AccessGUDID - DEVICE: Konica Minolta SW (PACS) Opal Rad, 20/20 Opal Rad (00817100020490)

GUDID

Device Identifier (DI) Information

Brand Name: Konica Minolta SW (PACS) Opal Rad, 20/20 Opal Rad
Version or Model: OPAL 02-04-06-000
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.

Primary DI Number: 00817100020490
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080269345 *Terms of Use

Device Description: Opal-RAD is a software device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations.

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):	Yes
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?
40935	Diagnostic x-ray digital imaging system workstation	A freestanding component of an x-ray-based diagnostic digital imaging assembly [e.g., a digital x-ray system, x-ray computed tomography (CT) system, or fluoroscopy system] designed to process patient radiological images; it may additionally be intended to be integrated as part of a radiology picture archiving and communication system (PACS). It consists of dedicated hardware (e.g., computer processing unit, monitor) with integrated software typically to assist image analysis (e.g., viewing, manipulation, interpretation); it does not include controls for direct operation of the imaging system.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KPR	System, X-Ray, Stationary

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: 0f13406f-ee5a-406f-9803-811d58aaa30f
Public Version Date: February 21, 2019
Public Version Number: 3
DI Record Publish Date: October 18, 2016