FDA PCCP Tracker
Every FDA-authorized Predetermined Change Control Plan, updated monthly from public FDA records.
37
PCCP authorizations
13
AI/SaMD PCCPs
23
Added in the last 90 days
Last updated: 2026-06-12
Authorizations over time
PCCP authorizations per quarter
All PCCP authorizations
Showing 13 AI/SaMD PCCPs · 24 other PCCPs hidden —
MSK Go
FDA ↗Smart Alfa Teknoloji San. Ve Tic. A.S.
PCCP permits adding compatible ultrasound systems while keeping AI/ML algorithms, architecture, training data, and intended use fixed.
2026-05-21 · 510(k) · Radiology
BAC
FDA ↗DeepHealth, Inc.
PCCP permits adding compatible mammography systems and updating AI models; performance acceptance criteria and indications for use remain fixed.
2026-05-21 · 510(k) · Radiology
SubtleHD-PET (1.x)
FDA ↗Subtle Medical, Inc.
PCCP permits adding denoising mix factor levels and expanding training data to cover more scanners, ages, anatomies, detector types, and radiotracers.
2026-05-14 · 510(k) · Radiology
ArteraAI Breast
FDA ↗Artera, Inc.
Software-only AI/ML SaMD (multimodal). Analyzes H&E whole-slide images + clinical variables (age, tumor size, nodal status) to output 5/10-yr distant-metastasis risk and ArteraAI risk score for HR+/HER2-, N0/N1 early breast cancer. PCCP authorizes iterative model updates without a new 510(k); IFU implies addition of validated interoperable scanners/file formats. Artera also holds ArteraAI Prostate (de novo, PCCP). Note: upload contains only decision letter + IFU — full 510(k) summary / PCCP modification protocol not captured.
2026-05-04 · 510(k) · Pathology
syngo Dynamics (VA41F)
FDA ↗Siemens Healthcare GmbH
PCCP permits retraining, algorithm optimization, and input/output expansion for three AI functions; test methods and acceptance criteria remain fixed.
2026-04-10 · 510(k) · Radiology
ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)
FDA ↗Anumana, Inc.
PCCP permits performance improvement updates with new training data and expansion of compatible ECG devices, while keeping architecture and acceptance criteria fixed.
2026-04-07 · 510(k) · Cardiovascular
ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)
FDA ↗Anumana, Inc.
PCCP permits periodic model performance updates via multi-center retrospective validation with at least 10% new data; intended use and architecture remain fixed.
2026-03-28 · 510(k) · Cardiovascular
Contour ProtégéAI+
FDA ↗Mim Software, Inc.
PCCP permits adding new CT/MR/CBCT models and retraining on cleared architectures with improved data; core architecture and validation framework remain fixed.
2026-03-27 · 510(k) · Radiology
Tyto Insights for Eardrum Bulging Detection
FDA ↗Tyto Care , Ltd.
PCCP permits retraining, architecture/preprocessing changes, and adding new Tyto Otoscope models; third-party otoscopes and input signal type remain fixed.
2026-03-17 · De Novo · Ear, Nose, Throat
AI Platform 2.2 (AIP002)
FDA ↗Exo Imaging
Permits AI model architecture changes and training-data augmentation, validated by non-inferiority vs. prior version; inputs/outputs fixed, models locked before release, retraining manual.
2026-02-24 · 510(k) · Radiology
Seg Pro V3 (RT-300)⚑
FDA ↗Ever Fortune.Ai, Co., Ltd.
PCCP permits model weight updates via retraining on real-world data; architecture, inference pipeline, and pre/post-processing remain fixed.
2026-01-28 · 510(k) · Radiology
qXR-Detect
FDA ↗Qure.Ai Technologies
PCCP permits data-driven retraining and CNN-to-ViT encoder replacement; indications, outputs, and workflow remain fixed.
2026-01-16 · 510(k) · Radiology
Corvair Monza
FDA ↗AliveCor, Inc.
PCCP permits retraining model weights with additional data; architecture, input signal type, output type, and intended use remain fixed.
2026-01-09 · 510(k) · Cardiovascular
New PCCP authorizations land here first.
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Methodology
This tracker is built from the openFDA 510(k) API, FDA decision letters, and the 510(k) summaries and De Novo decision summaries posted on accessdata.fda.gov. PCCP status is not a structured field in any FDA database, so authorizations are identified by reading the underlying documents for Predetermined Change Control Plan language.
The category (AI/SaMD, AI hardware, non-AI) and PCCP type assigned to each device are manually reviewed classifications based on what the public documents describe, not FDA designations.
Known gaps: 510(k)s filed with a statement instead of a summary have no public document to read; PMA supplements are not currently covered; and very recent authorizations may be missing until FDA posts their documents.
Maintained by Sentir Health — post-market monitoring infrastructure for FDA-cleared AI.
This tracker is for informational purposes only. It is not regulatory or legal advice, and it is not affiliated with or endorsed by the U.S. Food and Drug Administration.