Clearance Summary
dS Sentinelle Breast 16ch 1.5T Coil received FDA 510(k) clearance under submission number K213735, 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 2022-08-08.
- Submission: K213735
- 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: 2022-08-08
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.