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Intended Use

uDR 380i Pro is a mobile digital radiography device intended to acquire X-ray images of the human anatomy for medical diagnosis. uDR 380i Pro can be used on both adult and pediatric patient by a qualified and trained operator. This device is not intended for mammography.

Technology

The uDR 380i Pro is a diagnostic mobile x-ray system utilizing digital radiography (DR) technology. It includes a lifting column with telescopic cantilever frame system, x-ray system comprising a high voltage generator, x-ray tube, collimator and wireless flat panel detectors previously cleared in K230175. It also includes a power supply system and software for acquiring and processing clinical images. The additions in this version are new flat panel detectors (CXDI-710C and CXDI-810C) and CXDI Control Software NE.

Performance

Non-clinical tests verified the device met all design specifications and conformed to relevant safety and performance standards including IEC and ISO for electrical safety, EMC, biocompatibility, radiation protection, usability, and software processes. Clinical image evaluation under the proposed device with CXDI-710C showed sufficient image quality for clinical diagnosis on a range of anatomical sites (head, chest, abdomen, spine, pelvis, extremities) as reviewed by a board-certified radiologist.

View FDA documentation

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    8/23/2024

    1 month
  • 2

    FDA Approval

    10/10/2024

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