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)

布拉斯勒爾 GEM，布拉斯勒爾 GEM10，布拉斯勒爾 GEM15，布拉斯勒爾 GEM20

K 號：K221955 · 2022-08-31

申請人Realcloud Imaging Inc. Dba Realcloud Imaging
決定日期2022-08-31
產品代碼MUH
諮詢委員會DE
決定相當於

器材摘要

Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20 is the device name listed in this FDA 510(k) record. The listed applicant is Realcloud Imaging Inc. Dba Realcloud Imaging. It received FDA 510(k) clearance on 2022-08-31 under 510(k) number K221955. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20?

Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20 is a medical device that received FDA 510(k) clearance on 2022-08-31. The listed applicant is Realcloud Imaging Inc. Dba Realcloud Imaging. The 510(k) number is K221955.

When did Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20 receive FDA 510(k) clearance?

Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20 received FDA 510(k) clearance on 2022-08-31, under 510(k) number K221955.

Who is the listed applicant for Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20?

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

What is the FDA product code for Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20?

The FDA product code for Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20 is MUH.

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

相關器械（代碼：MUH）

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。

K251793SOTA雲端智慧感測器（1.5）Sota Cloud Corp.K252570EzSensor HD，EzSensor UHDQpix Solutions, Inc.K250687Cocoon獨立 (DX-7020s)Dexcowin Global, Inc.K251206數位X光牙科DentiMax Pro影像系統Dentimax, Inc.K240040VistaPano S Ceph 2.0 (VistaPano S Ceph)；VistaPano S 2.0 (VistaPano S)；ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph)；ProVecta S-Pan 2.0 (ProVecta S-Pan)VATECH Co., Ltd.K242778X感測器（型號：IOS-A15IF，HDI-15DGF）Qpix Solutions, Inc.

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。

↑