510(k) Report

FDA applicant

Radionics Software Applications, Inc.

Burlington, MA12 decisions1993–19994 recalls

FDA records 12 decisions for Radionics Software Applications, Inc. (Burlington, MA) from 1993 to 1999: 12 510(k) clearances. Most are in product codes HAW (Neurological Stereotaxic Instrument) and IYE (Accelerator, Linear, Medical). Its devices cite 10 predicates, 4 of them its own earlier devices. 4 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided Radionics Software Applications, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Radionics Software Applications, Inc. since 2007.

Recalls per year

1in 2015

2011: 12012: 22015: 1
2007high 2 (2012) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Radionics Software Applications, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Radionics Software Applications, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • HAWNeurological Stereotaxic Instrument6decisions
  • IYEAccelerator, Linear, Medical4decisions
  • LLZSystem, Image Processing, Radiological2decisions

Whose devices does it build on?

Its devices cite 10 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 26 times; 4 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K951262Operating Arm System (Oas)Radionics Software Applications, Inc. · 19954cite it
  • K961844Operating Arm System (Oas) [with CT and MR Images]Radionics Software Applications, Inc. · 19963cite it
  • K960071ImagefusionRadionics Software Applications, Inc. · 19963cite it
  • K953482Xknife-3Radionics Software Applications, Inc. · 19953cite it
  • K962155Gill-Thomas-Cosman (GTC) Dental TrayRadionics Software Applications, Inc. · 19962cite it
  • K944463CRW-1 SystemRadionics Software Applications, Inc. · 19952cite it

What has FDA decided for it lately?

  • K990326Optical Tracking System Microscope Module II, Model Ots MmiiRadionics Software Applications, Inc. · 1999
  • K974602Optical Tracking System (Ots)Radionics Software Applications, Inc. · 1998
  • K972905XPLAN-1Radionics Software Applications, Inc. · 1997
  • K964801Optical Tracking System (Ots)Radionics Software Applications, Inc. · 1997
  • K961844Operating Arm System (Oas) [with CT and MR Images]Radionics Software Applications, Inc. · 1996
  • K962155Gill-Thomas-Cosman (GTC) Dental TrayRadionics Software Applications, Inc. · 1996
  • K960071ImagefusionRadionics Software Applications, Inc. · 1996
  • K951262Operating Arm System (Oas)Radionics Software Applications, Inc. · 1995

All 12 as Radionics Software Applications, Inc. →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K944463Universal Compact Head Ring Adapter Plate (UCHRAP), a component of the Universal Compact…Aug 21, 2015Class II
  • K944463Integra CRW Precision Arc (CRWPRECISE), CRW Arc System (CRWASL), HRAIM Head Ring…Aug 9, 2012Class II
  • K944463Integra HRAIM Head Ring Assembly with Intubation Mounts The CRW stereotactic system is…Aug 9, 2012Class II
  • K944463Integra Radionics HRAIM Intubation Head Ring Assembly Ref: HRAIM Head Rings serve as the…Jan 12, 2011

Other applicant names beginning “Radionics”

FDA records each applicant name separately; these may or may not be the same firm.

Radionics, Inc. 56Radionics, A Division of Tyco Healthcare Group LP 8Radionics Medical, Inc. 5