(49 days)
the identification, capture, digitization and processing of diagnostic x-ray images from x-ray film and from phosphor imaging plates.
The Cobrascan CR-1 Filmless is a computed radiography dual technology scanner. It is an enhanced modification of the Cobrascan CX-312T (FDA #K953942) CCD x-ray film digitizer.
The provided text is a 510(k) premarket notification letter from the FDA regarding the Cobrascan CR-1 Filmless device, a computed radiography dual-technology scanner. It states that the device is substantially equivalent to a legally marketed predicate device.
However, the document DOES NOT contain information about specific acceptance criteria, study details (like sample sizes, ground truth establishment, expert qualifications, adjudication methods), or performance metrics (like sensitivity, specificity, or reader study results). The letter focuses on regulatory approval based on substantial equivalence rather than detailed clinical or technical performance studies.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and the study proving the device meets those criteria, as this information is not present in the provided text.
§ 892.2030 Medical image digitizer.
(a)
Identification. A medical image digitizer is a device intended to convert an analog medical image into a digital format. Examples include Iystems employing video frame grabbers, and scanners which use lasers or charge-coupled devices.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std.). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.