Clearance Summary
GEHC DXA Bone Densitometers with enCORE version 18 received FDA 510(k) clearance under submission number K191112, sponsored by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2019-09-19.
- Submission: K191112
- Applicant / Sponsor: GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1170
- Decision date: 2019-09-19
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.