Clearance Summary
Spectral CT received FDA 510(k) clearance under submission number K244008, sponsored by Philips Medical Systems Technologies , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2025-05-16.
- Submission: K244008
- Applicant / Sponsor: Philips Medical Systems Technologies , Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1750
- Decision date: 2025-05-16
Classification & Regulation
This clearance is catalogued under FDA product code JAK and 21 CFR 892.1750, within the Radiology review panel as a Class II device.