Medical Device Manufacturer · US , Menlo Park , CA

Subtle Medical, Inc. - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 2018
9
Total
9
Cleared
0
Denied

FDA 510(k) cleared devices by Subtle Medical, Inc. Radiology ✕

9 devices
1-9 of 9
Cleared Feb 12, 2025
SubtleHD (1.x)
K243250 · QIH
Radiology · 120d
Cleared Aug 21, 2024
AiMIFY (1.x)
K240290 · LLZ
Radiology · 202d
Cleared Jul 11, 2024
SubtleSYNTH (1.x)
K241329 · QIH
Radiology · 62d
Cleared Apr 29, 2024
SubtleREFORMAT (1.x)
K233699 · LLZ
Radiology · 164d
Cleared May 11, 2023
SubtleMR (2.3.x)
K223623 · LLZ
Radiology · 157d
Cleared Sep 28, 2021
SubtlePET
K211964 · KPS
Radiology · 96d
Cleared Feb 26, 2021
SubtleMR
K203182 · LLZ
Radiology · 122d
Cleared Sep 16, 2019
SubtleMR
K191688 · LLZ
Radiology · 84d
Cleared Nov 30, 2018
SubtlePET
K182336 · KPS
Radiology · 94d
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