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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.

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The Konica Direct Digitizer (Computed Radiography Device) Model DD-341/Regius 150 is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in general-purpose diagnostic procedures.

Konica Direct Digitizer, Model DD-341/Regius 150 is a Computed Radiography Device.

This document is a 510(k) clearance letter for the Konica Direct Digitizer, Model DD-341/Regius 150. It does not contain information about acceptance criteria or a study proving that the device meets those criteria. The letter acknowledges the company's intent to market the device and states that the FDA has determined it is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot fulfill the request for information regarding acceptance criteria and studies from the provided text.

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Reading, processing, displaying and printing X-ray images from exposed photostimulable phosphor plates.

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The provided text is a 510(k) clearance letter from the FDA for the Konica Direct Digitizer Regius Model 330. It does not contain any information about acceptance criteria or a study proving device performance.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input. The document is strictly a regulatory approval notice, indicating that the device has been deemed substantially equivalent to a predicate device.

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