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FDA 510(k)

AMICAS VISION SERIES PACS, MODEL 5.5

K-Number: K073526 · 2008-03-12

ApplicantAmicas, Inc.
Decision Date2008-03-12
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AMICAS VISION SERIES PACS, MODEL 5.5 is the device name listed in this FDA 510(k) record. The listed applicant is Amicas, Inc.. It received FDA 510(k) clearance on 2008-03-12 under 510(k) number K073526. 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 AMICAS VISION SERIES PACS, MODEL 5.5?

AMICAS VISION SERIES PACS, MODEL 5.5 is a medical device that received FDA 510(k) clearance on 2008-03-12. The listed applicant is Amicas, Inc.. The 510(k) number is K073526.

When did AMICAS VISION SERIES PACS, MODEL 5.5 receive FDA 510(k) clearance?

AMICAS VISION SERIES PACS, MODEL 5.5 received FDA 510(k) clearance on 2008-03-12, under 510(k) number K073526.

Who is the listed applicant for AMICAS VISION SERIES PACS, MODEL 5.5?

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

What is the FDA product code for AMICAS VISION SERIES PACS, MODEL 5.5?

The FDA product code for AMICAS VISION SERIES PACS, MODEL 5.5 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 Amicas, Inc. 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.

K082144AMICAS PACS, VERSION 6.0K062477AMICAS VISION SERIES PACS, MODEL 4.3K022970AMICAS LIGHT BEAM WORKSTATION, MODEL 1.0

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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