Medical Device Manufacturer · KR , Seongam-Si

DRTECH Corporation - FDA 510(k) Cleared Devices

26 submissions · 26 cleared · Since 2015

Recent clearances: EXTRON 3, EXTRON 3, EXPD 114

Official Website
26
Total
26
Cleared
0
Denied

FDA 510(k) Regulatory Record - DRTECH Corporation Radiology ✕

26 devices
1-12 of 26
Cleared Aug 19, 2026
EXTRON 3
K261413 · OWB
Radiology · 111d
Cleared Jun 10, 2025
EXTRON 3
K250010 · OWB
Radiology · 159d
Cleared Mar 20, 2025
EXPD 114
K242770 · MQB
Radiology · 188d
Cleared Mar 19, 2025
EXPD 4343N1
K243443 · MQB
Radiology · 133d
Cleared Nov 01, 2024
XERO-alpha
K242591 · EHD
Radiology · 63d
Cleared Oct 23, 2024
EXSYS DEXi (EXSYS DEXi-D401S-FRM)
K242847 · KPR
Radiology · 33d
Cleared Sep 23, 2024
EConsole2
K240243 · LLZ
Radiology · 237d
Cleared Jul 26, 2024
EXSYS DEXi (EXSYS DEXi-D401S-FRM)
K233530 · KPR
Radiology · 267d
Cleared Feb 13, 2024
EXPD 4343S
K232082 · MQB
Radiology · 215d
Cleared Nov 16, 2023
EXPD 4343D
K232753 · MQB
Radiology · 69d
Cleared Oct 18, 2023
EConsole1
K231225 · LLZ
Radiology · 173d
Cleared Aug 17, 2023
EXTRON 5
K230871 · OWB
Radiology · 140d
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