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The Laser Film Digitizer 2905 is indicated for scanning medical radiographs with a laser beam and generating a digital electrical signal from the transmitted light.

The Laser Film Digitizer 2905 is an image scanner which reads black and white images from transmitted light through an X-ray film and the like, and transfers the images as the digital data to a computer. It has the following features:

• (1) Since the 2905 is equipped with a photomultiplier having wide dynamic range as a sensor, it can read high density films, such as a film whose optical density is up to 4.0.
• 2 The 2905 can output 4096 gray levels (12 bits) which are linear to optical density.
• 3. The 2905 can read a film at high speed using laser.
• 4 The interface of the 2905 is SCSI-2, so that it can transfer data at high speed.

The provided text describes a 510(k) premarket notification for a Laser Film Digitizer (Model 2905) and focuses on its substantial equivalence to predicate devices. It does not contain information about an acceptance criteria table, a specific study proving the device meets those criteria, sample sizes for test or training sets, data provenance, expert ground truth establishment, adjudication methods, multi-reader multi-case studies, or standalone algorithm performance.

The document primarily acts as an application to market the device, demonstrating its features and compliance with safety standards in comparison to existing, cleared devices.

Therefore, I cannot provide the requested information from the given text.

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