AI100 with Shonit

JSON twin: https://www.healthaidb.com/software/ai100-with-shonit.json

Company Name

SigTuple Technologies

Product URL

https://www.sigtuple.com/ai100-with-shonit

Company URL

https://www.sigtuple.com

Categories

• clinical Care
• diagnostic Support
• laboratory Automation
• clinical Decision Support
• medical Device
• Clinical
• Diagnostic
• Ai In Healthcare
• Medical Devices

Summary

AI100 with Shonit is an AI-powered device that automates the digitization and analysis of peripheral blood smear samples, enhancing diagnostic efficiency and enabling remote pathology reviews.

Description

AI100 with Shonit is an in-vitro diagnostic device developed by SigTuple Technologies, designed to automate the manual microscopy process in diagnostic laboratories. It utilizes robotics and AI to digitize peripheral blood smear samples, allowing pathologists to remotely review and analyze blood cell morphology. The device classifies cells into over 30 different types, improving diagnostic accuracy and efficiency. In October 2023, AI100 with Shonit received U.S. FDA 510(k) clearance, marking it as the first integrated hardware and AI medical device from India to obtain this approval. This clearance signifies a significant advancement in AI-assisted digital pathology, facilitating the remote review of blood samples and enhancing the efficiency of pathologists. The device addresses challenges such as the need for skilled pathologists on-site and the variability in sample quality, making it a robust solution for widespread adoption in clinical laboratories. SigTuple's AI100 with Shonit represents a transformative approach to pathology, leveraging AI and robotics to automate the microscopic review of blood samples, thereby improving patient outcomes and streamlining laboratory workflows.

Api Available

unknown

Certifications

• FDA 510(k) clearance
• CE certification

Company Founding

2015

Company Offices

• India
• United States

Compliance

• FDA 510(k) clearance
• CE certification

Customers

Data Residency

US/EU regions

Data Standards

• FDA 510(k) clearance for AI-powered digital pathology

Deployment Model

• SaaS
• on_prem
• hybrid

Features

• Automated microscopic review of blood and urine samples
• AI-assisted digital pathology with remote review capabilities
• 7-part differential count with NRBC flagging
• Smear agnostic and stain agnostic system
• High-resolution image capture at 40x magnification
• Automated sample preparation with quality check feedback
• Cloud-based reporting and tele-reporting capabilities
• High-throughput capability with scanning of 20 blood slides and 12 urine slides per hour

Id

SW0313

Integration Partners

Integrations

• HORIBA hematology analyzers
• LIMS integration for CBC reports

Languages Supported

• English
• Hindi
• Kannada
• Other Indian Languages

Last Updated

2025-10-11

License

Commercial

Market Segment

• Enterprise
• SMB

Optional Modules

• Shrava – AI Application for Urine Analysis

Os Platforms

• Web

Pricing Details

Contact vendor for pricing information.

Pricing Model

Enterprise Quote

Privacy Features

• BAA available
• Consent management
• Anonymization
• Data minimization

Product Code

SW0313

Product Name

AI100 with Shonit

Ratings

Regions Available

• India
• United States
• Global

Related Urls

• https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices

Release Year

Security Features

• Encryption
• RBAC
• Audit logs
• 2FA

Specialties

• Hematology
• Oncology
• Infectious Diseases
• Hematological Disorders
• Anemia
• Allergies

Support Channels

System Requirements

Windows, macOS, Linux

Target Users

• Pathologists
• Clinical Laboratories
• Healthcare Providers

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

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  "product_name": "AI100 with Shonit",
  "company_name": "SigTuple Technologies",
  "product_url": "https://www.sigtuple.com/ai100-with-shonit",
  "company_url": "https://www.sigtuple.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0313",
  "summary": "AI100 with Shonit is an AI-powered device that automates the digitization and analysis of peripheral blood smear samples, enhancing diagnostic efficiency and enabling remote pathology reviews.",
  "description": "AI100 with Shonit is an in-vitro diagnostic device developed by SigTuple Technologies, designed to automate the manual microscopy process in diagnostic laboratories. It utilizes robotics and AI to digitize peripheral blood smear samples, allowing pathologists to remotely review and analyze blood cell morphology. The device classifies cells into over 30 different types, improving diagnostic accuracy and efficiency. In October 2023, AI100 with Shonit received U.S. FDA 510(k) clearance, marking it as the first integrated hardware and AI medical device from India to obtain this approval. This clearance signifies a significant advancement in AI-assisted digital pathology, facilitating the remote review of blood samples and enhancing the efficiency of pathologists. The device addresses challenges such as the need for skilled pathologists on-site and the variability in sample quality, making it a robust solution for widespread adoption in clinical laboratories. SigTuple's AI100 with Shonit represents a transformative approach to pathology, leveraging AI and robotics to automate the microscopic review of blood samples, thereby improving patient outcomes and streamlining laboratory workflows.",
  "categories": [
    "clinical Care",
    "diagnostic Support",
    "laboratory Automation",
    "clinical Decision Support",
    "medical Device",
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    "Diagnostic",
    "Laboratory Automation",
    "Ai In Healthcare",
    "Medical Devices"
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  "market_segment": [
    "Enterprise",
    "SMB"
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  "target_users": [
    "Pathologists",
    "Clinical Laboratories",
    "Healthcare Providers"
  ],
  "specialties": [
    "Hematology",
    "Oncology",
    "Infectious Diseases",
    "Hematological Disorders",
    "Anemia",
    "Allergies"
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  "regions_available": [
    "India",
    "United States",
    "Global"
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  "languages_supported": [
    "English",
    "Hindi",
    "Kannada",
    "Other Indian Languages"
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  "pricing_model": "Enterprise Quote",
  "pricing_details": "Contact vendor for pricing information.",
  "license": "Commercial",
  "company_offices": [
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    "United States"
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  "company_founding": "2015",
  "deployment_model": [
    "SaaS",
    "on_prem",
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  "os_platforms": [
    "Web"
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  "features": [
    "Automated microscopic review of blood and urine samples",
    "AI-assisted digital pathology with remote review capabilities",
    "7-part differential count with NRBC flagging",
    "Smear agnostic and stain agnostic system",
    "High-resolution image capture at 40x magnification",
    "Automated sample preparation with quality check feedback",
    "Cloud-based reporting and tele-reporting capabilities",
    "High-throughput capability with scanning of 20 blood slides and 12 urine slides per hour"
  ],
  "optional_modules": [
    "Shrava – AI Application for Urine Analysis"
  ],
  "integrations": [
    "HORIBA hematology analyzers",
    "LIMS integration for CBC reports"
  ],
  "data_standards": [
    "FDA 510(k) clearance for AI-powered digital pathology"
  ],
  "api_available": "unknown",
  "system_requirements": "Windows, macOS, Linux",
  "compliance": [
    "FDA 510(k) clearance",
    "CE certification"
  ],
  "certifications": [
    "FDA 510(k) clearance",
    "CE certification"
  ],
  "security_features": [
    "Encryption",
    "RBAC",
    "Audit logs",
    "2FA"
  ],
  "privacy_features": [
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    "Anonymization",
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  "data_residency": "US/EU regions",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0313",
  "slug": "ai100-with-shonit",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/ai100-with-shonit.json"
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}