Aperio AT2 DX Scanner

GUDID 00815477020259

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.

LEICA BIOSYSTEMS IMAGING, INC

Multi-modality clinical specimen analysis system IVD

• Primary Device ID: 00815477020259
• NIH Device Record Key: f254dbb2-1408-4001-a4f5-ac020c65b47e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aperio AT2 DX Scanner
• Version Model Number: 23AT2DX
• Company DUNS: 063440460
• Company Name: LEICA BIOSYSTEMS IMAGING, INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(866)4783999
• Email: techservices@LeicaBiosystems.com

Device Dimensions

• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815477020259 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190332

FDA Product Code

• PSY: Whole slide imaging system

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-01-31
• Device Publish Date: 2020-01-23

Devices Manufactured by LEICA BIOSYSTEMS IMAGING, INC

• 00815477020259 - Aperio AT2 DX Scanner: 2020-01-31Aperio 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.
• 00815477020259 - Aperio AT2 DX Scanner: 2020-01-31 Aperio AT2 DX Scanner for Primary Diagnosis. Includes installation and one day of training. One year warranty. Must be used in c
• 00815477020051 - eIHC IVD bundle CS2- 2500: 2018-03-29 Aperio ePathology IVD System CS2, includes; CS2 IVD, eSlide Manager and eIHC 510(k) Cleared Image Analysis Kit 2500
• 00815477020068 - eIHC IVD bundle AT Turbo-2500: 2018-03-29 Aperio ePathology IVD System AT Turbo, includes; AT Turbo IVD, eSlide Manager and eIHC 510(k) Cleared Image Analysis Kit 2500