16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247)
Quality Electrodynamics · Radiology
Open FDA's page for this record- Third party flag
- N
- City
- Mayfield Village
- Advisory committee description
- Radiology
- Address 1
- 6655 Beta Dr.
- Address 2
- Suite 100
- Statement or summary
- Summary
- Product code
- MOS
- Zip code
- 44122
- Applicant
- Quality Electrodynamics
- Decision date
- 2025-02-28
- Decision code
- SESE
- Country code
- US
- Device name
- 16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247)
- Advisory committee
- RA
- Contact
- JoVanna Boudreaux
- K number
- K244054
- State
- OH
- Date received
- 2024-12-31
- Review advisory committee
- RA
- Postal code
- 44122
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Coil, Magnetic Resonance, Specialty
- Medical specialty description
- Radiology
- Regulation number
- 892.1000
- Device class
- 2
- Registration number
- 3014635027, 3028006458, 3018423337, 3010326005, 3010703925, 3003768277, 3029521953, 3014310698, 3017375271, 3007137598, 3006369484, 3002808157, 3026047529, 3008284470, 3009196578, 3013343065, 3009755250, 3031503890, 3042177665, 3008414621, 3009714754, 3011015597, 3006239787, 3004977335, 1932898, 3014343100, 3010949642, 1058584, 3009970070, 3027339477, 3000126629, 3012085143, 3008355361, 3035950510, 3012439308, 3015431711, 3009514037, 3005326970, 3004754211, 3010132318 +38 more
- FEI number
- 3014635027, 3028006458, 3005214683, 3018423337, 3010326005, 3010703925, 3029521953, 3014310698, 3017375271, 3007137598, 1000571342, 3003377038, 3006369484, 3002808157, 3002808382, 3026047529, 3008284470, 3009196578, 3013343065, 3009755250, 3031503890, 3042177665, 3008414621, 3009714754, 3011015597, 3006239787, 3004977335, 3001814065, 3014343100, 3010949642, 3009970070, 3027339477, 3000126629, 3012085143, 3008355361, 3035950510, 3012439308, 3015431711, 3009514037, 3005326970 +38 more