CLEARVIEW

System, X-ray, Tomography, Computed

NEUSOFT MEDICAL SYSTEMS CO., LTD.

The following data is part of a premarket notification filed by Neusoft Medical Systems Co., Ltd. with the FDA for Clearview.

Pre-market Notification Details

• Device ID: K133373
• 510k Number: K133373
• Device Name: CLEARVIEW
• Classification: System, X-ray, Tomography, Computed
• Applicant: NEUSOFT MEDICAL SYSTEMS CO., LTD. NO. 16, SHIJI ROAD HUNNAN INDUSTRIAL AREA Shenyang, Liaoning, CN 110179
• Contact: Tian Yuehui
• Correspondent: Tian Yuehui; NEUSOFT MEDICAL SYSTEMS CO., LTD. NO. 16, SHIJI ROAD HUNNAN INDUSTRIAL AREA Shenyang, Liaoning, CN 110179
• Product Code: JAK
• CFR Regulation Number: 892.1750 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-11-01
• Decision Date: 2014-12-03
• Summary: summary