Radionics, Inc.
Burlington, MA, US
Radionics, Inc. appears in FDA device records in Burlington, MA. FDA records list 57 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 2 recalls for this company.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Radionics, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Integra Burlington Ma, Inc.510(k), enforcement report, recall
510(k) clearance history
Showing 50 of 57FDA records hold 57 510(k) clearances for Radionics, Inc. between 1982 and 2012. The busiest year on record is 1998, with 13. The most recent is 2012, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1982 | 1 |
| 1984 | 1 |
| 1987 | 3 |
| 1991 | 1 |
| 1992 | 1 |
| 1993 | 5 |
| 1994 | 1 |
| 1995 | 1 |
| 1996 | 5 |
| 1997 | 6 |
| 1998 | 13 |
| 1999 | 10 |
| 2000 | 7 |
| 2003 | 1 |
| 2012 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K113570 | INTEGRA CUSA NXT INFERIOR FOWARD BONE TIP | LFL | Substantially Equivalent | |
| K030697 | RADIONICS SINGLE USE GROUND PAD (DGP-HP) | GEI | Substantially Equivalent | |
| K002773 | NEUROMAP WITH NEURO 100 | GWF | Substantially Equivalent | |
| K001741 | RADIONICS RF DISC CATHETER ELECTRODE SYSTEM | HRX | Substantially Equivalent | |
| K992226 | XDS EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM | JXG | Substantially Equivalent | |
| K001950 | OPTICAL TRACKING SYSTEM (OTS) | HAW | Substantially Equivalent | |
| K001700 | XPLAN 2.1 | MUJ | Substantially Equivalent | |
| K001431 | MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS) | HAW | Substantially Equivalent | |
| K000057 | RADIONICS LUMBOPERITONEAL SHUNT | JXG | Substantially Equivalent | |
| K993594 | CONFORMAX MMLC VR1 | IYE | Substantially Equivalent | |
| K991399 | RADIONICS MICROELECTRODE KIT | GXI | Substantially Equivalent | |
| K992721 | COSMAN ROBERT WELLS FUNCTIONAL PROBE MICRODRIVE | HAW | Substantially Equivalent | |
| K992379 | RADIONICS XDC EXTERNAL VENTRICULAR CATHETER | JXG | Substantially Equivalent | |
| K991237 | XPLAN-2 WITH HEAD AND NECK LOCALIZER, MODEL HNL | MUJ | Substantially Equivalent | |
| K991523 | TLC PEDIATRIC FRAME, MODEL TLC-SYS | IYE | Substantially Equivalent | |
| K990632 | OPTICAL TRACKING SYSTEM (OTS) | HAW | Substantially Equivalent | |
| K980903 | RADIONICS EQUI-FLOW VALVE, VENTRICULAR AND PERITONEAL CATHETER WITH EZ-COAT | JXG | Substantially Equivalent | |
| K984552 | COOL-TIP RF SYSTEM | GEI | Substantially Equivalent | |
| K990071 | IMAGEFUSION 2.0 | MUJ | Substantially Equivalent | |
| K982549 | RADIONICS MINI MULTI-LEAF COLLIMATOR, MODEL RADIONICS MMLC | IYE | Substantially Equivalent | |
| K984245 | NON-INVASIVE DYNAMIC REFERENCE FRAME (DRF) FOR OPTICAL TRACKING SYSTEM, MODEL OTS | HAW | Substantially Equivalent | |
| K981820 | NEUROMAP | GZL | Substantially Equivalent | |
| K983669 | OPTICAL TRACKING SYSTEM WITH SURFACE MATCHING MODULE, MODEL OTS | HAW | Substantially Equivalent | |
| K983603 | REFLECTIVE SPHERE STANDARD PROBE AND REFLECTIVE SPHERE DYNAMIC REFERENCE FRAME | HAW | Substantially Equivalent | |
| K981597 | RADIONICS SLICE EDITOR IMAGING SOFTWARE UTILITY | IYE | Substantially Equivalent | |
| K982489 | RFG-3C PLUS | GXD | Substantially Equivalent | |
| K981055 | XKNIFE-4 | IYE | Substantially Equivalent | |
| K982364 | WIRELESS STANDARD PROBE, DYNAMIC REFERENCE FRAME (DRF) | HAW | Substantially Equivalent | |
| K981213 | UNIVERSAL INSTRUMENT REGISTRATION (UIR) MICROSCOPE MODULE I | HAW | Substantially Equivalent | |
| K980584 | ATLASPLAN | HAW | Substantially Equivalent | |
| K980448 | MODEL PS-1 PENA MUSCLE STIMULATOR | IPF | Substantially Equivalent | |
| K980430 | RADIONICS DISPOSABLE RF CANNULAE (SC-C, RFK-DB, RFK-DS) | GXI | Substantially Equivalent | |
| K973297 | COSMAN COAGULATOR (CC-1) SYSTEM | GEI | Substantially Equivalent | |
| K961942 | EPIDURAL PEG ELECTRODE (EP), SPHENOIDAL ELECTRODE (EDS) AND FORAMEN, OVALE DEPTH ELECTRODE (ED-FO) FOR EPILEPSY MONITORI | GYC | Substantially Equivalent | |
| K971511 | RADIONICS CONTOUR FLEX VALVE, RADIONICS CONTOUR FLEX PLUS VALVE | JXG | Substantially Equivalent | |
| K970578 | RADIONICS BURR HOLE VALVE | JXG | Substantially Equivalent | |
| K965182 | RFG-3CF | GXD | Substantially Equivalent | |
| K964386 | RADIONICS CONTOUR FLEX PLUS VALVE | JXG | Substantially Equivalent | |
| K963577 | RADIONICS SLUIJTER-MEHTA CANNULA | GXD | Substantially Equivalent | |
| K963579 | PACE-1A CARDIAC STIMULATOR | JOQ | Substantially Equivalent | |
| K962990 | RADIONICS SIPHON LIMITING DEVICE (SLD) | JXG | Substantially Equivalent | |
| K961858 | COSGROVE DEPTH ELECTRODE KIT(CDEK) | HAW | Substantially Equivalent | |
| K954285 | CONTOUR FLEX VALVES (REGULAR & SMALL) | JXG | Substantially Equivalent | |
| K934523 | GILL-THOMAS-COSMAN (GTC) RELOCATABLE HEAD HOLDER SYSTEM WITH DEPTH CONFIRMATION HELMET(DH-1) | IYE | Substantially Equivalent | |
| K940466 | TITANIUM BIPOLAR FORCEPS | GEI | Substantially Equivalent | |
| K923697 | RADIONUCLIDE CATHETERS, RNC-A, RNC-G, RNC-U | KXK | Substantially Equivalent | |
| K934391 | V/P AND L/P CATHETER PASSERS | GYK | Substantially Equivalent | |
| K926424 | CORTICAL SURF EPILEPSY ELECT DEPTH ELEC EPILEP MON | GYC | Substantially Equivalent | |
| K924226 | OJEMANN CORTICAL STIMULATOR | GYC | Substantially Equivalent | |
| K924632 | LCM-2-LINAC COUCH-MOUNT SYSTEM | IYE | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- IYEAccelerator, Linear, Medical
- HRXArthroscope
- GYCElectrode, Cortical
- GZLElectrode, Depth
- JOTElectrode, Gel, Electrosurgical
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- GXDGenerator, Lesion, Radiofrequency
- JOQGenerator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)
- GYKInstrument, Shunt System Implantation
- LFLInstrument, Ultrasonic Surgical
- HAWNeurological Stereotaxic Instrument
- GXIProbe, Radiofrequency Lesion
- JXGShunt, Central Nervous System And Components
- KXKSource, Brachytherapy, Radionuclide
- GWFStimulator, Electrical, Evoked Response
- IPFStimulator, Muscle, Powered
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
- MUJSystem, Planning, Radiation Therapy Treatment
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1030-2013 | Integra Ojemann Cortical Stimulator; Product / Catalogue No: OCS2. Intended for intraoperative cortical stimulation mapping procedures. | If the headphone jack is in use during a surgical procedure with the OCS2 and a non-intended voltage (such as static electricity) comes in contact with the outer case of the unit, that voltage could be transmitted to the patient and could be a potential source of injury. | Class II | Terminated | |
| Z-1020-04 | Radionics Head and Neck Localilizer (HNL), Version B | Software may provide inaccurate coordinates and cause mistreatment | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain