(88 days)
The Konica Laser Imager DRYPRO model 722 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.
Konica Laser Imager DRYPRO model 722 is a laser imager
This document is a 510(k) clearance letter from the FDA for a Konica Laser Imager DRYPRO model 722. It primarily focuses on regulatory approval and does not contain specific information regarding the acceptance criteria of a study that proves the device meets those criteria.
The letter states that the device is substantially equivalent to legally marketed predicate devices. This substantial equivalence is based on the device conforming to general controls provisions of the Act and current Good Manufacturing Practice requirements. However, it does not provide details of performance studies or acceptance criteria as would be found in a clinical study report or a detailed submission summary.
Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance because it is not present in the provided text.
§ 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.