ScanX Fit (with battery) - The ScanX D5000 series scanner is a device that - AIR TECHNIQUES, INC.

Duns Number:043835081

Device Description: The ScanX D5000 series scanner is a device that reads photostimulable phosphor plates that The ScanX D5000 series scanner is a device that reads photostimulable phosphor plates that have been exposed in place of x-ray film and allows those images to be displayed on a personal computer display.

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More Product Details

Catalog Number

-

Brand Name

ScanX Fit (with battery)

Version/Model Number

D5000FB

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K101289,K101289

Product Code Details

Product Code

MQB

Product Code Name

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

Device Record Status

Public Device Record Key

0645a708-a552-4d90-bc6a-8eb3681ca410

Public Version Date

August 23, 2018

Public Version Number

4

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

D678D5000FB1

Quantity per Package

1

Contains DI Package

D678D5000FB0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box

"AIR TECHNIQUES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 7
2 A medical device with a moderate to high risk that requires special controls. 11