K244054
- 510(k) number
- K244054
- Device name
- 16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247)
- Applicant
- Quality Electrodynamics OH · US
- Product code
- MOS — Coil, Magnetic Resonance, Specialty
- Decision date
- 2025-02-28
- Date received
- 2024-12-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.1 MB · U.S. public domain
Also available from FDA: K244054.pdf
Official FDA record: K244054
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.