DRX-Transportable System - DRX-TRANSPORTABLE SYSTEM/LITE - CARESTREAM HEALTH, INC.

Duns Number:793169512

Device Description: DRX-TRANSPORTABLE SYSTEM/LITE

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More Product Details

Catalog Number

8619983

Brand Name

DRX-Transportable System

Version/Model Number

DRX-Transportable System

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K090318

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

a5601bce-d7e3-4d65-bfbb-f3ea24cfa0a4

Public Version Date

March 23, 2020

Public Version Number

1

DI Record Publish Date

March 13, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CARESTREAM HEALTH, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 328
2 A medical device with a moderate to high risk that requires special controls. 688