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510(k) Data Aggregation
K Number
K242334Device Name
Ezra Flash
Manufacturer
Date Cleared
2025-01-02
(148 days)
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Ezra AI, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Ezra Flash is an image processing software used for image enhancement of MR images. It can be used to reduce image noise in images acquired as part of non-contrast MRI exams on 1.5-Tesla and 3-Tesla Siemens and GE scanners for patients > 18 years of age:
- · Sagittal T1, Axial T2 and Axial Flair sequences within the head region
- · Axial T2, Coronal T2 within the Abdomen region.
- · Sagittal T2, Axial T2, Coronal T2 within the Pelvis region
Device Description
Ezra Flash is a Software as a Medical Device (SaMD) consisting of a software algorithm that enhances images of the head, abdomen, and pelvis regions taken by MRI scanners. As it only processes images for the end user, the device has no interface. It is intended to be used by radiologists in an imaging center, clinic, or hospital. The software can be used with MR images acquired as part of MRI exams on 1.5-Tesla and 3-Tesla scanners from Siemens and GE.
The outputs are images with enhanced image quality. Both the original non-enhanced studies and the Ezra Flash-enhanced studies are available to the end user.
Ezra Flash receives DICOM-compliant non-contrast MR image inputs acquired on 1.5-Tesla and 3-Tesla scanners within the head, abdomen and pelvis regions. The software uses a convolutional neural network-based algorithm to improve image quality by reducing noise. The device outputs a DICOM-compliant copy of the images with improved image quality.
Ezra Flash is tested for performance on Sagittal T1, Axial T2, Axial T2 Flair images of the head, Coronal T2, Axial T2 images of the abdomen, Sagittal T2, Axial T2, and Coronal T2 images of the pelvis.
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K Number
K230264Device Name
Ezra Flash
Manufacturer
Date Cleared
2023-04-13
(72 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Ezra AI, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Ezra Flash is an image processing software used for image enhancement of MR images. It can be used to reduce image noise in images acquired as part of non-contrast MRI exams on 3-Tesla Siemens for Sagittal T1, Axial T2 and Axial Flair sequences within the head region for patients > 18 years of age.
Device Description
Ezra Flash is a Software as a Medical Device (SaMD) consisting of a software algorithm that enhances images of the head region taken by MRI scanners. As it only processes images for the end user, the device has no interface. It is intended to be used by radiologists in an imaging center, clinic, or hospital. The software can be used with MR images acquired as part of MRI exams on 3-Tesla Siemens and GE scanners. The outputs are images with enhanced image quality. Both the original non-enhanced studies and the Ezra Flash-enhanced studies are available to the end user. Ezra Flash receives DICOM-compliant non-contrast MR image inputs acquired on 3-Tesla scanners for Sagittal T1, Axial T2 and Axial Flair sequences within the head region. The software uses a convolutional neural network-based algorithm to improve image quality by reducing noise. The device outputs a DICOM-compliant copy of the images with improved image quality.
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