NovaPACS— 510(k) K160371

Substantially Equivalent

Novarad Corporation

FDA 510(k) clearance K160371 for NovaPACS, Substantially Equivalent on 2016-10-14. Applicant: Novarad Corporation.

Clearance details

Applicant: Novarad Corporation
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2016-02-10
Decision date: 2016-10-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: American Fork, UT, US

Download summary PDF View on FDA.gov ↗

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.