FDA 510(k)

VivoSight Dx 皮膚用光學斷層掃描系統

K 號：K153283 · 2016-08-11

決定日期2016-08-11

產品代碼NQQ

諮詢委員會RA

決定相當於

器材摘要

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.

常見問題

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.

相關器械（代碼：NQQ）

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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：NQQ）

官方來源