The following data is part of a premarket notification filed by Multimodal Imaging Services Corporation (dba Healthlytix) with the FDA for Rsi-mri+.
| Device ID | K191278 |
| 510k Number | K191278 |
| Device Name: | RSI-MRI+ |
| Classification | System, Image Processing, Radiological |
| Applicant | MultiModal Imaging Services Corporation (dba HealthLytix) 4747 Executive Dr, Suite 820 San Diego, CA 92121 |
| Contact | Stephen Kosnosky |
| Correspondent | Stephen Kosnosky MultiModal Imaging Services Corporation (dba HealthLytix) 4747 Executive Dr, Suite 820 San Diego, CA 92121 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-13 |
| Decision Date | 2019-11-19 |
| Summary: | summary |