Clearance Summary
BRACHYSEED PD-103 MODELS #PD1 received FDA 510(k) clearance under submission number K011119, sponsored by Draximage, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2001-06-25.
- Submission: K011119
- Applicant / Sponsor: Draximage, Inc.
- Clearance pathway: Abbreviated
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5730
- Decision date: 2001-06-25
Classification & Regulation
This clearance is catalogued under FDA product code KXK and 21 CFR 892.5730, within the Radiology review panel as a Class II device.