AccessGUDID - DEVICE: Aperio GT 450 DX (US) Scanner (00815477020525)

GUDID

Device Identifier (DI) Information

Brand Name: Aperio GT 450 DX (US) Scanner
Version or Model: 23GT450DXUS
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: LEICA BIOSYSTEMS IMAGING, INC

Primary DI Number: 00815477020525
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 063440460 *Terms of Use

Device Description: Aperio GT 450 DX Digital Pathology Scanner is a continuous slide loading while scanning, automated image quality check and Leica universal rack compatibility. Includes 15 Leica universal racks. The Aperio GT 450 DX scanner is an automated digital slide creation instrument. The Aperio GT450 DX scanner is intended for in vitro diagnostic use as an aid to the pathologist to create digital images of surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
62575	Microscope slide digital imaging scanner IVD	A mains electricity (AC-powered) device designed to be used in a histopathology laboratory to scan clinical specimens on microscope slides, at a microscopic level, to produce images in a digital format. Also known as a whole slide scanner or digital pathology slide scanning system, it is a bench-top unit with slide tray slots, high-resolution cameras, a user interface, and integrated software for image creation, viewing, and management to aid the pathologist to review and interpret slide images.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PSY	Whole Slide Imaging System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K232202	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify:

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify:

Device Record Status

Public Device Record Key: a9a6217c-ef4c-4359-8f76-4bc77fff1c55
Public Version Date: June 27, 2024
Public Version Number: 2
DI Record Publish Date: May 31, 2024