Clearance Summary
DRX-EVOLUTION, MODEL VX3733-SYS received FDA 510(k) clearance under submission number K091889, sponsored by Carestream Health, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2009-07-20.
- Submission: K091889
- Applicant / Sponsor: Carestream Health, Inc.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1680
- Decision date: 2009-07-20
Classification & Regulation
This clearance is catalogued under FDA product code KPR and 21 CFR 892.1680, within the Radiology review panel as a Class II device.