(373 days)
Accessory to a cassette to convert X-Ray energy into light energy.
Not Found
The provided text is a 510(k) clearance letter from the FDA for "Konica Intensifying Screens MD100 and MM150." This type of document declares substantial equivalence to a predicate device and does not contain information about acceptance criteria or specific study details as would be found in a clinical study report or a premarket approval (PMA) application.
Therefore, I cannot extract the requested information regarding acceptance criteria and study details from the provided text. The document is a regulatory approval, not a scientific study report.
§ 892.1960 Radiographic intensifying screen.
(a)
Identification. A radiographic intensifying screen is a device that is a thin radiolucent sheet coated with a luminescent material that transforms incident x-ray photons into visible light and intended for medical purposes to expose radiographic film.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.