KONICA DIRECT DIGITIZER REGIUS MODEL 330

• K Number: K980873
• Device Name: KONICA DIRECT DIGITIZER REGIUS MODEL 330
• Manufacturer: KONICA CORP.
• Date Cleared: 1998-06-19 ( 105 days)
• Product Code: LMA
• Regulation Number: 892.2030
• Type: Traditional
• Panel: RA
• Reference & Predicate Devices: N/A

Intended Use

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

Device Description

Not Found

AI/ML Overview

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.

Regulation Number and Section

§ 892.2030 Medical image digitizer.

(a)
Identification. A medical image digitizer is a device intended to convert an analog medical image into a digital format. Examples include Iystems employing video frame grabbers, and scanners which use lasers or charge-coupled devices.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std.). 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.