Clearance Summary
SPECTRUM PEDIATRIC CARDLE TABLE received FDA 510(k) clearance under submission number K813561, sponsored by Spectrum X-Ray Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1982-01-29.
- Submission: K813561
- Applicant / Sponsor: Spectrum X-Ray Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1830
- Decision date: 1982-01-29
Classification & Regulation
This clearance is catalogued under FDA product code KXH and 21 CFR 892.1830, within the Radiology review panel as a Class I device.