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510(k) Data Aggregation
K Number
K223659Device Name
Jazz
Manufacturer
Date Cleared
2023-09-22
(290 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
AI Medical AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Jazz is intended for the labeling, visualization and volumetric quantification of segmentable brain structures from a set of MR images, for patients with a known diagnosis of multiple sclerosis (for the multiple sclerosis pipeline) and/or brain metastasis (for the metastasis pipeline), and the production of a radiological report.
Device Description
Jazz is a Software as a Medical Device (SaMD) consisting of a software intended to be a facilitating tool for the physicians, in the sense of a semi-automatic pipeline for the process of identifying, labeling and quantifying the volume of segmentable brain structures identified on MR images. "Semi-automatic" refers to the possibility given to the physician to correct the segmentation of the software before saving.
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K Number
K211715Device Name
RetinAI Discovery
Manufacturer
Date Cleared
2022-04-28
(329 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
RetinAI Medical AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The RetinAl Discovery is a standalone, browser-based software application intended for use by healthcare professionals to import, store, manage, display, analyze and measure data from ophthalmic diagnostic instruments, including: patient data, clinical images and information, reports and measurements of DICOM-compliant images. The device is also indicated for manual labeling and annotation of retinal OCT scans.
Device Description
The RetinAl Discovery consists of a platform which displays and analyzes images of the eye (e.g. OCT scans and fundus images) along with associated measurements (e.g. layer thickness) generated by the user through Discovery. The platform allows the user to manually segment layers and volumes in the images, it calculates the layer thickness and volume from annotated images and presents the progression of the measurement in graphs. Discovery provides a tool for measuring ocular anatomy and ocular lesion distances. The multiple views in Discovery and the measurements allow the user to assess the eye anatomy and, ultimately, assist the user in making decisions on diagnosis and monitoring of disease progression.
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