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FDA 510(k)

PACS PLUS 5TH EDITION

K-Number: K083658 · 2009-07-07

ApplicantMedical Standard Co., Ltd.
Decision Date2009-07-07
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PACS PLUS 5TH EDITION is the device name listed in this FDA 510(k) record. The listed applicant is Medical Standard Co., Ltd.. It received FDA 510(k) clearance on 2009-07-07 under 510(k) number K083658. 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 PACS PLUS 5TH EDITION?

PACS PLUS 5TH EDITION is a medical device that received FDA 510(k) clearance on 2009-07-07. The listed applicant is Medical Standard Co., Ltd.. The 510(k) number is K083658.

When did PACS PLUS 5TH EDITION receive FDA 510(k) clearance?

PACS PLUS 5TH EDITION received FDA 510(k) clearance on 2009-07-07, under 510(k) number K083658.

Who is the listed applicant for PACS PLUS 5TH EDITION?

The FDA 510(k) record lists Medical Standard Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PACS PLUS 5TH EDITION?

The FDA product code for PACS PLUS 5TH EDITION 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 Medical Standard Co., Ltd. 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.

K042311PACSPARTNERK023460PACSPLUS

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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