Subtle Medical, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
11
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K254120SubtleHD-CT (1.x)May 15, 2026
K254013SubtleHD-PET (1.x)May 14, 2026
K243250SubtleHD (1.x)February 12, 2025
K240290AiMIFY (1.x)August 21, 2024
K241329SubtleSYNTH (1.x)July 11, 2024
K233699SubtleREFORMAT (1.x)April 29, 2024
K223623SubtleMR (2.3.x)May 11, 2023
K211964SubtlePETSeptember 28, 2021
K203182SubtleMRFebruary 26, 2021
K191688SubtleMRSeptember 16, 2019
K182336SubtlePETNovember 30, 2018