Data / Medical devices / United States / Radiology Information Systems, Inc.
Radiology Information Systems, Inc.: FDA-registered device maker in Dulles, VA, United States, 2 510(k) clearances
Radiology Information Systems, Inc. is registered with the FDA (registration 1125622) in Dulles, VA, United States. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 16, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1125622
- FEI number
- 3002952981
- Address
- 43676 Trade Center Place Suite 100, Dulles, VA, United States, 20166
- Owner or operator
- RADIOLOGY INFORMATION SYSTEMS, INC. (9029503)
- Roles
- Manufacturer
- First device listed
- November 29, 2010
- Registered through
- 2026
- Brand names listed
- AccuImaging, PowerDR PACS, RSVS
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | 2 | Manufacturer | accessdata.fda.gov |
| System, Digital Image Communications, Radiological | LMD | 1 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 16, 2019 | K191504 | PowerDR | JAA | Substantially Equivalent | Radiology Information Systems, Inc. | accessdata.fda.gov |
| November 23, 2010 | K102849 | ACCULMAING | LLZ | Substantially Equivalent | Radiology Information Systems, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, X-Ray, Fluoroscopic, Image-Intensified
- All makers of Solid State X-Ray Imager (Flat Panel/Digital Imager)
- All makers of System, Digital Image Communications, Radiological
- All makers of System, Image Processing, Radiological
Updated August 16, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.