510(k) Report

FDA applicant

Radionics Medical, Inc.

Scarborough, Ontario, Can, CA5 decisions1981–19850 recalls

FDA records 5 decisions for Radionics Medical, Inc. (Scarborough, Ontario, Can, CA) from 1981 to 1985: 5 510(k) clearances. Most are in product codes IYO (System, Imaging, Pulsed Echo, Ultrasonic) and DXG (Computer, Diagnostic, Pre-Programmed…). No recall is linked to its devices.

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

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

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

FDA decisions per year

No FDA decision for Radionics Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

See the 510(k) Report

Which product codes does it file in?

  • IYOSystem, Imaging, Pulsed Echo, Ultrasonic2decisions
  • DXGComputer, Diagnostic, Pre-Programmed, Single-Function1decision

What has FDA decided for it lately?

  • K844299Corneomap 4500Radionics Medical, Inc. · 1985
  • K833222Sinusvu 2500Radionics Medical, Inc. · 1983
  • K837331Corneomap 4500 Ultrasound MeasurementRadionics Medical, Inc. · 1983
  • K827035Ocular Biometer 4000Radionics Medical, Inc. · 1982
  • K810851Spectrum Analyzer 8000Radionics Medical, Inc. · 1981

All 5 as Radionics Medical, Inc. →

Other applicant names beginning “Radionics”

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

Radionics, Inc. 56Radionics Software Applications, Inc. 12Radionics, A Division of Tyco Healthcare Group LP 8