The following data is part of a premarket notification filed by Resonance Innovations Llc with the FDA for 1.5t Procure Array Coil, 3.0t Procure Array Coil.
| Device ID | K140606 |
| 510k Number | K140606 |
| Device Name: | 1.5T PROCURE ARRAY COIL, 3.0T PROCURE ARRAY COIL |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | RESONANCE INNOVATIONS LLC 9840 S. 140TH ST. Omaha, NE 68138 -3693 |
| Contact | Randall Jones |
| Correspondent | Randall Jones RESONANCE INNOVATIONS LLC 9840 S. 140TH ST. Omaha, NE 68138 -3693 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-10 |
| Decision Date | 2014-05-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859193006456 | K140606 | 000 |
| 00859193006449 | K140606 | 000 |
| 00859193006425 | K140606 | 000 |
| 00859193006371 | K140606 | 000 |
| 00859193006203 | K140606 | 000 |
| 00859193006197 | K140606 | 000 |
| 00859193006128 | K140606 | 000 |
| 00859193006111 | K140606 | 000 |