Clearance Summary
ProRad 2FC and ProRad 3NC Stationary Radiographic Systems received FDA 510(k) clearance under submission number K183541, sponsored by Prognosys Medical Systems Private Limited. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2019-01-24.
- Submission: K183541
- Applicant / Sponsor: Prognosys Medical Systems Private Limited
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1680
- Decision date: 2019-01-24
Classification & Regulation
This clearance is catalogued under FDA product code KPR and 21 CFR 892.1680, within the Radiology review panel as a Class II device.