Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1125622

FEI Number

3002952981

Entity Name

RADIOLOGY INFORMATION SYSTEMS, INC.

City/State/Country

DULLES, VA, US

Establishment Address

43676 TRADE CENTER PLACE, SUITE 100, DULLES, VA 20166, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

RADIOLOGY INFORMATION SYSTEMS, INC. (Owner Number: 9029503)

Owner / Operator Contact Address

43676 TRADE CENTER PLACE, SUITE 100, Dulles, VA 20166, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K191504

PMA Number

N/A

All Registered Proprietary Names

RSVS AccuImaging PowerDR PACS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LMD	System, Digital Image Communications, Radiological	Radiology	Class 1	892.2020	2022-11-21
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2010-11-29
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2022-01-28
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2022-01-28

Official Correspondent

Chen-Tai MA

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

RADIOLOGY INFORMATION SYSTEMS, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K080013	Agfa Healthcare Corporation	REGISTRATION AND FUSION	2008-01-17
K042221	Barco NV Barcoview	CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM	2004-12-30
K092915	Cedara Software Corp.	CEDARA WEBACCESS, MODEL: 2.4	2010-06-23
K961871	Siemens Medical Solutions USA, Inc.	FLOUROSPOT T.O.P.	1996-07-31
K122260	Aycan Digitalsysteme GmbH	AYCAN MOBILE	2012-09-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2022	GE Healthcare, LLC	2	Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0023-2016	GE Healthcare	2	Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Z-0030-2026	CHANGE HEALTHCARE CANADA COMPANY	2	Change Healthcare Radiology Solutions software version 14.2.2
Z-0032-2012	Philips Healthcare Inc.	2	MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).
Z-0033-2007	AGFA Corp.	2	IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)

Similar Registrations

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3009831823	Trice Imaging, Inc.	Miami, FL, US
3010956703	Visual Medica	Ciudad Autonoma Buenos Aires Buenos Aires, Ciudad Autonoma de, AR
3006619220	Canon Medical Informatics A/S	Valby Hovedstaden, DK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1125622. Last updated year: 2026. Please use registration number 1125622 when referencing this establishment in official correspondence.