Clearance Summary
X-RAY APRON received FDA 510(k) clearance under submission number K870563, sponsored by X-Tech, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1987-02-19.
- Submission: K870563
- Applicant / Sponsor: X-Tech, Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.6500
- Decision date: 1987-02-19
Classification & Regulation
This clearance is catalogued under FDA product code EAJ and 21 CFR 892.6500, within the Radiology review panel as a Class I device.