FDA 510(k)

MasteRad MiniX Mobile Digital Imaging System (Mini-X)

Номер K: K242731 · 2025-05-16

Дата решения2025-05-16

Код продуктаOWB

Консультативный комитетRA

РешениеSubstantially Equivalent

Описание устройства

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.

Часто задаваемые вопросы

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.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: OWB)

K253726uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd.K261413EXTRON 3;EXTRON 6DRTECH Corporation K254205Zenition 30Philips Medical Systems Nederland B.V.K260607Shield System (Siemens 30x40)Radiaction , Ltd.K253670SmartCT (R3.0 (L10))Philips Medical Systems B.V.K252735C-beamPulmera, Inc.

Официальный источник

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