijter-Mehta CannulaGXD · Traditional | 11/21/1996SE |
| K963579 | PACE-1A Cardiac StimulatorJOQ · Traditional | 11/08/1996SE |
| K962990 | Radionics Siphon Limiting Device (SLD)JXG · Traditional | 10/23/1996SE |
| K961858 | Cosgrove Depth Electrode Kit(Cdek)HAW · Traditional | 08/07/1996SE |
| K954285 | Contour Flex Valves (Regular & Small)JXG · Traditional | 01/26/1996SE |
| K934523 | Gill-Thomas-Cosman (GTC) Relocatable Head Holder System with Depth Confirmation…IYE · Traditional | 02/08/1995SE |
| K940466 | Titanium Bipolar ForcepsGEI · Traditional | 04/21/1994SE |
| K923697 | Radionuclide Catheters, Rnc-A, Rnc-G, Rnc-UKXK · Traditional | 12/13/1993SE |
| K934391 | V/P and L/P Catheter PassersGYK · Traditional | 11/19/1993SE |
| K926424 | Cortical Surf Epilepsy Elect Depth Elec Epilep MonGYC · Traditional | 11/19/1993SE |
| K924226 | Ojemann Cortical StimulatorGYC · Traditional | 04/21/1993SE |
| K924632 | LCM-2-LINAC Couch-Mount SystemIYE · Traditional | 04/07/1993SE |
| K923647 | Rfg-Dgp Disposable Grounding PadsJOT · Traditional | 11/09/1992SE |
| K901540 | Model RFG-3C Radiofrequency Lesion GeneratorGXD · Traditional | 04/08/1991SE |
| K870028 | SMK Sluyter-Mehta Cannulae, RF Pole, Pole,FlexibleGXI · Traditional | 10/26/1987SE |
| K871077 | Model CBC-1 Coa Comp Anti-Sticking Bipolar Coag.GEI · Traditional | 06/12/1987SE |
| K870149 | Model CBC-1 Coa-Comp Anti-Sticking Biopolar Coag.GEI · Traditional | 04/06/1987SE |
| K843132 | Radionics Mini & Standard Shunt ValveJXG · Traditional | 09/12/1984SE |
| K820042 | Ocular-Biometer 4000IYO · Traditional | 07/22/1982SE |