1.5T ATLAS SPEEDER HEAD-NECK COIL
FDA 510(k) clearance K083160 · decided 2008-11-07
Clearance details
- K-number
- K083160
- Device name
- 1.5T ATLAS SPEEDER HEAD-NECK COIL
- Applicant
- Quality Electrodynamics
- Decision
- Substantially Equivalent
- Date received
- 2008-10-27
- Decision date
- 2008-11-07
- Days to decision
- 11 days
- Clearance type
- Traditional
- Product code
- MOS
- Device class
- 2
- Regulation number
- 892.1000
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Mayfield Village, OH, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Mirror assembly to magnetic resonance device (1.5T Atlas SPEEDER Head-Neck Coil) Coil Part recall (Z-1938-2009) | Quality Electrodynamics Llc | 2009-09-10 |