FDA 510(k)

Green16/Green18 (Model: PHT-65LHS)

K-Number: K170066 · 2017-06-16

Decision Date2017-06-16

Product CodeOAS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Green16/Green18 (Model: PHT-65LHS) is a medical device manufactured by VATECH Co., Ltd.. It received FDA 510(k) clearance on 2017-06-16 under approval number K170066. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Green16/Green18 (Model: PHT-65LHS)?

Green16/Green18 (Model: PHT-65LHS) is a medical device that received FDA 510(k) clearance on 2017-06-16. It is manufactured by VATECH Co., Ltd.. The 510(k) number is K170066.

When was Green16/Green18 (Model: PHT-65LHS) approved by the FDA?

Green16/Green18 (Model: PHT-65LHS) received FDA 510(k) clearance on 2017-06-16, under approval number K170066.

What company makes Green16/Green18 (Model: PHT-65LHS)?

Green16/Green18 (Model: PHT-65LHS) is manufactured by VATECH Co., Ltd..

What is the FDA product code for Green16/Green18 (Model: PHT-65LHS)?

The FDA product code for Green16/Green18 (Model: PHT-65LHS) is OAS.

Other Devices by VATECH Co., Ltd.

K160882PaX-i3D Green Premium (Model: PCT-90LH) K162660Green Smart (Model: PHT-35LHS) K161063EzRay Air (Model VEX-P300) K170731System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i Insight K163705EzRay Air W K201627Dental Computed Tomography X-Ray System, Green X

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Related Devices (Code: OAS)

K161900HYPERION X5Cefla S.C. K160166X-MIND triumDe Gotzen S.R.L. K162085i-CAT FLX V series / KaVo 3D eXam+ V seriesImaging Sciences International K160882PaX-i3D Green Premium (Model: PCT-90LH)VATECH Co., Ltd. K162660Green Smart (Model: PHT-35LHS)VATECH Co., Ltd. K161881PreXion3D ExcelsiorPrexion Corporation

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.