PowerDR
Radiology Information Systems, Inc.
RADIOLOGY INFORMATION SYSTEMS, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1125622 | 3002952981 | RADIOLOGY INFORMATION SYSTEMS, INC. | 1 | N | 2026-01-01 | 43676 TRADE CENTER PLACE SUITE 100 DULLES VA US 20166 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 53165 | 1522763642 | K191504 | PowerDR | JAA | 2019-08-16 |
| 53165 | 1664132232 | K102849 | ACCULMAING | LLZ | 2010-11-23 |
| 53165 | 1881950130 |
Product Codes Associated With Registrations#
PMN#
ACCULMAING
RADIOLOGY INFORMATION SYSTEMS, INC.
RIS SCANVIEW SYSTEM (RSVS)
RADIOLOGY INFORMATION SYSTEMS, INC.
GUDID#
Radiology Information Systems, Inc. - For use as a storage and display node on a DICOM 3.0 Network. It can receive, store, transmit and display images as a PACS application. In addition it can merge information from its keyboard with bitmap images from imaging devices to create DICOM 3.0 image files
2022-12-01
Radiology Information Systems, Inc. - Software module capable of taking an x-ray image generated by a CR or DR and producing a digitally enhanced image for projecting radiographic and/or fluoroscopic applications. AccuImaging is not indicated for use in mammography.
2022-12-01
Radiology Information Systems, Inc. - 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).
2022-12-01