Clearance Summary
ES1 System received FDA 510(k) clearance under submission number K213102, sponsored by E-Scopics. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2022-01-11.
- Submission: K213102
- Applicant / Sponsor: E-Scopics
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1550
- Decision date: 2022-01-11
Classification & Regulation
This clearance is catalogued under FDA product code IYN and 21 CFR 892.1550, within the Radiology review panel as a Class II device.