Transparency Registry · applicant
Subtle Medical, Inc.: 3 FDA AI clearances
Every 510(k) clearance held by Subtle Medical, Inc. under the AI-associated product codes this registry tracks, from openFDA public records, refreshed weekly. Facts only; listing is not evaluation.
| Device | Decision date | Category |
|---|---|---|
| SubtleHD-CT (1.x) | 2026-05-15 | QIH |
| SubtleHD (1.x) | 2025-02-12 | QIH |
| SubtleSYNTH (1.x) | 2024-07-11 | QIH |
Sources linked on each entry. Coverage note: this lists clearances under tracked AI-associated codes only — the company may hold other clearances outside them. Work for Subtle Medical, Inc.? The disclosure rows on your entries update free on submission of public links — start here.
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