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510(k) Data Aggregation
K Number
K240058Device Name
AEYE-DS
Manufacturer
Date Cleared
2024-04-23
(106 days)
Product Code
Regulation Number
886.1100Why did this record match?
Product Code :
PIB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The AEYE-DS is indicated for use by health care providers to automatically detect more than mild diabetic retinopathy (mtmDR) in adults diagnosed with diabetes who have not been previously diagnosed with diabetic retinopathy. The AEYE-DS is indicated for use with the Topcon NW400 camera and the Optomed Aurora camera.
Device Description
AEYE-DS is a retinal diagnostic software device that incorporates an algorithm to evaluate retinal images for diagnostic screening to identify retinal diseases or conditions. Specifically, the AEYE-DS is designed to perform diagnostic screening for the condition of more-than-mild diabetic retinopathy (mtmDR).
The AEYE-DS is comprised of 5 software components: (1) Client; (2) Service; (3) Analytics; (4) Reporting and Archiving; and (5) System Security.
The AEYE-DS device is based on the principle of operation, whereby a fundus camera is used to obtain retinal images. The fundus camera is attached to a computer, where the Client module/software is installed. The Client module/software guides the user to acquire the images and enables the user to interact with the server-based analysis software over a secure internet connection. Using the Client module/software, users identify the fundus images per eye to be dispatched to the Service module/software. The Service module/software is installed on a server hosted at a secure datacenter, receives the fundus images and transfers them to the Analytics module/software. The Analytics module/software, which runs alongside the Service module/software, processes the fundus images and returns information on the image quality and the presence or absence of mtmDR to the Service module/software. The Service module/software then returns the results to the Client module/software.
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K Number
K223357Device Name
EyeArt v2.2.0
Manufacturer
Date Cleared
2023-06-16
(226 days)
Product Code
Regulation Number
886.1100Why did this record match?
Product Code :
PIB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
EyeArt is indicated for use by healthcare providers to automatically detect more than mild diabetic retinopathy and visionthreatening diabetic retinopathy (severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy and/or diabetic macular edema) in eyes of adults diabetes who have not been previously diagnosed with diabetic retinopathy. EyeArt is indicated for use with Canon CR-2 Plus AF, and Topcon NW400 caneras.
Device Description
EyeArt is a software as a medical device that consists of three components - Client, Server, and Analysis Computation Engine. A retinal fundus camera, used to capture retinal fundus images of the patient, is connected to a computer where the EyeArt Client software is installed. The EyeArt Client software provides a graphical user interface (GUI) that allows the EyeArt operator to transfer the appropriate fundus images to and receive results from the remote EyeArt Analysis Computation Engine through the EyeArt Server. The EyeArt Analysis Computation Engine is installed on remote computer(s) in a secure data center and uses artificial intelligence algorithms to analyze the fundus images and return results. EyeArt is intended to be used with retinal fundus images of resolution 1.69 megapixels or higher captured using one of the indicated retinal fundus cameras (Canon CR-2 AF, Canon CR-2 Plus AF, and Topcon NW400) with 45 degrees field of view. EyeArt is specified for use with two retinal fundus images per eye: optic nerve head (ONH) centered and macula centered. For each patient eye, the EyeArt results separately indicate whether "more than mild diabetic retinopathy (mtmDR)" and "vision-threatening diabetic retinopathy (vtDR)" are detected.
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K Number
K221183Device Name
AEYE-DS
Manufacturer
Date Cleared
2022-11-10
(199 days)
Product Code
Regulation Number
886.1100Why did this record match?
Product Code :
PIB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The AEYE-DS device is indicated for use by health care providers to automatically detect more than mild diabetic retinopathy (mtmDR) in adults diagnosed with diabetes who have not been previously diagnosed with diabetic retinopathy. The AEYE-DS is indicated for use with the Topcon NW400.
Device Description
AEYE-DS is a retinal diagnostic software device that incorporates an algorithm to evaluate ophthalmic images for diagnostic screening to identify retinal diseases or conditions. Specifically, the AEYE-DS is designed to perform diagnostic screening for the condition of more-than-mild diabetic retinopathy (mtmDR).
The AEYE-DS is comprised of 5 software components: (1) Client; (2) Service; (3) Analytics; (4) Reporting and Archiving; and (5) System Security.
The AEYE-DS device is based on the main technological principle of Artificial Intelligence (AI) software as a medical device. The software as a medical device uses artificial intelligence technology to analyze specific disease features from fundus retinal images for diagnostic screening of diabetic retinopathy.
The AEYE-DS device is based on the principle of operation, whereby a fundus camera is used to obtain retinal images. The fundus camera is attached to a computer, where the Client module/software is installed. The Client module/software guides the user to acquire the images and enables the user to interact with the server-based analysis software over a secure internet connection. Using the Client module/software, users identify the fundus images per eye to be dispatched to the Service module/software. The Service module/software is installed on a server hosted at a secure datacenter, receives the fundus images and transfers them to the Analytics module/software. The Analytics module/software, which runs alongside the Service module/software, processes the fundus images and returns information on the image quality and the presence or absence of mtmDR to the Service module/software. The Service module/software then returns the results to the Client module/software.
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K Number
K213037Device Name
IDx-DR v2.3
Manufacturer
Date Cleared
2022-06-17
(269 days)
Product Code
Regulation Number
886.1100Why did this record match?
Product Code :
PIB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
IDx-DR is indicated for use by healthcare providers to automatically detect more than mild diabetic retimopathy (mtmDR) in adults diagnosed with diabetes who have not been previously diagnosed with diabetic retinopathy. IDx-DR is indicated for use with the Topcon NW400.
Device Description
The IDx-DR device is an autonomous, artificial intelligence (AI)-based system for the automated detection of more than mild diabetic retinopathy (mtmDR). It consists of several component parts: IDx-DR Analysis, IDx-DR Client, and IDx-DR Service. The IDx-DR Analysis software analyzes patient images and determines exam quality and the presence/absence of mtmDR. The IDx-DR Client is a software application running on a computer connected to the fundus camera, allowing users to transfer images and receive results. The IDx-DR Service comprises a general exam analysis service delivery software package with a webserver front-end, database, and logging system, and is responsible for device cybersecurity. The system workflow involves image acquisition using the Topcon NW400, transfer to IDx-DR Service, analysis by IDx-DR Analysis System, and display of results on the IDx-DR Client.
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K Number
K203629Device Name
IDx-DR
Manufacturer
Date Cleared
2021-06-10
(181 days)
Product Code
Regulation Number
886.1100Why did this record match?
Product Code :
PIB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
IDx-DR is indicated for use by healthcare providers to automatically detect more than mild diabetic retinopathy in adults diagnosed with diabetes who have not been previously diagnosed with diabetic retinopathy. IDx-DR is indicated for use with the Topcon NW400.
Device Description
The IDx-DR device consists of several component parts. A camera is attached to a computer, where IDx-DR client is installed. Guided by the Client, users acquire two fundus images per eye to be dispatched to IDx-Service. IDx-Service is installed on a server hosted at a secure datacenter. From IDx-Service, images are transferred to IDx-DR Analysis. No information other than the fundus images is required to perform the analysis. IDx-DR Analysis, which runs on dedicated servers hosted in the same secure datacenter as IDx-Service, processes the fundus images and returns information on the exam quality and the presence or absence of mtmDR to IDx-Service. IDx-Service then transports the results to the IDx-DR Client that displays them to the user.
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K Number
K200667Device Name
EyeArt
Manufacturer
Date Cleared
2020-08-03
(143 days)
Product Code
Regulation Number
886.1100Why did this record match?
Product Code :
PIB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
EyeArt is indicated for use by healthcare providers to automatically detect more than mild diabetic retinopathy and visionthreatening diabetic retinopathy (severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy and/or diabetic macular edema) in eyes of adults diagnosed with diabetes who have not been previously diagnosed with more than mild diabetic retinopathy. EyeArt is indicated for use with Canon CR-2 Plus AF cameras in both primary care and eye care settings.
Device Description
EyeArt is a software as a medical device that consists of several components - Client, Server, and Analysis Computation Engine. A retinal fundus camera, used to capture retinal fundus images of the patient, is connected to a computer where the EyeArt Client software is installed. The EyeArt Client software provides a graphical user interface (GUI) that allows the EyeArt operator to transfer the appropriate fundus images to and receive results from the remote EyeArt Analysis Computation Engine through the EyeArt Server. The EyeArt Analysis Computation Engine is installed on remote computer(s) in a secure data center and uses artificial intelligence algorithms to analyze the fundus images and return results. EyeArt is intended to be used with color fundus images of resolution 1.69 megapixels or higher captured using one of the indicated color fundus cameras (Canon CR-2 AF and Canon CR-2 Plus AF) with 45 degrees field of view. EyeArt is specified for use with two color fundus images per eye: optic nerve head (ONH) centered and macula centered.
For each patient eye, the EyeArt results separately indicate whether more than mild diabetic retinopathy (mtmDR) and vision-threatening diabetic retinopathy (vtDR) are detected. More than mild diabetic retinopathy is defined as the presence of moderate non-proliferative diabetic retinopathy or worse on the International Clinical Diabetic Retinopathy (ICDR) severity scale and/or the presence of diabetic macular edema. Vision-threatening diabetic retinopathy is defined as the presence of severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy on the ICDR severity scale and/or the presence of diabetic macular edema.
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K Number
DEN180001Device Name
IDx-DR
Manufacturer
Date Cleared
2018-04-11
(89 days)
Product Code
Regulation Number
886.1100Why did this record match?
Product Code :
PIB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
IDx-DR is indicated for use by health care providers to automatically detect more than mild diabetic retinopathy (mtmDR) in adults diagnosed with diabetes who have not been previously diagnosed with diabetic retinopathy. IDx-DR is indicated for use with the Topcon NW400.
Device Description
The IDx-DR consists of several components. A fundus camera is attached to a computer, where the IDx-DR Client is installed. The Client allows the user to interact with the server-based analysis software over a secure internet connection. Using the Client, users identify two fundus images per eye to be dispatched to IDx-Service is installed on a server hosted at a secure datacenter. IDx-DR Analysis, which runs inside IDx-Service, processes the fundus images and returns information on the image quality and the presence or absence of mtmDR to IDx-Service. IDx- Service then returns the results to the IDx-DR Client.
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