syngo.CT Coronary Cockpit
Siemens Medical Solutions USA, Inc. · K253786
FDA-authorized Predetermined Change Control Plan
- Company
- Siemens Medical Solutions USA, Inc.
- 510(k)/De Novo #
- K253786
- Decision date
- 2026-06-25
- Panel
- Radiology
- Pathway
- 510(k)
- Category
- AI/SaMD
- PCCP type
- Retraining
- Monitoring commitment
- Not stated
What this PCCP covers. Permits model retraining with additional data
Other Radiology PCCPs
- K260714MammoScreen® (5)Therapixel2026-06-26AI/SaMDCompatibility expansion
- K260406Brainomix 360 HyperdensityBrainomix Limited2026-06-12AI/SaMDRetraining
- K260322Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical2026-06-11AI/SaMDRetraining
- 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
Want the monitoring teardown?
We read the PCCP for syngo.CT Coronary Cockpit, 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.