NOVAPACS— 510(k) K063153

Name: FDA 510(k) clearance K063153
Creator: U.S. Food and Drug Administration
Published: 2006-12-07

Substantially Equivalent

Novarad Corp.

FDA 510(k) clearance K063153 for NOVAPACS, Substantially Equivalent on 2006-12-07. 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: 2006-10-16
Decision date: 2006-12-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: American Fork, UT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLZ

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More clearances from Novarad Corp.

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K132853 — NOVAPACS2014-10-30
K061920 — NOVAPACS, NOVAVIEW, NOVACARDIO, NOVAQC AND NOVAER2006-08-21

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 →

Recalls naming K063153

K-number listed on FDA's recall record

Z-2151-2016 — NovaPACS versions 7.4, 7.5, 7.6, and 8.0, Diagnostic Viewer. Distributed by Novarad Corporation. Picture archiving and communication system (PACS)Class II·Terminated·Novarad Corporation·20130509

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K063153.

Data sourced from openFDA. This site is unofficial and independent of the FDA.