Clearance Summary
STATIONARY X-RAY SYSTEM (DETECTOR) MODEL: ALTAS received FDA 510(k) clearance under submission number K100703, sponsored by Comed 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 2010-12-21.
- Submission: K100703
- Applicant / Sponsor: Comed Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1680
- Decision date: 2010-12-21
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.