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

Cleared May 15, 2026

SubtleHD-CT (1.x)

K254120 · QIH

Radiology · 147d

Cleared May 14, 2026

SubtleHD-PET (1.x)

K254013 · LLZ

Radiology · 150d

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