Clearance Summary
GEN-X 800/800 received FDA 510(k) clearance under submission number K914301, sponsored by Swissray Finatech, 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 1991-10-30.
- Submission: K914301
- Applicant / Sponsor: Swissray Finatech, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1700
- Decision date: 1991-10-30
Classification & Regulation
This clearance is catalogued under FDA product code IZO and 21 CFR 892.1700, within the Radiology review panel as a Class I device.