Clearance Summary
Models 3543A, 4343A, 2929A and A843B received FDA 510(k) clearance under submission number K170480, sponsored by Shanghai PZ Medical Technolgoy 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 2017-07-07.
- Submission: K170480
- Applicant / Sponsor: Shanghai PZ Medical Technolgoy Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1680
- Decision date: 2017-07-07
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.