The following data is part of a premarket notification filed by Radmedix Llc with the FDA for Acuity Sdr Standard, Acuity Sdr Plus, Acuity Fdr Standard.
| Device ID | K193360 |
| 510k Number | K193360 |
| Device Name: | Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard |
| Classification | System, X-ray, Stationary |
| 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 | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-04 |
| Decision Date | 2020-01-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810035220041 | K193360 | 000 |
| 00810035220317 | K193360 | 000 |
| 00810035220324 | K193360 | 000 |
| 00810035220065 | K193360 | 000 |
| 00810035220072 | K193360 | 000 |
| 00810035220089 | K193360 | 000 |
| 00810035220096 | K193360 | 000 |
| 00810035220102 | K193360 | 000 |
| 00810035220058 | K193360 | 000 |
| 00810035220003 | K193360 | 000 |
| 00810035220010 | K193360 | 000 |
| 00810035220027 | K193360 | 000 |
| 00810035220034 | K193360 | 000 |
| 00810035220454 | K193360 | 000 |