MODEL-BASED RSA SOFTWARE— 510(k) K133966

Substantially Equivalent

Halifax Biomedical, Inc.

FDA 510(k) clearance K133966 for MODEL-BASED RSA SOFTWARE, Substantially Equivalent on 2014-03-06. Applicant: Halifax Biomedical, Inc..

Clearance details

Applicant: Halifax Biomedical, Inc.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2013-12-24
Decision date: 2014-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Naples, FL, US

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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.