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

GUDID 00817100020209

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 Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation

• Primary Device ID: 00817100020209
• NIH Device Record Key: aa8e80b6-c2d5-458c-b7f4-f304bc10f179
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Konica Minolta SW (PACS) Opal Rad, 20/20 Opal Rad
• Version Model Number: OPAL 02-04-04-000
• Company DUNS: 080269345
• Company Name: KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-366-5343
• Email: HTICSupport@konicaminolta.com
• Phone: 1-800-366-5343
• Email: HTICSupport@konicaminolta.com
• Phone: 1-800-366-5343
• Email: HTICSupport@konicaminolta.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817100020209 [Primary]

FDA Product Code

• KPR: System, X-Ray, Stationary

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-02-21
• Device Publish Date: 2016-09-24

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

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