(26 days)
The Konica Laser Imager DRYPRO model 771 is a laser imager converts data from diagnostic equipment such as CT, MRI, DSA, and other medical devices into various intensities, scan and then print the data onto laser imaging film.
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The provided text is a 510(k) clearance letter from the FDA for a medical image hardcopy device, the "Konica Laser Imager DRYPRO model 771." It does not contain any information regarding acceptance criteria or a study proving the device meets those criteria.
The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed subject to general controls. It details regulatory information and contact points but does not describe any performance studies, data provenance, ground truth establishment, or expert involvement.
Therefore, I cannot fulfill your request for the specific information about acceptance criteria and a detailed study as this information is not present in the provided document.
§ 892.2040 Medical image hardcopy device.
(a)
Identification. A medical image hardcopy device is a device that produces a visible printed record of a medical image and associated identification information. Examples include multiformat cameras and laser printers.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern). 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.