The following data is part of a premarket notification filed by Quality Electrodynamics with the FDA for Toshiba 1.5t Extra Large Knee Coil.
| Device ID | K103185 |
| 510k Number | K103185 |
| Device Name: | TOSHIBA 1.5T EXTRA LARGE KNEE COIL |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | QUALITY ELECTRODYNAMICS 700 BETA DR. SUITE 100 Mayfield Village, OH 44143 |
| Contact | Christie Zydyk |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-10-28 |
| Decision Date | 2011-02-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814848020034 | K103185 | 000 |