The following data is part of a premarket notification filed by Resoundant Inc with the FDA for Mreplus+ Software.
| Device ID | K183193 |
| 510k Number | K183193 |
| Device Name: | MREplus+ Software |
| Classification | System, Image Processing, Radiological |
| Applicant | Resoundant Inc 421 First Ave SW Suite 204W Rochester, MN 55902 |
| Contact | Bernard Horwath |
| Correspondent | Bernard Horwath HRG 4486 Timberline Ct St. Paul, MN 55127 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-19 |
| Decision Date | 2019-08-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850011790014 | K183193 | 000 |
| 00850011790007 | K183193 | 000 |
| 00850011790199 | K183193 | 000 |