AccessGUDID - DEVICE: Concentriq AP-Dx (00860006054519)

GUDID

Device Identifier (DI) Information

Brand Name: Concentriq AP-Dx
Version or Model: 4.5
Commercial Distribution Status: In Commercial Distribution
Catalog Number: US
Company Name: Proscia Inc.

Primary DI Number: 00860006054519
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079846027 *Terms of Use

Device Description: Concentriq AP-Dx is a web-based, software-only device that is intended to aid pathology professionals in viewing, interpretation and management of digital whole slide images (WSI) of scanned surgical pathology slides prepared from formalin-fixed, paraffin-embedded (FFPE) tissue obtained from Hamamatsu NanoZoomer S360MD Slide scanner. It aids the pathologist in the review, interpretation, and management of pathology slide digital images used to generate a primary diagnosis.

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?
43472	Laboratory instrument/analyser application software IVD	An in vitro diagnostic software program intended to be used with an instrument/analyser (e.g., microscope slide digital imaging scanner, immunoassay analyser, real-time PCR machine), or a data management device connected to the instrument/analyser, to: 1) facilitate user-controlled device function [e.g., incubation control]; 2) assist data processing, display, or communication [e.g., image conversion]; and/or 3) produce raw-data-derived qualitative result calculations based on specified criteria [positive or negative assay result]. This software does not use demographic or clinical data to produce a patient score (i.e., it is not interpretive).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QKQ	Digital Pathology Image Viewing And Management Software
PSY	Whole Slide Imaging System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K230839	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: 7fb8b4cc-bb37-4a72-a7f2-33708840f02b
Public Version Date: September 03, 2024
Public Version Number: 1
DI Record Publish Date: August 26, 2024