Clearance Summary
INSTARAD received FDA 510(k) clearance under submission number K080334, sponsored by Medsphere Technologies Pvt , 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 2008-02-21.
- Submission: K080334
- Applicant / Sponsor: Medsphere Technologies Pvt , Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2008-02-21
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.