The following data is part of a premarket notification filed by Resonance Health Analysis Services Pty Ltd with the FDA for Mri-q System.
| Device ID | K111222 |
| 510k Number | K111222 |
| Device Name: | MRI-Q SYSTEM |
| Classification | System, Image Processing, Radiological |
| Applicant | RESONANCE HEALTH ANALYSIS SERVICES PTY LTD 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Contact | Greg Holland |
| Correspondent | Greg Holland RESONANCE HEALTH ANALYSIS SERVICES PTY LTD 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-02 |
| Decision Date | 2011-07-28 |
| Summary: | summary |