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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 a medical device manufactured by Medicatech USA, Inc.. It received FDA 510(k) clearance on 2025-05-16 under approval 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. It is manufactured by Medicatech USA, Inc.. The 510(k) number is K242731.

When was MasteRad MiniX Mobile Digital Imaging System (Mini-X) approved by the FDA?

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

What company makes MasteRad MiniX Mobile Digital Imaging System (Mini-X)?

MasteRad MiniX Mobile Digital Imaging System (Mini-X) is manufactured by Medicatech USA, Inc..

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.

Related Clinical Trials

NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT07301385 Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety and Workflow Study ACTIVE_NOT_RECRUITING NCT03331380 Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System RECRUITING NCT04981223 Predicting Location and Extent of Prostate Cancer Using Micro-Ultrasound Imaging COMPLETED NCT06385392 Continuous Wearable Monitor for the Detection and Release of Freezing of Gait. COMPLETED NCT07608614 Sleep and Performance RECRUITING

Related PubMed Literature

PMID: 42204020 A Minimal UDI-DICOM Mapping Profile and Validation Artifact for Medical-Device Imaging Workflows. Journal of imaging informatics in medicine (2026) PMID: 41476571 Digital pathology imaging artificial intelligence in cancer research and clinical trials: An NCI workshop report. Journal of pathology informatics (2026) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 40271230 When Software Becomes Medicine: Ignoring It May Soon Be Malpractice. Cureus (2025)

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Official Source

View on FDA Database →

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