Clearance Summary
RADSTAR FAMILY, MODELS: RADSTAR 4343 & VARIATIONS received FDA 510(k) clearance under submission number K083645, sponsored by 5 Star Medical, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2009-02-24.
- Submission: K083645
- Applicant / Sponsor: 5 Star Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1680
- Decision date: 2009-02-24
Classification & Regulation
This clearance is catalogued under FDA product code MQB and 21 CFR 892.1680, within the Radiology review panel as a Class II device.