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FDA 510(k)

MasteRad MiniX Mobile Digital Imaging System (Mini-X)

K-Number: K242731 · 2025-05-16

ApplicantMedicatech USA, Inc.
Decision Date2025-05-16
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing Medicatech USA, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K230918MasterX 800 SeriesK190601MasteRad MX30

Related Devices (Code: OWB)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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