Clearance Summary
PEDIATRIC POSITIONER PAD SET received FDA 510(k) clearance under submission number K122174, sponsored by Ge Healthcare Coils (Usa Instruments, 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 2012-11-16.
- Submission: K122174
- Applicant / Sponsor: Ge Healthcare Coils (Usa Instruments, Inc.)
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1830
- Decision date: 2012-11-16
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.