RAYMO移動X光系統（型號：RAYMO）
K 號：K260085 · 2026-05-14
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器材摘要
RAYMO Mobile X-ray System (Model: RAYMO) is the device name listed in this FDA 510(k) record. The listed applicant is DRGEM Corporation. It received FDA 510(k) clearance on 2026-05-14 under 510(k) number K260085. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the RAYMO Mobile X-ray System (Model: RAYMO)?
RAYMO Mobile X-ray System (Model: RAYMO) is a medical device that received FDA 510(k) clearance on 2026-05-14. The listed applicant is DRGEM Corporation. The 510(k) number is K260085.
When did RAYMO Mobile X-ray System (Model: RAYMO) receive FDA 510(k) clearance?
RAYMO Mobile X-ray System (Model: RAYMO) received FDA 510(k) clearance on 2026-05-14, under 510(k) number K260085.
Who is the listed applicant for RAYMO Mobile X-ray System (Model: RAYMO)?
The FDA 510(k) record lists DRGEM Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for RAYMO Mobile X-ray System (Model: RAYMO)?
The FDA product code for RAYMO Mobile X-ray System (Model: RAYMO) is IZL.
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其他以 DRGEM Corporation 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。
相關器械（代碼：IZL）
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
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。
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