Intended Use

The Radiography 7300 C is intended for use as a stationary X-ray system to acquire diagnostic radiographic images.

Technology

The system features advanced X-ray imaging technology with digital image capture and processing components to produce high-resolution radiographic images suitable for clinical analysis.

Performance

Performance testing included validation of image quality, system reliability, and compliance with medical device safety standards through bench testing and clinical evaluations.

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    11/15/2023

    7 months
  • 2

    FDA Approval

    6/13/2024

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