PowerDR
System, X-ray, Fluoroscopic, Image-intensified
Radiology Information Systems, Inc.
The following data is part of a premarket notification filed by Radiology Information Systems, Inc. with the FDA for Powerdr.
Pre-market Notification Details
| Device ID | K191504 |
| 510k Number | K191504 |
| Device Name: | PowerDR |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | Radiology Information Systems, Inc. 43676 Trade Center Place, Ste 100 Dulles, VA 20166 |
| Contact | Chen-tai Ma |
| Correspondent | Daniel Kamm Kamm & Associates 8870 Ravello Ct. Naples, FL 34114 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-06 |
| Decision Date | 2019-08-16 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860009490604 | K191504 | 000 |
Trademark Results [PowerDR]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 POWERDR 88383755 5890399 Live/Registered |
Radiology Information Systems, Inc. 2019-04-12 |
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