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FDA 510(k)

ZIOSTATION

K-Number: K070205 · 2007-03-23

ApplicantZiosoft, Inc.
Decision Date2007-03-23
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ZIOSTATION is the device name listed in this FDA 510(k) record. The listed applicant is Ziosoft, Inc.. It received FDA 510(k) clearance on 2007-03-23 under 510(k) number K070205. 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 ZIOSTATION?

ZIOSTATION is a medical device that received FDA 510(k) clearance on 2007-03-23. The listed applicant is Ziosoft, Inc.. The 510(k) number is K070205.

When did ZIOSTATION receive FDA 510(k) clearance?

ZIOSTATION received FDA 510(k) clearance on 2007-03-23, under 510(k) number K070205.

Who is the listed applicant for ZIOSTATION?

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

What is the FDA product code for ZIOSTATION?

The FDA product code for ZIOSTATION 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 Ziosoft, 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.

K200315Ziostation2K181892Ziostation2K091262MR CARDIAC FUNCTION ANALYSISK083446CARDIAC FUNCTION ANALYSIS, CALCIUM SCORINGK083084CT BRAIN PERFUSION FOR ZIOSTATION

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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