Product Overview

CR Reader
CR Reader - CRII60


Device Description

A combination device for medical imaging applications that consists of a cassette used to hold and shield an attached storage phosphor screen from exposure to room light during transport and insertion into a diagnostic imaging x-ray system, and a computed radiography scanner. The photostimulatable storage phosphor screen is exposed to radiation by the x-ray system to record a patient radiation pattern. The cassette is then loaded into a laser scanner capable of reading the latent image formed on the storage phosphor screen to produce a digital image.


Environmental Conditions

No Data Available


Device Sizes

No Data Available


Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available


Product Codes

Code: MQB

Device Name: Solid State X-Ray Imager (Flat Panel/Digital Imager)

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: RA

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 892.1680

Third Party Flag: Y

Medical Specialty: RA


Device Identifiers

Device Id: 00817100020391

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A


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