Konica Minolta SW (PACS) Opal Rad, 20/20 Opal Rad

GUDID 00817100020490

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.

KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.

Diagnostic x-ray digital imaging system workstation
Primary Device ID00817100020490
NIH Device Record Key0f13406f-ee5a-406f-9803-811d58aaa30f
Commercial Distribution StatusIn Commercial Distribution
Brand NameKonica Minolta SW (PACS) Opal Rad, 20/20 Opal Rad
Version Model NumberOPAL 02-04-06-000
Company DUNS080269345
Company NameKONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-366-5343
EmailHTICSupport@konicaminolta.com
Phone1-800-366-5343
EmailHTICSupport@konicaminolta.com
Phone1-800-366-5343
EmailHTICSupport@konicaminolta.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100817100020490 [Primary]

FDA Product Code

KPRSystem, X-Ray, Stationary

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-02-21
Device Publish Date2016-10-18

On-Brand Devices [Konica Minolta SW (PACS) Opal Rad, 20/20 Opal Rad]

00817100020490Opal-RAD is a software device that receives digital images and data from various sources (i.e. C
00817100020209Opal-RAD is a software device that receives digital images and data from various sources (i.e. C

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