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FDA-cleared K222036

MPXA-2000

Medipixel, Inc.

Authorized purpose: Quantified results from X-ray angiographic images of the coronary arteries to support clinical decisions about diagnosis or treatment evaluation in adult patients with coronary artery disease; results are not the sole basis for diagnosis.

Modality
X-ray/Radiography
Anatomy
Coronary arteries and cardiovascular anatomy
Decision
2023-03-22