(85 days)
The LR5200 Laser Film Recorder is indicated for use in providing diagnostic quality medical images on film for aid in physician diagnosis, including the printing of images from various digital imaging source modalities, including, but not limited to, Computed Tomography (CT), Magnetic Resonance Imaging (MRI), Ultrasound, Computed Radiography, Digital Mammography, and Nuclear Medicine.
No changes in hardware or software are being implemented to the currently marketed LR5200. The present 510(k) is only for a clarification in the indications for use. The LR5200 is a laser (He-Ne) film recorder designed to produce high quality gray scale diagnostic medical images when interfacted to a host imaging device or PACS system. The LR5200 uses a wet process for developing the medical images.
The provided text is a 510(k) summary for the Agfa LR 5200 Laser Film Recorder. Upon review, it's clear that this submission is not for a new device requiring performance testing against acceptance criteria. Instead, it's a clarification of the indications for use for an already legally marketed device (K964414).
Therefore, no acceptance criteria or study data demonstrating device performance are provided in this document. The key statements confirming this are:
- "No changes in hardware or software are being implemented to the currently marketed LR5200."
- "The present 510(k) is only for a clarification in the indications for use."
- "No additional testing was carried out for this premarket notification since the device is already indicated for the same uses."
- "The LR 5200 Laser Film Recorder has the same (identical) technological characteristics as the predicate device."
Because this submission is an amendment regarding indications for use and explicitly states "No additional testing was carried out," the request for details on acceptance criteria, device performance, sample sizes, experts, adjudication, MRMC studies, standalone performance, and ground truth for testing and training cannot be fulfilled from this 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.