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FDA-cleared K202718

Qmenta Care Platform Family

Mint Labs, Inc., d/b/a. QMENTA

Authorized purpose: Qmenta Care Platform Family is the exact FDA-cleared medical-image software submission identified by K202718; use is limited to the modality, anatomy, inputs, outputs, and clinical workflow stated in its FDA decision material, with no broader modality or performance claim promoted here.

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Patient-specific anatomy represented in imported medical images
Decision
2021-06-16