Medical Device Manufacturer · KR , Seoul

JLK, Inc. - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 2024

Recent clearances: JLK-NCCT, JLK-SDH, JLK-AILink

8
Total
8
Cleared
0
Denied

FDA 510(k) Regulatory Record - JLK, Inc. Radiology ✕

8 devices
1-8 of 8
Cleared Mar 24, 2026
JLK-NCCT
K252421 · QAS
Radiology · 235d
Cleared Mar 03, 2025
JLK-SDH
K243611 · QAS
Radiology · 101d
Cleared Feb 25, 2025
JLK-AILink
K250348 · LLZ
Radiology · 19d
Cleared Jan 03, 2025
JLK-ICH
K243363 · QAS
Radiology · 66d
Cleared Nov 04, 2024
JLK-PWI
K242709 · LLZ
Radiology · 56d
Cleared Oct 16, 2024
JLK-CTP
K242556 · LLZ
Radiology · 49d
Cleared Sep 27, 2024
JBS-LVO
K241480 · QAS
Radiology · 126d
Cleared Jun 21, 2024
Medihub Prostate
K233196 · QIH
Radiology · 267d
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