Clearance Summary
Sentinella 102, Sentinella 102 Horus received FDA 510(k) clearance under submission number K162052, sponsored by General Equipment For Medical Imaging (Oncovision-. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2016-08-18.
- Submission: K162052
- Applicant / Sponsor: General Equipment For Medical Imaging (Oncovision-
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1100
- Decision date: 2016-08-18
Classification & Regulation
This clearance is catalogued under FDA product code IYX and 21 CFR 892.1100, within the Radiology review panel as a Class I device.