RETINAVUE NETWORK SOFTWARE VERSION 3.X

RETINAVUE NETWORK SOFTWARE VERSION 3.X
Welch Allyn, Inc. - 901108

A software program intended to analyse images of the retina to provide interpretive results for clinical decision support relating to retinal diseases (e.g., diabetic retinopathy, choroidal neovascularization). It utilizes specific algorithms and/or artificial intelligence (AI) and deep learning techniques to assess and perform interpretation of diagnostic images acquired by retinal imaging devices (e.g., fundus camera, retinal optical coherence tomography system, ophthalmoscope) for early diagnosis and management of patients at risk.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: NFJ

Device Name: System, Image Management, Ophthalmic

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: OP

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 892.2050

Third Party Flag: Y

Medical Specialty: RA

Device Id: 00732094223910

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A