OASIS CTL COIL, OD FLEXIBLE BODY COIL (L AND XL), AND RAPID FOOT COIL
FDA 510(k) clearance K073310 · decided 2008-01-18
Clearance details
- K-number
- K073310
- Device name
- OASIS CTL COIL, OD FLEXIBLE BODY COIL (L AND XL), AND RAPID FOOT COIL
- Applicant
- Hitachi Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 2007-11-23
- Decision date
- 2008-01-18
- Days to decision
- 56 days
- Clearance type
- Abbreviated
- Product code
- MOS
- Device class
- 2
- Regulation number
- 892.1000
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Twinsburg, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.