Clearance Summary
PRONOSCO X-POSURE SYSTEM received FDA 510(k) clearance under submission number K984178, sponsored by Torsana Osteoporosis Diagnostics A/S. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1999-02-18.
- Submission: K984178
- Applicant / Sponsor: Torsana Osteoporosis Diagnostics A/S
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1170
- Decision date: 1999-02-18
Classification & Regulation
This clearance is catalogued under FDA product code KGI and 21 CFR 892.1170, within the Radiology review panel as a Class II device.