Clearance Summary
FS-PACS received FDA 510(k) clearance under submission number K152034, sponsored by Ec-Web 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 2016-02-23.
- Submission: K152034
- Applicant / Sponsor: Ec-Web Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2016-02-23
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.