Medical AI Evaluation

We aggregate 141 FDA approved AI devices and report how each device was evaluated.

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Device Database

approval_number
device_name
classification_product_code
date_received
decision_date
indications_for_use
body_area
modality
predicate_numbers
sample_size
num_sites
inc_exc_criteria
has_demographics
is_prospective
subtype_analysis
significance
severity
risk_level
keywords
summary_link

Visualizations

Device Summaries

Device Name:
Approval Number:
Decision Date:
Indications for Use:
Body Area:
Modality:
Sample Size:
Number of Sites:
Risk Level:
Has Inclusion/Exclusion Criteria?:
Has Demographic Data?:
Has a Prospective Study?:
Has Subtype Analysis?:

Methodology Notes

Evaluation feature details:
Version changes: