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FDA-cleared K242334

Ezra Flash

Ezra AI, Inc.

Authorized purpose: Ezra Flash enhances non-contrast MRI by reducing noise on supported 1.5T and 3T Siemens or GE systems for adults, including head sagittal T1 and axial T2 or FLAIR, abdomen axial or coronal T2, and pelvis sagittal, axial, or coronal T2 studies.

Modality
MRI
Anatomy
Head, abdomen, and pelvis
Decision
2025-01-02
FDA-cleared K230264

Ezra Flash

Ezra AI, Inc.

Authorized purpose: Ezra Flash is MR image-processing software used to reduce image noise in non-contrast MRI examinations acquired on 3-Tesla Siemens and GE scanners for sagittal T1, axial T2, and axial FLAIR sequences of the head in patients older than 18 years.

Modality
MRI
Anatomy
Head
Decision
2023-04-13
FDA-cleared K192969

Ezra Plexo Software

Ezra AI Inc.

Authorized purpose: Ezra Plexo Software is a medical diagnostic application for viewing, manipulation, three-dimensional visualization, and comparison of MR medical images. It supports an oncologic workflow by helping the user confirm the absence or presence of lesions, including evaluation, quantification, and documentation; the clinician retains responsibility for diagnosis and the software complements standard review of separate unregistered images.

Modality
MRI
Anatomy
MR images and lesions in oncologic imaging
Decision
2020-07-10