K253963
- 510(k) number
- K253963
- Device name
- Cubresa BrainPET
- Applicant
- Cubresa, Inc. CA
- Product code
- OUO — Tomographic Imager Combining Emission Computed Tomog
- Decision date
- 2026-07-17
- Date received
- 2025-12-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K253963.pdf
Official FDA record: K253963
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.