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Radiology Information Systems, Inc.

FDA UDI

Class II (US FDA UDI)

by Radiology Information Systems, Inc.

Identity

Trade Name
Radiology Information Systems, Inc. FDA UDI
Generic Name
Radiology information system application software FDA UDI
Device Name
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). FDA UDI
Model / Reference
PowerDR FDA UDI
Description
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). FDA UDI

Identifiers

Primary DI / UDI-DI
00860009490604 FDA UDI
510(k) Number
K191504 FDA UDI
FDA Product Code
JAA FDA UDI
MQB FDA UDI
GMDN Term
Radiology information system application software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1650 FDA UDI
892.1680 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

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Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Radiology picture archiving and communication system workstationRadiology information system application softwareDiagnostic x-ray digital imaging system workstation

Radiology Information Systems, Inc. by Radiology Information Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Diagnostic x-ray digital imaging system workstation.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Radiology Information Systems, Inc.

Sources (1)

  • FDA UDI 2385a0e7-a26b-4d28-bd2b-d94ea2d65e1f 34 fields · synced Jun 6, 2026