The following data is part of a premarket notification filed by Radmedix Llc with the FDA for Acuitypdr.
| Device ID | K200726 |
| 510k Number | K200726 |
| Device Name: | AcuityPDR |
| Classification | System, X-ray, Mobile |
| 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 | IZL |
| Subsequent Product Code | LLZ |
| Subsequent Product Code | MQB |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-20 |
| Decision Date | 2020-04-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810035220300 | K200726 | 000 |
| 00810035220164 | K200726 | 000 |
| 00810035220157 | K200726 | 000 |
| 00810035220140 | K200726 | 000 |
| 00810035220133 | K200726 | 000 |
| 00810035220126 | K200726 | 000 |
| 00810035220119 | K200726 | 000 |
| 00810035220362 | K200726 | 000 |
| 00810035220355 | K200726 | 000 |
| 00810035220348 | K200726 | 000 |
| 00810035220331 | K200726 | 000 |
| 00810035220171 | K200726 | 000 |
| 00810035220188 | K200726 | 000 |
| 00810035220195 | K200726 | 000 |
| 00810035220294 | K200726 | 000 |
| 00810035220287 | K200726 | 000 |
| 00810035220270 | K200726 | 000 |
| 00810035220263 | K200726 | 000 |
| 00810035220256 | K200726 | 000 |
| 00810035220249 | K200726 | 000 |
| 00810035220232 | K200726 | 000 |
| 00810035220225 | K200726 | 000 |
| 00810035220218 | K200726 | 000 |
| 00810035220201 | K200726 | 000 |
| 00810035220461 | K200726 | 000 |