SMS 14X17 Flat Panel Detector-R


Product Overview

SMS 14X17 Flat Panel Detector
14X17 Flat Panel Detector - PAN251


Device Description

An assembly of medical devices designed to convert an existing analogue x-ray system to digital (i.e., retrofit) through the acquisition and processing of digital images using existing analogue x-ray system components. As a system it consists of both: 1) a filmless cassette-size digital detector (e.g., indirect flat panel detector); and 2) additional processing/viewing hardware [e.g., a central processing unit (CPU) with integrated software and a monitor]. Following acquisition the system is intended to also process, view, and/or store patient images as part of picture archiving and communication. It does not contain the controls for the direct operation of an x-ray imaging system.


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: 00817100020322

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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