(127 days)
The Konica Laser Imager DRYPRO model 751/752 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 751/752 are laser imagers convert 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. This device consists of film supplying unit, film transferring unit, exposing unit, power supplying unit, heat-developing unit, operating unit, power supplying unit and control unit. This device is certified as a Class I laser product under 21CFR Chapter I, Subchapter J.
The provided text is a 510(k) summary for the Konica Laser Imager DRYPRO model 751/752. This document describes a medical imaging hardcopy device that converts digital image data into physical film. It does not describe an AI medical device that generates performance metrics like accuracy, sensitivity, or specificity against ground truth. Therefore, the requested information regarding acceptance criteria, study data, sample sizes, expert qualifications, and ground truth establishment is not applicable to this document.
The document primarily focuses on:
- Identification of the company and device.
- Classification of the device (Class II per 21 CFR 892.2040).
- Description of the device's function: converting digital data from diagnostic equipment (CT, MRI, DSA) into various intensities, scanning, and printing onto laser imaging film.
- Intended Use: detailed in the device description.
- Substantial Equivalence: claiming equivalence to a predicate device (Konica Laser Imager DRYPRO model 722, K992586).
- Compliance with standards: IEC60601-1-1, IEC60601-1-2, FCC, DHHS, UL, C-UL, C-TICK.
The only "performance" aspect mentioned refers to "clinical performance" characteristics in the context of substantial equivalence to the predicate device, but no specific performance metrics or studies are detailed in the provided text. The statement "The output of the device is evaluated by additional trained personnel allowing only. sufficient review to afford identification and intervention in case of malfunction" indicates human oversight, but not a study to prove meeting acceptance criteria in the sense of AI device performance.
§ 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.