FDA 510(k)

VivoSight Dx皮膚用OCTシステム

K番号: K153283 · 2016-08-11

決定日2016-08-11

製品コードNQQ

諮問委員会RA （注：由于原文中未提供具体的医疗设备监管文本内容，因此无法进行翻译。请提供具体的文本内容以便进行翻译。）

決定大幅同等

医療機器の概要

VivoSight Dx Topical OCT System is the device name listed in this FDA 510(k) record. The listed applicant is Michelson Diagnostics, Ltd.. It received FDA 510(k) clearance on 2016-08-11 under 510(k) number K153283. The device is classified under product code NQQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the VivoSight Dx Topical OCT System?

VivoSight Dx Topical OCT System is a medical device that received FDA 510(k) clearance on 2016-08-11. The listed applicant is Michelson Diagnostics, Ltd.. The 510(k) number is K153283.

When did VivoSight Dx Topical OCT System receive FDA 510(k) clearance?

VivoSight Dx Topical OCT System received FDA 510(k) clearance on 2016-08-11, under 510(k) number K153283.

Who is the listed applicant for VivoSight Dx Topical OCT System?

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

What is the FDA product code for VivoSight Dx Topical OCT System?

The FDA product code for VivoSight Dx Topical OCT System is NQQ.

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VivoSight Dx皮膚用OCTシステム

医療機器の概要

よくある質問

関連する臨床試験

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