Clearance Summary
POLARIX 2 AND POLARIX 2E received FDA 510(k) clearance under submission number K884578, sponsored by Dyna-Med. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1989-02-09.
- Submission: K884578
- Applicant / Sponsor: Dyna-Med
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1650
- Decision date: 1989-02-09
Classification & Regulation
This clearance is catalogued under FDA product code JAA and 21 CFR 892.1650, within the Radiology review panel as a Class II device.