Clearance Summary
ds Head 32ch 3.0T received FDA 510(k) clearance under submission number K213351, sponsored by Invivo Corporation (Business Trade Name: Philips). The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2021-10-29.
- Submission: K213351
- Applicant / Sponsor: Invivo Corporation (Business Trade Name: Philips)
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1000
- Decision date: 2021-10-29
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.