PennPET Explorer Positron Emission Tomograph— 510(k) K251401
Substantially EquivalentTrustees of the University of Pennsylvania
FDA 510(k) clearance K251401 for PennPET Explorer Positron Emission Tomograph, Substantially Equivalent on 2025-11-25. Applicant: Trustees of the University of Pennsylvania. Device class: 2.
Clearance details
- Applicant
- Trustees of the University of Pennsylvania
- 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
- Traditional
- Location
- Philadelphia, PA, US
Recent devices under product code KPS
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