Clearance Summary
DC-7 DIAGNOSTIC ULTRASOUND SYSTEM received FDA 510(k) clearance under submission number K101041, sponsored by Shenzhen Mindray Bio-Medical Electronics 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 2010-04-30.
- Submission: K101041
- Applicant / Sponsor: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1570
- Decision date: 2010-04-30
Classification & Regulation
This clearance is catalogued under FDA product code ITX and 21 CFR 892.1570, within the Radiology review panel as a Class II device.