Sectra Digital Pathology Module

GUDID 07350092810425

For In Vitro Diagnostic Use Sectra Digital Pathology Module device is a software intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis. Sectra Digital Pathology Module is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Sectra Digital Pathology Module. Sectra Digital Pathology Module is intended for use with Leica's Aperio AT2 DX scanner and Dell MR2416 monitor.

Sectra AB

Pathology information system Pathology information system Pathology information system Pathology information system Pathology information system Pathology information system Pathology information system Pathology information system Pathology information system Pathology information system Pathology information system Pathology information system Pathology information system Pathology information system Pathology information system Pathology information system

• Primary Device ID: 07350092810425
• NIH Device Record Key: 439e9b56-f174-43fd-8b2e-971ff152a2f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sectra Digital Pathology Module
• Version Model Number: 3.2
• Company DUNS: 354117848
• Company Name: Sectra AB
• 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: false
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350092810425 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193054

FDA Product Code

• QKQ: Digital Pathology Image Viewing And Management Software

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: 2022-10-25
• Device Publish Date: 2022-10-17

On-Brand Devices [Sectra Digital Pathology Module]

• 07350092810197: For In Vitro Diagnostic Use Sectra Digital Pathology Module device is a software intended for vi
• 07350092810289: For In Vitro Diagnostic Use Sectra Digital Pathology Module device is a software intended for vi
• 07350092810333: For In Vitro Diagnostic Use Sectra Digital Pathology Module device is a software intended for vi
• 07350092810388: For In Vitro Diagnostic Use Sectra Digital Pathology Module device is a software intended for vi
• 07350092810425: For In Vitro Diagnostic Use Sectra Digital Pathology Module device is a software intended for vi
• 07350092810456: For In Vitro Diagnostic Use Sectra Digital Pathology Module device is a software intended for vi
• 07350092810487: For In Vitro Diagnostic Use Sectra Digital Pathology Module device is a software intended for vi