K253714
- 510(k) number
- K253714
- Device name
- IntraSight Plus
- Applicant
- Philips Image Guided Therapy Corporation CO · US
- Product code
- IYO — System, Imaging, Pulsed Echo, Ultrasonic
- Decision date
- 2026-02-24
- Date received
- 2025-11-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K253714.pdf
Official FDA record: K253714
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.