Clearance Summary
DIGITAL X-RAY DETECTORS FAMILY KRC AND DIRA received FDA 510(k) clearance under submission number K093640, sponsored by Electron Jsco.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2011-04-29.
- Submission: K093640
- Applicant / Sponsor: Electron Jsco.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1630
- Decision date: 2011-04-29
Classification & Regulation
This clearance is catalogued under FDA product code IXK and 21 CFR 892.1630, within the Radiology review panel as a Class II device.