The following data is part of a premarket notification filed by Mri-tech Sp. Zo.o. with the FDA for Cirrus Open.
| Device ID | K090080 |
| 510k Number | K090080 |
| Device Name: | CIRRUS OPEN |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | MRI-TECH SP. ZO.O. 206 - 3820 CAMBIE STREET Vancouver, Bc, CA V5z 2x7 |
| Contact | Anita Chan |
| Correspondent | Anita Chan MRI-TECH SP. ZO.O. 206 - 3820 CAMBIE STREET Vancouver, Bc, CA V5z 2x7 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-12 |
| Decision Date | 2009-03-23 |
| Summary: | summary |