Radiology Information Systems, Inc.

GUDID 00860009490604

PowerDR Console Application is an X-ray digital imaging system designed for generating high-resolution, full-fidelity digital projection radiographic and fluoroscopic images with an X-ray imaging receptor. The PowerDR Console Application receives imaging exam orders, acquires images from X-Ray detectors or from any DICOM device to process the images to produce real time fluoroscopic image sequences and full fidelity radiographic images for medical diagnostic purposes. The processed and/or received images can be stored in a local or web/cloud based Picture Archive and Communication System (PACS).

Radiology Information Systems, Inc.

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• Primary Device ID: 00860009490604
• NIH Device Record Key: 2385a0e7-a26b-4d28-bd2b-d94ea2d65e1f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Radiology Information Systems, Inc.
• Version Model Number: PowerDR
• Company DUNS: 107343670
• Company Name: Radiology Information Systems, 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: false
• Serial Number: true
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860009490604 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191504

FDA Product Code

• JAA: System, X-Ray, Fluoroscopic, Image-Intensified

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-09
• Device Publish Date: 2022-12-01

On-Brand Devices [Radiology Information Systems, Inc.]

• 00860009490642: For use as a storage and display node on a DICOM 3.0 Network. It can receive, store, transmit a
• 00860009490628: Software module capable of taking an x-ray image generated by a CR or DR and producing a digital
• 00860009490604: PowerDR Console Application is an X-ray digital imaging system designed for generating high-reso