Clearance Summary
HTS ARRAY COIL received FDA 510(k) clearance under submission number K030540, sponsored by Jockey Club Mri Engineering Center. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2003-04-16.
- Submission: K030540
- Applicant / Sponsor: Jockey Club Mri Engineering Center
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1000
- Decision date: 2003-04-16
Classification & Regulation
This clearance is catalogued under FDA product code MOS and 21 CFR 892.1000, within the Radiology review panel as a Class II device.