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FDA 510(k)

OTIS 2.1 光學相幹斷層掃描系統，THiA 光學相幹斷層掃描系統

K 號：K203578 · 2021-02-25

申請人Perimeter Medical Imaging Ai, Inc.
決定日期2021-02-25
產品代碼NQQ
諮詢委員會RA
決定相當於

器材摘要

OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System is the device name listed in this FDA 510(k) record. The listed applicant is Perimeter Medical Imaging Ai, Inc.. It received FDA 510(k) clearance on 2021-02-25 under 510(k) number K203578. 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 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System?

OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System is a medical device that received FDA 510(k) clearance on 2021-02-25. The listed applicant is Perimeter Medical Imaging Ai, Inc.. The 510(k) number is K203578.

When did OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System receive FDA 510(k) clearance?

OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System received FDA 510(k) clearance on 2021-02-25, under 510(k) number K203578.

Who is the listed applicant for OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System?

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

What is the FDA product code for OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System?

The FDA product code for OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System is NQQ.

相關臨床試驗

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NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

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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