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FDA 510(k)

CS 8100 CS 8100 ACCESS

K-Number: K120975 · 2012-06-22

ApplicantTrophy
Decision Date2012-06-22
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CS 8100 CS 8100 ACCESS is the device name listed in this FDA 510(k) record. The listed applicant is Trophy. It received FDA 510(k) clearance on 2012-06-22 under 510(k) number K120975. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CS 8100 CS 8100 ACCESS?

CS 8100 CS 8100 ACCESS is a medical device that received FDA 510(k) clearance on 2012-06-22. The listed applicant is Trophy. The 510(k) number is K120975.

When did CS 8100 CS 8100 ACCESS receive FDA 510(k) clearance?

CS 8100 CS 8100 ACCESS received FDA 510(k) clearance on 2012-06-22, under 510(k) number K120975.

Who is the listed applicant for CS 8100 CS 8100 ACCESS?

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 8100 CS 8100 ACCESS?

The FDA product code for CS 8100 CS 8100 ACCESS is MUH.

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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 ImagingK113419CS IMAGINGK103659CS 9300, CS 9300C

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Related Devices (Code: MUH)

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.

K251793SOTA Cloud Smart Sensor (1.5)Sota Cloud Corp.K252570EzSensor HD, EzSensor UHDQpix Solutions, Inc.K250687Cocoon Solo (DX-7020s)Dexcowin Global, Inc.K251206Digital X-Ray DentiMax Pro Imaging SystemDentimax, Inc.K240040VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan)VATECH Co., Ltd.K242778X Sensor (Model: IOS-A15IF, HDI-15DGF)Qpix Solutions, Inc.

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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