The following data is part of a premarket notification filed by Quality Electrodynamics with the FDA for Toshiba 3t 32ch Head Speeder Coil,.
| Device ID | K122638 |
| 510k Number | K122638 |
| Device Name: | TOSHIBA 3T 32CH HEAD SPEEDER COIL, |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | QUALITY ELECTRODYNAMICS 700 BETA DRIVE SUITE 100 Mayfield Village, OH 44143 -0000 |
| Contact | Kathleen Aras |
| Correspondent | Kathleen Aras QUALITY ELECTRODYNAMICS 700 BETA DRIVE SUITE 100 Mayfield Village, OH 44143 -0000 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-29 |
| Decision Date | 2012-09-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814848020188 | K122638 | 000 |