FDA 510(k)

牙科计算机断层扫描X射线系统，绿色X

K号: K201627 · 2020-10-27

决定日期2020-10-27

产品代码OAS

咨询委员会RA

决定实质等同

器械摘要

Dental Computed Tomography X-Ray System, Green X 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 2020-10-27 under 510(k) number K201627. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Dental Computed Tomography X-Ray System, Green X?

Dental Computed Tomography X-Ray System, Green X is a medical device that received FDA 510(k) clearance on 2020-10-27. The listed applicant is VATECH Co., Ltd.. The 510(k) number is K201627.

When did Dental Computed Tomography X-Ray System, Green X receive FDA 510(k) clearance?

Dental Computed Tomography X-Ray System, Green X received FDA 510(k) clearance on 2020-10-27, under 510(k) number K201627.

Who is the listed applicant for Dental Computed Tomography X-Ray System, Green X?

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 Computed Tomography X-Ray System, Green X?

The FDA product code for Dental Computed Tomography X-Ray System, Green X is OAS.

列明VATECH Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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（型号：PHT-75CHS）K223058EzRay Air 2 Wall (型号：VEX-S350W)

查看所有 18 个设备 →

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。