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FDA 510(k)

UBIPACS

K-Number: K042507 · 2004-09-27

ApplicantIcm Co., Ltd.
Decision Date2004-09-27
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

UBIPACS is the device name listed in this FDA 510(k) record. The listed applicant is Icm Co., Ltd.. It received FDA 510(k) clearance on 2004-09-27 under 510(k) number K042507. 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 UBIPACS?

UBIPACS is a medical device that received FDA 510(k) clearance on 2004-09-27. The listed applicant is Icm Co., Ltd.. The 510(k) number is K042507.

When did UBIPACS receive FDA 510(k) clearance?

UBIPACS received FDA 510(k) clearance on 2004-09-27, under 510(k) number K042507.

Who is the listed applicant for UBIPACS?

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

What is the FDA product code for UBIPACS?

The FDA product code for UBIPACS 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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