Reviewed 21 Jul 2026

Completeness Fair (36%)

Full-Field Peripheral Blood Smear Application

Scopio Labs

The Full Field PBS on X100HT is an application designed to provide high resolution digital imaging of the monolayer and feathered edge regions of stained peripheral blood smear (PBS) slides, acquired using Scopio Labs’ digital microscope. The system is intended to assist a qualified operator in performing peripheral blood smear review through dedicated software and hardware. The device enables scanning of all relevant areas of the slide and prepares the corresponding digital information for operator review, while keeping the user in full control throughout the workflow. The system supports evaluation of peripheral blood samples by enabling: White blood cell (WBC) differential, red blood cell (RBC) morphological assessment and Platelet estimation.

Supported by 1 paper

General Information

Product name

Full-Field Peripheral Blood Smear Application

Modality

Cytopathology

Main task

Classification, Detection

Subspeciality

Hematopathology

Organ/Specimen source

Not specified

Disease targeted

Hematologic disorders

Specimen type

Smear(s)

Staining

Romanowsky

Stain subtype

Not specified

Regulatory Information

FDA Certification

Pathway:

510(k) cleared

Class:

Class II

FDA Number:

Verified by Health AI Register

CE-IVD Certification

Pathway:

In Vitro Diagnostic Regulation (IVDR)

Class:

Class B

Verified by Health AI Register

Scanner Brands Certified for Use (CE-IVD)

Scopio Labs

Scanner Models Certified for Use (CE-IVD)

X100HT

Other certifications

Not specified

Technical Specifications

Patient population age

Not specified

Input

Not specified

Input format

Not specified

Output

Not specified

Output format

Not specified

Integration

Not specified

Deployment

Not specified

Trigger for analysis

Not specified

Processing time

Not specified

Population

Not specified

Viewer systems

Not specified

Market Presence

On market since

13-04-2020

AI Platforms

Resellers

Not specified

Countries present

Not specified

Paying clinical customers

Not specified

Research/test users

Not specified

Pricing Information

Pricing model

Not specified

Based on

Not specified

First published: Apr 24, 2026 | Last updated: Jul 21, 2026

Full-Field Peripheral Blood Smear Application - Scopio Labs