Clearance Summary
CRONEX QUANTA RAPID SR397 RARE EARTH INTENS SCREEN received FDA 510(k) clearance under submission number K900448, sponsored by E.I. Dupont DE Nemours & Co., 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 1990-02-16.
- Submission: K900448
- Applicant / Sponsor: E.I. Dupont DE Nemours & Co., Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1960
- Decision date: 1990-02-16
Classification & Regulation
This clearance is catalogued under FDA product code EAM and 21 CFR 892.1960, within the Radiology review panel as a Class I device.