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FDA 510(k)

APAX PACS SYSTEM

K-Number: K032760 · 2003-09-17

ApplicantTis, Inc.
Decision Date2003-09-17
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

APAX PACS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Tis, Inc.. It received FDA 510(k) clearance on 2003-09-17 under 510(k) number K032760. 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 APAX PACS SYSTEM?

APAX PACS SYSTEM is a medical device that received FDA 510(k) clearance on 2003-09-17. The listed applicant is Tis, Inc.. The 510(k) number is K032760.

When did APAX PACS SYSTEM receive FDA 510(k) clearance?

APAX PACS SYSTEM received FDA 510(k) clearance on 2003-09-17, under 510(k) number K032760.

Who is the listed applicant for APAX PACS SYSTEM?

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

What is the FDA product code for APAX PACS SYSTEM?

The FDA product code for APAX PACS SYSTEM 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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