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FDA 510(k)

KODAK 9000C EXTRAORAL IMAGING SYSTEM

K-Number: K080889 · 2008-04-29

ApplicantTrophy
Decision Date2008-04-29
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

KODAK 9000C EXTRAORAL IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Trophy. It received FDA 510(k) clearance on 2008-04-29 under 510(k) number K080889. 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 KODAK 9000C EXTRAORAL IMAGING SYSTEM?

KODAK 9000C EXTRAORAL IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 2008-04-29. The listed applicant is Trophy. The 510(k) number is K080889.

When did KODAK 9000C EXTRAORAL IMAGING SYSTEM receive FDA 510(k) clearance?

KODAK 9000C EXTRAORAL IMAGING SYSTEM received FDA 510(k) clearance on 2008-04-29, under 510(k) number K080889.

Who is the listed applicant for KODAK 9000C EXTRAORAL IMAGING SYSTEM?

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 KODAK 9000C EXTRAORAL IMAGING SYSTEM?

The FDA product code for KODAK 9000C EXTRAORAL IMAGING SYSTEM is MUH.

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Other records listing Trophy as applicant

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K193390CS Model+K200183CS 9600K181136CS 9600K173622CS ImagingK120975CS 8100 CS 8100 ACCESSK113419CS IMAGING

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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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