Sectra Digital Pathology Module - For In Vitro Diagnostic UseSectra Digital - Sectra AB

Duns Number:354117848

Device Description: For In Vitro Diagnostic UseSectra Digital Pathology Module device is a software intended f For In Vitro Diagnostic UseSectra 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.

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More Product Details

Catalog Number

-

Brand Name

Sectra Digital Pathology Module

Version/Model Number

2.4

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K193054

Product Code Details

Product Code

QKQ

Product Code Name

Digital Pathology Image Viewing And Management Software

Device Record Status

Public Device Record Key

8f5f4a3b-d8b0-49d4-8f4c-81b453e4690e

Public Version Date

October 19, 2020

Public Version Number

1

DI Record Publish Date

October 09, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SECTRA AB" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 33