SCATTER CORRECTION VOLUME SOFTWARE MODEL NSSC-020A
FDA 510(k) clearance K960948 · decided 1996-12-23
Clearance details
- K-number
- K960948
- Device name
- SCATTER CORRECTION VOLUME SOFTWARE MODEL NSSC-020A
- Applicant
- Toshiba Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 1996-03-08
- Decision date
- 1996-12-23
- Days to decision
- 290 days
- Clearance type
- Traditional
- Product code
- KPS
- Device class
- 2
- Regulation number
- 892.1200
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Tustin, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.