Clearance Summary
UNISIGHT SYSTEM WITH UNIGATE received FDA 510(k) clearance under submission number K023394, sponsored by Electronic Business Machine Co., Ltd. (Ebm). The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2003-01-07.
- Submission: K023394
- Applicant / Sponsor: Electronic Business Machine Co., Ltd. (Ebm)
- Clearance pathway: Abbreviated
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2003-01-07
Classification & Regulation
This clearance is catalogued under FDA product code LLZ and 21 CFR 892.2050, within the Radiology review panel as a Class II device.