(83 days)
The diseases and conditions that the device will aid in the diagnosis of, are those that are typical to radiological types of examinations.
The LR 5200 is a laser based (Helium-neon) film recorder, designed for producing high quality gray scale diagnostic medical images, when interfaced to a host imaging device. Typical host imaging devices would include those of Magnetic Resonance, Computed Tomography, Ultrasound, Mammography, Digital Radiography, and Nuclear Medicine imaging modalities.
There is insufficient information in the provided text to describe acceptance criteria and associated study details. The document is a 510(k) summary for a "Laser Film Recorder" and focuses on device description, technological characteristics, and substantial equivalence to other devices. It does not contain any details about acceptance criteria for performance metrics, clinical studies, or AI/algorithm 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.