The following data is part of a premarket notification filed by Radmedix Llc with the FDA for Acuitydre.
| Device ID | K210919 |
| 510k Number | K210919 |
| Device Name: | AcuityDRe |
| 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 45409 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-29 |
| Decision Date | 2021-04-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810035220447 | K210919 | 000 |
| 00810035220485 | K210919 | 000 |
| 00810035220478 | K210919 | 000 |