CUBEScan™ BioCon-900 (Bladder Volume Measurement System)

System, Imaging, Pulsed Echo, Ultrasonic

Mcube Technology Co., Ltd.

The following data is part of a premarket notification filed by Mcube Technology Co., Ltd. with the FDA for Cubescan™ Biocon-900 (bladder Volume Measurement System).

Pre-market Notification Details

• Device ID: K171591
• 510k Number: K171591
• Device Name: CUBEScan™ BioCon-900 (Bladder Volume Measurement System)
• Classification: System, Imaging, Pulsed Echo, Ultrasonic
• Applicant: Mcube Technology Co., Ltd. #803, 123, Bonghwasan-ro Jungnang-gu, Seoul, Korea Seoul, KR 02048
• Contact: Changhyun Kim
• Correspondent: Dave Yungvirt; THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059
• Product Code: IYO
• CFR Regulation Number: 892.1560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2017-05-31
• Decision Date: 2017-06-22
• Summary: summary