PCA-8000A, MARK 11, PET / CT SYSTEM— 510(k) K082244
Substantially EquivalentToshiba America Medical Systems, In.C
FDA 510(k) clearance K082244 for PCA-8000A, MARK 11, PET / CT SYSTEM, Substantially Equivalent on 2008-08-21. Applicant: Toshiba America Medical Systems, In.C.
Clearance details
- Applicant
- Toshiba America Medical Systems, In.C
- Product code
- Code KPS
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tustin, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.