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FDA 510(k)

PaX-i3D Green Premium (Model: PCT-90LH)

K-Number: K160882 · 2016-10-28

ApplicantVATECH Co., Ltd.
Decision Date2016-10-28
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PaX-i3D Green Premium (Model: PCT-90LH) 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 2016-10-28 under 510(k) number K160882. 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 PaX-i3D Green Premium (Model: PCT-90LH)?

PaX-i3D Green Premium (Model: PCT-90LH) is a medical device that received FDA 510(k) clearance on 2016-10-28. The listed applicant is VATECH Co., Ltd.. The 510(k) number is K160882.

When did PaX-i3D Green Premium (Model: PCT-90LH) receive FDA 510(k) clearance?

PaX-i3D Green Premium (Model: PCT-90LH) received FDA 510(k) clearance on 2016-10-28, under 510(k) number K160882.

Who is the listed applicant for PaX-i3D Green Premium (Model: PCT-90LH)?

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 PaX-i3D Green Premium (Model: PCT-90LH)?

The FDA product code for PaX-i3D Green Premium (Model: PCT-90LH) is OAS.

Other records listing VATECH Co., Ltd. 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.

K260093Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)K243088Green X 12 SE (PHT-40CHS)K243081Green X 21 (PHT-90CHO)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)K231796Grreen X 12 (Model: PHT-75CHS)K223058EzRay Air 2 Wall (Model: VEX-S350W)

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Related Devices (Code: OAS)

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.

K261748Dental Cone-beam Computed Tomography (mDX-15P Series)Hefei Meyer Optoelectronic Technology, Inc.K250839Dental X-ray SystemChangzhou Boen Zhongding Medical Technology Co., Ltd.K260662Dental Cone Beam Computed Tomography SystemYofo Medical Technology Co., Ltd.K253935medXion NEXUSmedXion Technologies, Inc.K260462RCT800Ray Co., Ltd.K260093Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)VATECH Co., Ltd.

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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