OPTICAL TRACKING SYSTEM MICROSCOPE MODULE II, MODEL OTS MMII— 510(k) K990326

Substantially Equivalent

Radionics Software Applications, Inc.

FDA 510(k) clearance K990326 for OPTICAL TRACKING SYSTEM MICROSCOPE MODULE II, MODEL OTS MMII, Substantially Equivalent on 1999-03-04. Applicant: Radionics Software Applications, Inc..

Clearance details

Applicant: Radionics Software Applications, Inc.
Product code: Code HAW
Advisory panel: Neurology
Date received: 1999-02-02
Decision date: 1999-03-04
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.