NOVAPACS, NOVAVIEW, NOVACARDIO, NOVAQC AND NOVAER— 510(k) K061920

Name: FDA 510(k) clearance K061920
Creator: U.S. Food and Drug Administration
Published: 2006-08-21

Substantially Equivalent

Novarad Corp.

FDA 510(k) clearance K061920 for NOVAPACS, NOVAVIEW, NOVACARDIO, NOVAQC AND NOVAER, Substantially Equivalent on 2006-08-21. Applicant: Novarad Corp.. Device class: 2.

Clearance details

Applicant: Novarad Corp.
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2006-07-06
Decision date: 2006-08-21
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.