Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Subtle Medical with 11 510(k) clearances and 10 AI-enabled devices. The most recent is a 510(k) clearance dated May 15, 2026: SubtleHD-CT (1.x).
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| May 15, 2026 | SubtleHD-CT (1.x)K254120 · QIH | 510(k) clearances |
| May 15, 2026 | SubtleHD-CT (1.x)K254120 · Radiology | AI-enabled devices |
| May 14, 2026 | SubtleHD-PET (1.x)K254013 · LLZ | 510(k) clearances |
| May 14, 2026 | SubtleHD-PET (1.x)K254013 · Radiology | AI-enabled devices |
| Feb 12, 2025 | SubtleHD (1.x)K243250 · QIH | 510(k) clearances |
| Feb 12, 2025 | SubtleHD (1.x)K243250 · Radiology | AI-enabled devices |
| Aug 21, 2024 | AiMIFY (1.x)K240290 · LLZ | 510(k) clearances |
| Aug 21, 2024 | AiMIFY (1.x)K240290 · Radiology | AI-enabled devices |
| Jul 11, 2024 | SubtleSYNTH (1.x)K241329 · QIH | 510(k) clearances |
| Jul 11, 2024 | SubtleSYNTH (1.x)K241329 · Radiology | AI-enabled devices |
| Apr 29, 2024 | SubtleREFORMAT (1.x)K233699 · LLZ | 510(k) clearances |
| May 11, 2023 | SubtleMR (2.3.x)K223623 · LLZ | 510(k) clearances |
| May 11, 2023 | SubtleMR (2.3.x)K223623 · Radiology | AI-enabled devices |
| Sep 28, 2021 | SubtlePETK211964 · KPS | 510(k) clearances |
| Sep 28, 2021 | SubtlePETK211964 · Radiology | AI-enabled devices |
| Feb 26, 2021 | SubtleMRK203182 · Radiology | AI-enabled devices |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
