SubtleHD (1.x)
Subtle Medical, Inc. · K243250
FDA-authorized Predetermined Change Control Plan
- Company
- Subtle Medical, Inc.
- 510(k)/De Novo #
- K243250
- Decision date
- 2025-02-12
- Panel
- Radiology
- Pathway
- 510(k)
- Category
- AI/SaMD
- PCCP type
- I/O expansion
- Monitoring commitment
- Not stated
What this PCCP covers. Permits input/output expansion to compatible devices
Other PCCPs from Subtle Medical, Inc.
Other Radiology PCCPs
- K260234MSK GoSmart Alfa Teknoloji San. Ve Tic. A.S.2026-05-21AI/SaMDI/O expansion
- K254131BACDeepHealth, Inc.2026-05-21AI/SaMDI/O expansion
- K254013SubtleHD-PET (1.x)Subtle Medical, Inc.2026-05-14AI/SaMDRetraining
- K253689syngo Dynamics (VA41F)Siemens Healthcare GmbH2026-04-10AI/SaMDRetraining
- K253270Contour ProtégéAI+Mim Software, Inc.2026-03-27AI/SaMDRetraining
- K253593Clarius Ejection Fraction AIClarius Mobile Health Corp.2026-03-02AI hardwareI/O expansion
Want the monitoring teardown?
We read the PCCP for SubtleHD (1.x), then map the post-market monitoring that its modification protocol requires, including the deployment-period evidence most teams can't reconstruct at modification time. Sentir is the independent system of record that produces it.
Book a callSource: U.S. FDA public records (openFDA 510(k)/De Novo databases and accessdata.fda.gov). PCCP type and category are editorial classifications based on public documents, not official FDA designations.
This page is a factual summary of public FDA records. Sentir Health is not affiliated with or endorsed by the named companies or the U.S. Food and Drug Administration. Spot an error? Request a correction.