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FDA 510(k)

NOVAPACS

K-Number: K063153 · 2006-12-07

ApplicantNovarad Corp.
Decision Date2006-12-07
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

NOVAPACS is the device name listed in this FDA 510(k) record. The listed applicant is Novarad Corp.. It received FDA 510(k) clearance on 2006-12-07 under 510(k) number K063153. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NOVAPACS?

NOVAPACS is a medical device that received FDA 510(k) clearance on 2006-12-07. The listed applicant is Novarad Corp.. The 510(k) number is K063153.

When did NOVAPACS receive FDA 510(k) clearance?

NOVAPACS received FDA 510(k) clearance on 2006-12-07, under 510(k) number K063153.

Who is the listed applicant for NOVAPACS?

The FDA 510(k) record lists Novarad Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NOVAPACS?

The FDA product code for NOVAPACS is LLZ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Novarad Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K061920NOVAPACS, NOVAVIEW, NOVACARDIO, NOVAQC AND NOVAER

Related Devices (Code: LLZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261874Syneris PACS v.1.0.1.0SynerisK262442HipStudio AnalysisReplasia BVK261855Elucid PlaqueIQElucid Bioimaging, Inc.K254214OOOPDSTaiwan Main Orthopaedic Biotechnology Co., Ltd.K261861SPINEsim v1.0Mdsim S.A.K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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