CUBEScan BioCon-1100
FDA 510(k) K200548 · Mcube Technology Co., Ltd.
510(k) numberK200548
Submission
- Device name
- CUBEScan BioCon-1100
- Applicant
- Mcube Technology Co., Ltd.
Seoul, KR - Received
- March 3, 2020
- Decision date
- March 27, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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More from Accutome, Inc. Doing Business AS Keeler USA
| 510(k) | Device | Decision |
|---|---|---|
| K201995 | CUBEScan BioCon-1100IYO · Special | 08/19/2020SE |
| K200749 | CUBEScan BioCon-900SIYO · Traditional | 05/19/2020SE |
| K171591 | CUBEScan BioCon-900 (Bladder Volume Measurement System)IYO · Traditional | 06/22/2017SE |
| K111021 | Cubescan / BIOCON-700ITX · Traditional | 04/27/2011SE |
| K091518 | Cubescan BIOCON-500 Diagnostic Ultrasound SystemIYO · Traditional | 06/18/2009SE |
Questions and answers
When was CUBEScan BioCon-1100 cleared by the FDA?
CUBEScan BioCon-1100 (K200548) received a 510(k) decision of Substantially Equivalent on March 27, 2020, 24 days after the submission was received.
What is the product code of K200548?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.