Clearance Summary
SET-5002 received FDA 510(k) clearance under submission number K240827, sponsored by Shimadzu Corporation Medical Systems Division. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2024-05-24.
- Submission: K240827
- Applicant / Sponsor: Shimadzu Corporation Medical Systems Division
- Clearance pathway: Abbreviated
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1200
- Decision date: 2024-05-24
Classification & Regulation
This clearance is catalogued under FDA product code KPS and 21 CFR 892.1200, within the Radiology review panel as a Class II device.