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FDA 510(k)

DENTAL DIGITAL X-RAY IMAGING SYSTEM

K-Number: K073365 · 2008-04-08

ApplicantVATECH Co., Ltd.
Decision Date2008-04-08
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTAL DIGITAL X-RAY IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is VATECH Co., Ltd.. It received FDA 510(k) clearance on 2008-04-08 under 510(k) number K073365. 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 DENTAL DIGITAL X-RAY IMAGING SYSTEM?

DENTAL DIGITAL X-RAY IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 2008-04-08. The listed applicant is VATECH Co., Ltd.. The 510(k) number is K073365.

When did DENTAL DIGITAL X-RAY IMAGING SYSTEM receive FDA 510(k) clearance?

DENTAL DIGITAL X-RAY IMAGING SYSTEM received FDA 510(k) clearance on 2008-04-08, under 510(k) number K073365.

Who is the listed applicant for DENTAL DIGITAL X-RAY IMAGING SYSTEM?

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

What is the FDA product code for DENTAL DIGITAL X-RAY IMAGING SYSTEM?

The FDA product code for DENTAL DIGITAL X-RAY IMAGING SYSTEM is MUH.

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Related Devices (Code: MUH)

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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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