Clearance Summary
MODEL H170 PEDIATRIC CHEST X-RAY UNIT received FDA 510(k) clearance under submission number K915667, sponsored by H.L. Lyons Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1992-01-31.
- Submission: K915667
- Applicant / Sponsor: H.L. Lyons Co.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1880
- Decision date: 1992-01-31
Classification & Regulation
This clearance is catalogued under FDA product code IXY and 21 CFR 892.1880, within the Radiology review panel as a Class I device.