GE POSITRACE/DISCOVERY VI PET/CT DUAL MODE ONCOLOGY SCANNER— 510(k) K012775
Substantially EquivalentGE Medical Systems
FDA 510(k) clearance K012775 for GE POSITRACE/DISCOVERY VI PET/CT DUAL MODE ONCOLOGY SCANNER, Substantially Equivalent on 2001-09-18. Applicant: GE Medical Systems. Device class: 2.
Clearance details
- Applicant
- GE Medical Systems
- Product code
- Code KPS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1200
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Twinsburg, OH, US
Recent devices under product code KPS
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