FDA 510(k)

OTIS光學相幹斷層掃描系統

K 號：K190404 · 2019-03-26

決定日期2019-03-26

產品代碼NQQ

諮詢委員會RA

決定相當於

器材摘要

OTIS Optical Coherence Tomography SYstem is the device name listed in this FDA 510(k) record. The listed applicant is Perimeter Medical Imaging, Inc.. It received FDA 510(k) clearance on 2019-03-26 under 510(k) number K190404. 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 OTIS Optical Coherence Tomography SYstem?

OTIS Optical Coherence Tomography SYstem is a medical device that received FDA 510(k) clearance on 2019-03-26. The listed applicant is Perimeter Medical Imaging, Inc.. The 510(k) number is K190404.

When did OTIS Optical Coherence Tomography SYstem receive FDA 510(k) clearance?

OTIS Optical Coherence Tomography SYstem received FDA 510(k) clearance on 2019-03-26, under 510(k) number K190404.

Who is the listed applicant for OTIS Optical Coherence Tomography SYstem?

The FDA 510(k) record lists Perimeter Medical Imaging, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OTIS Optical Coherence Tomography SYstem?

The FDA product code for OTIS Optical Coherence Tomography SYstem is NQQ.

其他以 Perimeter Medical Imaging, Inc. 為申請人之記錄

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K171560OTIS光斷層掃描系統 K160240Perimeter Otis™ 1.0 光學相幹斷層系統

相關器械（代碼：NQQ）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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