Medical Device Manufacturer · US , Flintville , TN

Mcube Technology Co., Ltd. - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 2009

Recent clearances: CUBEScan BioCon-1100, CUBEScan BioCon-900S, CUBEScan BioCon-1100

6
Total
6
Cleared
0
Denied

FDA 510(k) Regulatory Record - Mcube Technology Co., Ltd. Radiology ✕

6 devices
1-6 of 6
Cleared Aug 19, 2020
CUBEScan BioCon-1100
K201995 · IYO
Radiology · 30d
Cleared May 19, 2020
CUBEScan BioCon-900S
K200749 · IYO
Radiology · 57d
Cleared Mar 27, 2020
CUBEScan BioCon-1100
K200548 · IYO
Radiology · 24d
Cleared Jun 22, 2017
CUBEScan™ BioCon-900 (Bladder Volume Measurement System)
K171591 · IYO
Radiology · 22d
Cleared Apr 27, 2011
CUBESCAN / BIOCON-700
K111021 · ITX
Radiology · 15d
Cleared Jun 18, 2009
CUBESCAN BIOCON-500 DIAGNOSTIC ULTRASOUND SYSTEM
K091518 · IYO
Radiology · 27d
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