NOVAPACS— 510(k) K132853

Substantially Equivalent

Novarad Corp.

FDA 510(k) clearance K132853 for NOVAPACS, Substantially Equivalent on 2014-10-30. Applicant: Novarad Corp..

Clearance details

Applicant: Novarad Corp.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2013-09-12
Decision date: 2014-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: American Fork, UT, 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.