K253532
- 510(k) number
- K253532
- Device name
- TruSPECT Processing Station
- Applicant
- Spectrum Dynamics Medical, Ltd. IL
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2025-12-30
- Date received
- 2025-11-13
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K253532.pdf
Official FDA record: K253532
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.