Compatibility expansion PCCPs
16 of the 143 FDA-authorized PCCPs are Compatibility expansion plans, 9 of them AI/SaMD. Here is the full list, newest first.
- K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS2026-05-21AI hardwareCompatibility expansion
- K252284eMurmur Heart AICsd Labs2025-12-19AI/SaMDCompatibility expansion
- K252762HALO AP DxIndica Labs, LLC2025-11-25Non-AICompatibility expansion
- K252357Glucose2Abbott Ireland2025-10-24Non-AICompatibility expansion
- K252072Francisella tularensis Real-time PCR assayCenters for Disease Control and Prevention2025-09-30Non-AICompatibility expansion
- K251217SmartGuard technology; Predictive Low Glucose technologyMedtronic Minimed, Inc.2025-08-29AI/SaMDCompatibility expansion
- DEN240068ArteraAI ProstateArtera, Inc.2025-07-31AI/SaMDCompatibility expansion
- K243679MammoScreen® (4)Therapixel2025-07-03AI/SaMDCompatibility expansion
- K250524Mendaera Guidance SystemMendaera, Inc.2025-07-02Non-AICompatibility expansion
- K251032MiniMed 780G insulin pumpMedtronic Minimed, Inc.2025-07-01Non-AICompatibility expansion
- K243391AISight DxPathAI, Inc.2025-06-26Non-AICompatibility expansion
- K250798Control-IQ+ technologyTandem Diabetes Care, Inc.2025-05-21AI/SaMDCompatibility expansion
- K242807HeartFocus (V.1.1.1)Deski2025-04-04AI/SaMDCompatibility expansion
- K241350Clarify DLGe Medical Systems Israel, Functional Imaging2025-01-03AI/SaMDCompatibility expansion
- K240417ProFound Detection (V4.0)Icad, Inc.2024-11-08AI/SaMDCompatibility expansion
- K241561MammoScreen BDTherapixel2024-10-02AI/SaMDCompatibility expansion
Other PCCP types
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We read the Compatibility expansion PCCPs in this list, 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.