Aperio AT2 DX Scanner for Primary Diagnosis. Includes installation and one day of training. One year warranty. Must be used in conjunction with Aperio DX Viewing Station for Primary Diagnosis.

Aperio AT2 DX Scanner for Primary Diagnosis. Includes installation and one day of training. One year warranty. Must be used in conjunction with Aperio DX Viewing Station for Primary Diagnosis.
Aperio AT2 DX Scanner - 23AT2DX

An assembly of mains electricity (AC-powered) devices consisting of two or more analysers of different analytic modalities [e.g., immunoassay and photometric (clinical chemistry)] intended to be used for the qualitative and/or quantitative determination of chemical and/or biological markers (e.g., drug, hormone, microbial toxin, electrolytes) in a clinical specimen. The assembly may also include a sample preparation instrument, reagent management instrument, data processing and/or data display software. The device operates with minimal technician involvement and complete automation of all procedural steps.

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: PSY

Device Name: Whole Slide Imaging System

Device Class: 2

Physical State: The whole slide imaging system consists of an image management system, a scanner and associated software, and a display monitor. The whole slide imaging system does not include any automated Image Analysis Applications that would constitute computer aided detection or diagnosis.

Definition: The whole slide imaging system is an automated digital slide creation, viewing, and management system intended as an aid to the pathologist to review and interpret digital images of surgical pathology slides prepared from formalin-fixed, paraffin-embedded (FFPE) tissue. The system generates digital images that would otherwise be appropriate for manual visualization by conventional brightfield microscopy. The whole slide imaging system is not intended for use with slides prepared from frozen tissue, cytology, and non-FFPE hematopathology specimens (e.g., peripheral blood smear).

Submission Type ID: 1

Review Panel: PA

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: The whole slide imaging system consists of an image management system, a scanner and associated software, and a display monitor. Pathologists view and interpret scanned digital images, employing appropriate processes to ensure the validity of the interpretation. The system may include web-based applications.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Surgical pathology slides prepared from formalin-fixed, paraffin-embedded (FFPE) tissue Not for use with slides prepared from frozen tissue, cytology, and non-FFPE hematopathology specimens.

Regulation Number: 864.3700

Third Party Flag: N

Medical Specialty: PA

Device Id: 00815477020259

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