Clearance Summary
3DI INCLUDING CSCORE received FDA 510(k) clearance under submission number K112530, sponsored by Shina Systems , 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 2011-09-30.
- Submission: K112530
- Applicant / Sponsor: Shina Systems , Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2011-09-30
Classification & Regulation
This clearance is catalogued under FDA product code LLZ and 21 CFR 892.2050, within the Radiology review panel as a Class II device.