K251401
- 510(k) number
- K251401
- Device name
- PennPET Explorer Positron Emission Tomograph
- Applicant
- Trustees of the University of Pennsylvania PA · US
- Product code
- KPS — System, Tomography, Computed, Emission
- Decision date
- 2025-11-25
- Date received
- 2025-05-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K251401.pdf
Official FDA record: K251401
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.