免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料，僅供一般參考，不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

X100/X100HT 內建全場域周邊血液涂片（PBS）應用

K 號：K243144 · 2025-06-27

申請人Scopio Labs , Ltd.
決定日期2025-06-27
產品代碼JOY
諮詢委員會HE 請提供完整的描述文本，以便我能夠進行翻譯。
決定相當於

器材摘要

X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application is the device name listed in this FDA 510(k) record. The listed applicant is Scopio Labs , Ltd.. It received FDA 510(k) clearance on 2025-06-27 under 510(k) number K243144. The device is classified under product code JOY. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application?

X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application is a medical device that received FDA 510(k) clearance on 2025-06-27. The listed applicant is Scopio Labs , Ltd.. The 510(k) number is K243144.

When did X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application receive FDA 510(k) clearance?

X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application received FDA 510(k) clearance on 2025-06-27, under 510(k) number K243144.

Who is the listed applicant for X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application?

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

What is the FDA product code for X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application?

The FDA product code for X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application is JOY.

相關臨床試驗

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。

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

其他以 Scopio Labs , Ltd. 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。

K220013X100HT 配備滑動加載器，全場周邊血液涂片（PBS）應用K201301X100 配合全場周邊血液涂片（PBS）應用

相關器械（代碼：JOY）

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。

K221309AI100 with ShonitSigtuple Technologies Pvt. , Ltd.K220013X100HT 配備滑動加載器，全場周邊血液涂片（PBS）應用Scopio Labs , Ltd.K200595CellaVision DC-1, CellaVision DC-1 PPACellaVision ABK201301X100 配合全場周邊血液涂片（PBS）應用Scopio Labs , Ltd.K182062Sysmex UD-10，全自動尿沉渣數位影像設備Sysmex America, Inc.K171315先進紅血球應用CellaVision AB

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。

↑