Company profile

Subtle Medical, Inc.

Subtle Medical, Inc. has 10 AI-enabled medical devices on the FDA list. The first decision was on November 30, 2018 and the most recent on May 15, 2026 (SubtleHD-CT (1.x)). Its most common review panel is Radiology (10 devices).

10AI devices

2018First decision

2026Latest decision

1Specialties

Per year

2018201920212023202420252026

Subtle Medical, Inc. AI devices per year: 2018 1, 2019 1, 2021 2, 2023 1, 2024 2, 2025 1, 2026 2

By specialty

Radiology10

Related guides

Top radiology devices

Timeline

May 15, 2026 · 510(k) K254120SubtleHD-CT (1.x) · Radiology · QIH
May 14, 2026 · 510(k) K254013SubtleHD-PET (1.x) · Radiology · LLZ
February 12, 2025 · 510(k) K243250SubtleHD (1.x) · Radiology · QIH
August 21, 2024 · 510(k) K240290AiMIFY (1.x) · Radiology · LLZ
July 11, 2024 · 510(k) K241329SubtleSYNTH (1.x) · Radiology · QIH
May 11, 2023 · 510(k) K223623SubtleMR (2.3.x) · Radiology · LLZ
September 28, 2021 · 510(k) K211964SubtlePET · Radiology · KPS
February 26, 2021 · 510(k) K203182SubtleMR · Radiology · LLZ
September 16, 2019 · 510(k) K191688SubtleMR · Radiology · LLZ
November 30, 2018 · 510(k) K182336SubtlePET · Radiology · KPS