Computer to operate the Genius™ Review Station.

Computer to operate the Genius™ Review Station.
DIGITAL DIAGNOSTICS SYSTEM - ASSEMBLY, REVIEW STATION COMPUTER

An in vitro diagnostic software program intended to be used with an instrument/analyser (e.g., microscope slide digital imaging scanner, immunoassay analyser, real-time PCR machine), or a data management device connected to the instrument/analyser, to: 1) facilitate user-controlled device function [e.g., incubation control]; 2) assist data processing, display, or communication [e.g., image conversion]; and/or 3) produce raw-data-derived qualitative result calculations based on specified criteria [positive or negative assay result]. This software does not use demographic or clinical data to produce a patient score (i.e., it is not interpretive).

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: QYV

Device Name: Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm

Device Class: 2

Physical State: System includes a digital imager and slide identification reader. Digital imager’s graphic, menu-driven interface may be accessed through a touch screen or connected computer. Slide images may be stored on a local or cloud server for review on an external computer using a dedicated software application. Includes an AI-based algorithm to identify objects of interest found on a digital image of the slide. System may be limited for use with specific Pap tests.

Definition: The digital cervical cytology slide imaging system with artificial intelligence (AI) algorithm is a prescription in vitro diagnostic device consisting of an automated digital slide creation, viewing, and management system intended to aid in the review of digital images of slides prepared from Pap test specimens and conventional Pap smears by selecting and presenting areas of interest to facilitate interpretation by the reader. The AI software algorithm uses machine learning techniques to provide information to the user about the presence, location, or characteristics of areas of the image with clinical implications. Information from this device is intended to assist the user in rendering a cytology diagnosis.

Submission Type ID: 1

Review Panel: PA

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Digitizes and presents whole slide image and objects of interest on a display monitor from cytology Pap test glass slide images using artificial intelligence (AI) based algorithms to detect and/or characterize cells and other entities of clinical interest/significance.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Cytologic slide preparations of human liquid-based cervical cytology (Pap test) specimens.

Regulation Number: 864.3900

Third Party Flag: N

Medical Specialty: PA

Device Id: 15420045513914

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