K244054 is an FDA 510(k) clearance for the 16ch Flex SPEEDER Medium 1.5T (Q7000246). This device is classified as a Coil, Magnetic Resonance, Specialty (Class II - Special Controls, product code MOS).
Submitted by Quality Electrodynamics (Mayfield Village, US). The FDA issued a Cleared decision on February 28, 2025, 59 days after receiving the submission on December 31, 2024.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1000.
| 510(k) Number | K244054 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 31, 2024 |
| Decision Date | February 28, 2025 |
| Days to Decision | 59 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | MOS - Coil, Magnetic Resonance, Specialty |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1000 |