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FDA 510(k)

CS IMAGING

K-Number: K113419 · 2012-02-16

ApplicantTrophy
Decision Date2012-02-16
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CS IMAGING is the device name listed in this FDA 510(k) record. The listed applicant is Trophy. It received FDA 510(k) clearance on 2012-02-16 under 510(k) number K113419. 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 CS IMAGING?

CS IMAGING is a medical device that received FDA 510(k) clearance on 2012-02-16. The listed applicant is Trophy. The 510(k) number is K113419.

When did CS IMAGING receive FDA 510(k) clearance?

CS IMAGING received FDA 510(k) clearance on 2012-02-16, under 510(k) number K113419.

Who is the listed applicant for CS IMAGING?

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

What is the FDA product code for CS IMAGING?

The FDA product code for CS IMAGING is LLZ.

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Other records listing Trophy 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.

K193390CS Model+K200183CS 9600K181136CS 9600K173622CS ImagingK120975CS 8100 CS 8100 ACCESSK103659CS 9300, CS 9300C

View all 11 devices →

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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