The following data is part of a premarket notification filed by Radmedix Llc with the FDA for Accuvue+.
| Device ID | K201058 |
| 510k Number | K201058 |
| Device Name: | Accuvue+ |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | Radmedix LLC 2510 Lance Dr. Dayton, OH 45409 |
| Contact | Gabriel Issa |
| Correspondent | Daniel Kamm Kamm & Associates 8870 Ravello Ct Naples, FL 34114 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-21 |
| Decision Date | 2020-05-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810035220379 | K201058 | 000 |