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FDA 510(k)

PAXERAPACS

K-Number: K132586 · 2013-10-31

ApplicantPaxeramed
Decision Date2013-10-31
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PAXERAPACS is the device name listed in this FDA 510(k) record. The listed applicant is Paxeramed. It received FDA 510(k) clearance on 2013-10-31 under 510(k) number K132586. 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 PAXERAPACS?

PAXERAPACS is a medical device that received FDA 510(k) clearance on 2013-10-31. The listed applicant is Paxeramed. The 510(k) number is K132586.

When did PAXERAPACS receive FDA 510(k) clearance?

PAXERAPACS received FDA 510(k) clearance on 2013-10-31, under 510(k) number K132586.

Who is the listed applicant for PAXERAPACS?

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

What is the FDA product code for PAXERAPACS?

The FDA product code for PAXERAPACS is LLZ.

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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

View on FDA Database →

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

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