FDA 510(k)

全視野AI生命徵象（1.6.1-22）

K 號：K260066 · 2026-05-21

決定日期2026-05-21

產品代碼QME

諮詢委員會履歷

決定相當於

器材摘要

PanopticAI Vital Signs (1.6.1-22) is the device name listed in this FDA 510(k) record. The listed applicant is PanopticAI Technologies Limited. It received FDA 510(k) clearance on 2026-05-21 under 510(k) number K260066. The device is classified under product code QME. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PanopticAI Vital Signs (1.6.1-22)?

PanopticAI Vital Signs (1.6.1-22) is a medical device that received FDA 510(k) clearance on 2026-05-21. The listed applicant is PanopticAI Technologies Limited. The 510(k) number is K260066.

When did PanopticAI Vital Signs (1.6.1-22) receive FDA 510(k) clearance?

PanopticAI Vital Signs (1.6.1-22) received FDA 510(k) clearance on 2026-05-21, under 510(k) number K260066.

Who is the listed applicant for PanopticAI Vital Signs (1.6.1-22)?

The FDA 510(k) record lists PanopticAI Technologies Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PanopticAI Vital Signs (1.6.1-22)?

The FDA product code for PanopticAI Vital Signs (1.6.1-22) is QME.

其他以 PanopticAI Technologies Limited 為申請人之記錄

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。

K240890全視野AI生命徵象

相關器械（代碼：QME）

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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官方來源

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