MODEL TSX-101A/H/I AQUILION 32/64 SP CT SYSTEM
FDA 510(k) clearance K080211 · decided 2008-03-14
Clearance details
- K-number
- K080211
- Device name
- MODEL TSX-101A/H/I AQUILION 32/64 SP CT SYSTEM
- Applicant
- Toshiba America Medical Systems, In.C
- Decision
- Substantially Equivalent
- Date received
- 2008-01-29
- Decision date
- 2008-03-14
- Days to decision
- 45 days
- Clearance type
- Traditional
- Product code
- JAK
- Device class
- 2
- Regulation number
- 892.1750
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Tustin, CA, US
- Third-party review
- Yes
- Expedited review
- No
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