IMAGEFUSION— 510(k) K960071

Name: FDA 510(k) clearance K960071
Creator: U.S. Food and Drug Administration
Published: 1996-04-17

Substantially Equivalent

Radionics Software Applications, Inc.

FDA 510(k) clearance K960071 for IMAGEFUSION, Substantially Equivalent on 1996-04-17. Applicant: Radionics Software Applications, Inc.. Device class: 2.

Clearance details

Applicant: Radionics Software Applications, Inc.
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 1996-01-05
Decision date: 1996-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burlington, MA, US

Download summary PDF View on FDA.gov ↗

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K990326 — OPTICAL TRACKING SYSTEM MICROSCOPE MODULE II, MODEL OTS MMII1999-03-04
K974602 — OPTICAL TRACKING SYSTEM (OTS)1998-04-21
K972905 — XPLAN-11997-10-28
K964801 — OPTICAL TRACKING SYSTEM (OTS)1997-06-02
K961844 — OPERATING ARM SYSTEM (OAS) [WITH CT AND MR IMAGES]1996-10-23

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.