Clearance Summary
ESP SERIES (X-RAY GENERATORS received FDA 510(k) clearance under submission number K820593, sponsored by Xonics Medical Systems, 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 1982-03-19.
- Submission: K820593
- Applicant / Sponsor: Xonics Medical Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1700
- Decision date: 1982-03-19
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.