NovaPACS, NovaView, NovaCardio, NovaQC, and NovaER
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K061920 FDA 510(k)
- FDA Product Code
- LLZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2050 FDA 510(k)
- Regulation Number
- 892.2050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The NovaPACS, NovaView, NovaCardio, NovaQC, and NovaER are Picture Archiving and Communication Systems (PACS) designed for radiology applications. These systems facilitate the digital storage, retrieval, and distribution of medical imaging studies, enabling efficient workflows in diagnostic and treatment planning environments.
These devices are supplied as Class II medical devices under the FDA’s product code LLZ and are intended for use in radiology settings. Cleared under 510(k) K061920 in 2006, they are substantially equivalent to predicate devices and are regulated as traditional submissions. No specific sterility or single-use/reusable designation is stated in the data.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Novapacs, Novaview, Novacardio, Novaqc and Novaer, Novarad Novapacs, Novaview, Novacardio, Novaqc And Novaer, fda.innolitics.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K061920 | Class II | Active |
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Manufacturer
- Manufacturer
- Novarad Corporation
- FDA Applicant
- Novarad Corp.
Sources (1)
- FDA 510(k) K061920 24 fields · synced Sep 19, 2026