# Radionics, Inc.

- Location (FDA's records): Burlington, MA
- FDA decisions: 56 (1982–2003): 56 510(k) clearances
- Product codes: HAW (11), JXG (10), IYE (7), GEI (6), GXD (4), GXI (3), GYC (3), MUJ (3), IPF (1), GZL (1), JOT (1), GYK (1)
- Predicates its devices cite: 29 (9 its own); citations of its devices by later devices: 80 (9 its own)
- Recalls linked to its devices: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Radionics Software Applications, Inc.: 9 (https://510kreport.com/company/radionics-software-applications)
- Surgical Navigation Technologies, Inc.: 3 (https://510kreport.com/company/surgical-navigation-technologies)
- Medical Instrumentation & Diagnostics Corp.(Midco): 3 (https://510kreport.com/company/medical-instrumentation-diagnostics-midco)
- Clinical Neuro Systems, LLC: 1 (https://510kreport.com/company/clinical-neuro-systems)
- Brainlab Med. Computersysteme GmbH: 1 (https://510kreport.com/company/brainlab-med-computersysteme)
- Nikomed U.S.A., Inc.: 1 (https://510kreport.com/company/nikomed-usa)
- Medtronic PS Medical: 1 (https://510kreport.com/company/medtronic-ps-medical)
- Trent Wells, Inc.: 1 (https://510kreport.com/company/trent-wells)

## Firms that cite its devices most
- Radionics, A Division of Tyco Healthcare Group LP: 7 (https://510kreport.com/company/radionics-a-division-of-tyco-healthcare-group)
- Rita Medical Systems: 6 (https://510kreport.com/company/rita-medical-systems)
- Cosman Medical, Inc.: 5 (https://510kreport.com/company/cosman-medical)
- Integra Neurosciences Implants S.A.: 4 (https://510kreport.com/company/integra-neurosciences-implants)
- Elekta Instrument AB: 3 (https://510kreport.com/company/elekta-instrument)
- Technomed Europe: 3 (https://510kreport.com/company/technomed-europe)
- FHC, Inc.: 3 (https://510kreport.com/company/fhc)
- Smith & Nephew, Inc.: 3 (https://510kreport.com/company/smith-nephew)

## Its most-cited devices
- K984552: Cool-Tip RF System (1999), cited by 12
- K870028: SMK Sluyter-Mehta Cannulae, RF Pole, Pole,Flexible (1987), cited by 8
- K980430: Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS) (1998), cited by 7
- K934523: Gill-Thomas-Cosman (GTC) Relocatable Head Holder System with Depth Confirmation Helmet (DH-1) (1995), cited by 6
- K963577: Radionics Sluijter-Mehta Cannula (1996), cited by 6
- K924226: Ojemann Cortical Stimulator (1993), cited by 5

## Recent decisions
- K030697: Radionics Single Use Ground Pad (DGP-HP) (Apr 4, 2003)
- K001741: Radionics RF Disc Catheter Electrode System (Oct 23, 2000)
- K002773: Neuromap with Neuro 100 (Oct 23, 2000)
- K992226: XDS External CSF Drainage and Monitoring System (Aug 4, 2000)
- K001950: Optical Tracking System (Ots) (Jul 26, 2000)
- K001700: XPLAN 2.1 (Jun 28, 2000)
- K001431: Modification to Optical Tracking System (Ots) (May 17, 2000)
- K000057: Radionics Lumboperitoneal Shunt (Mar 20, 2000)

Source page: https://510kreport.com/company/radionics