Device typeTissue specimen x-ray system IVD: An assembly of devices designed to produce an x-ray image of a tissue sample (e.g., stereotactic biopsy cores taken during mammographic procedures) and/or an amputated body part, by generating and controlling x-ray beams and recording the absorption patterns of the x-rays. The system typically includes a cabinet where the specimen is placed and a screen; the image is generated via digital imaging methods.
FDA categoryCabinet, x-ray system
Device ID25420045516622
Catalog number04-4126
AvailabilityPrescription
Single useYes
MRI safetyLabeling does not contain MRI Safety Information