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FDA 510(k)

MasteRad MiniX 行動數位影像系統(Mini-X)

K 號:K242731 · 2025-05-16

決定日期2025-05-16
產品代碼OWB
諮詢委員會RA
決定相當於

器材摘要

MasteRad MiniX Mobile Digital Imaging System (Mini-X) is the device name listed in this FDA 510(k) record. The listed applicant is Medicatech USA, Inc.. It received FDA 510(k) clearance on 2025-05-16 under 510(k) number K242731. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MasteRad MiniX Mobile Digital Imaging System (Mini-X)?

MasteRad MiniX Mobile Digital Imaging System (Mini-X) is a medical device that received FDA 510(k) clearance on 2025-05-16. The listed applicant is Medicatech USA, Inc.. The 510(k) number is K242731.

When did MasteRad MiniX Mobile Digital Imaging System (Mini-X) receive FDA 510(k) clearance?

MasteRad MiniX Mobile Digital Imaging System (Mini-X) received FDA 510(k) clearance on 2025-05-16, under 510(k) number K242731.

Who is the listed applicant for MasteRad MiniX Mobile Digital Imaging System (Mini-X)?

The FDA 510(k) record lists Medicatech USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MasteRad MiniX Mobile Digital Imaging System (Mini-X)?

The FDA product code for MasteRad MiniX Mobile Digital Imaging System (Mini-X) is OWB.

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相關器械(代碼:OWB)

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。

官方來源

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