FDA 510(k)

AXIS PACS, HMS PACS

K-Number: K103679 · 2011-03-03

Decision Date2011-03-03

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

AXIS PACS, HMS PACS is the device name listed in this FDA 510(k) record. The listed applicant is Axis Health Care, LLC. It received FDA 510(k) clearance on 2011-03-03 under 510(k) number K103679. 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 AXIS PACS, HMS PACS?

AXIS PACS, HMS PACS is a medical device that received FDA 510(k) clearance on 2011-03-03. The listed applicant is Axis Health Care, LLC. The 510(k) number is K103679.

When did AXIS PACS, HMS PACS receive FDA 510(k) clearance?

AXIS PACS, HMS PACS received FDA 510(k) clearance on 2011-03-03, under 510(k) number K103679.

Who is the listed applicant for AXIS PACS, HMS PACS?

The FDA 510(k) record lists Axis Health Care, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AXIS PACS, HMS PACS?

The FDA product code for AXIS PACS, HMS PACS is LLZ.

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.1.0.1.0Syneris K262442HipStudio AnalysisReplasia BV K261855Elucid 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.