OPTICAL TRACKING SYSTEM WITH SURFACE MATCHING MODULE, MODEL OTS— 510(k) K983669

Substantially Equivalent

Radionics, Inc.

FDA 510(k) clearance K983669 for OPTICAL TRACKING SYSTEM WITH SURFACE MATCHING MODULE, MODEL OTS, Substantially Equivalent on 1998-11-18. Applicant: Radionics, Inc..

Clearance details

Applicant: Radionics, Inc.
Product code: Code HAW
Advisory panel: Neurology
Date received: 1998-10-19
Decision date: 1998-11-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Burlington, MA, US

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Adverse events under product code HAW

product code HAW

Death: 52
Injury: 1,083
Malfunction: 17,300
Total: 18,435

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.