The following data is part of a premarket notification filed by Mriaudio with the FDA for Mriaudio Prem System.
| Device ID | K180100 |
| 510k Number | K180100 |
| Device Name: | MRIaudio PREM System |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | MRIaudio 2720 Loker Ave., Suite N Carlsbad, CA 92010 |
| Contact | Joe Caruso |
| Correspondent | Joe Caruso MRIaudio 2720 Loker Ave., Suite N Carlsbad, CA 92010 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-16 |
| Decision Date | 2018-06-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B669SMNS00011 | K180100 | 000 |
| B66914001 | K180100 | 000 |
| B66910001 | K180100 | 000 |
| B66910011 | K180100 | 000 |
| B66910021 | K180100 | 000 |
| B6691011 | K180100 | 000 |
| B66915051 | K180100 | 000 |
| B66915061 | K180100 | 000 |
| B6693020 | K180100 | 000 |
| B6693201 | K180100 | 000 |
| B6693301 | K180100 | 000 |
| B66916001 | K180100 | 000 |