AccessGUDID - DEVICE: Q-Rad System (60889971031105)

GUDID

Device Identifier (DI) Information

Brand Name: Q-Rad System
Version or Model: Q-Rad System
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1031103
Company Name: CARESTREAM HEALTH, INC.

Primary DI Number: 60889971031105
Issuing Agency: GS1
Commercial Distribution End Date: January 24, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 793169512 *Terms of Use

Device Description: Q-RAD SYSTEM CH/QG-4000-4-R10-T080

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
37644	Stationary basic diagnostic x-ray system, analogue	An assembly of devices that comprise a general-purpose stationary diagnostic x-ray system used in a variety of routine planar x-ray imaging applications. It is typically an x-ray film based system that use analogue or analogue-to-digital techniques for image capture and display. The stationary design requires it to be installed and used in a fixed location within a building or in a transportation van (mobile imaging facility). This system consists of modular configurations that can be upgraded by the addition of hardware/software components or accessories. This GMDN code does not cover systems with fluoroscopic or tomographic capabilities.	Active	false
37645	Stationary basic diagnostic x-ray system, digital	An assembly of devices that comprise general-purpose stationary diagnostic x-ray system used in a variety of routine planar x-ray imaging applications. It uses digital techniques for image capture, display and manipulation. The stationary design requires it to be installed and used in a fixed location within a building or in a transportation van (a mobile imaging van). This system consists of modular configurations that can be upgraded by the addition of hardware/software components. This GMDN code does not cover systems with fluoroscopic or tomographic capabilities.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KPR	System, x-ray, stationary

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K151924	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: dbaa4781-8340-4fc8-80f2-b496e390335c
Public Version Date: January 16, 2019
Public Version Number: 4
DI Record Publish Date: September 23, 2016