The following data is part of a premarket notification filed by Resonance Innovations Llc with the FDA for 3.0t Pediatric Head And Spine Array, Model 808ge3000.
| Device ID | K061170 |
| 510k Number | K061170 |
| Device Name: | 3.0T PEDIATRIC HEAD AND SPINE ARRAY, MODEL 808GE3000 |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | RESONANCE INNOVATIONS LLC 12530 HARNEY CIRCLE Omaha, NE 68154 |
| Contact | Randall Jones |
| Correspondent | Randall Jones RESONANCE INNOVATIONS LLC 12530 HARNEY CIRCLE Omaha, NE 68154 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-27 |
| Decision Date | 2006-05-25 |
| Summary: | summary |