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FDA 510(k)

MasteRad MiniX 移动数字成像系统(Mini-X)

K号: K242731 · 2025-05-16

决定日期2025-05-16
产品代码OWB
咨询委员会RA
决定实质等同

器械摘要

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.

常见问题

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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相关器械(代码:OWB)

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系;请查阅链接的官方来源。

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