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FDA 510(k)

AMALGA PACS

K-Number: K023246 · 2002-12-23

ApplicantGlobal Care Solutions, S.A.
Decision Date2002-12-23
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AMALGA PACS is the device name listed in this FDA 510(k) record. The listed applicant is Global Care Solutions, S.A.. It received FDA 510(k) clearance on 2002-12-23 under 510(k) number K023246. 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 AMALGA PACS?

AMALGA PACS is a medical device that received FDA 510(k) clearance on 2002-12-23. The listed applicant is Global Care Solutions, S.A.. The 510(k) number is K023246.

When did AMALGA PACS receive FDA 510(k) clearance?

AMALGA PACS received FDA 510(k) clearance on 2002-12-23, under 510(k) number K023246.

Who is the listed applicant for AMALGA PACS?

The FDA 510(k) record lists Global Care Solutions, S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMALGA PACS?

The FDA product code for AMALGA PACS 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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