Clearance Summary
DIGITAL FLAT PANEL X-RAY DETECTOR MODEL SDX-4336CP received FDA 510(k) clearance under submission number K102321, sponsored by Samsung Mobile Display Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2011-02-11.
- Submission: K102321
- Applicant / Sponsor: Samsung Mobile Display Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1680
- Decision date: 2011-02-11
Classification & Regulation
This clearance is catalogued under FDA product code MQB and 21 CFR 892.1680, within the Radiology review panel as a Class II device.