AccessGUDID - DEVICE: Philips IntelliSite Pathology Solution (00884838121263)

GUDID

Device Identifier (DI) Information

Brand Name: Philips IntelliSite Pathology Solution
Version or Model: 5.x IVDR
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 760042
Company Name: Philips Medical Systems Nederland B.V.

Primary DI Number: 00884838121263
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 413819707 *Terms of Use

Device Description: Whole Slide Imaging System. The device is an automated digital slide creation, viewing and management system.

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):	Yes
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 [?]
K233204	000
K242848	000
K243871	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2e559c27-38d4-4c32-9664-2c972fddbbb4
Public Version Date: March 14, 2025
Public Version Number: 2
DI Record Publish Date: February 24, 2025