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ClariPlatform

FDA UDI

Class I (US FDA UDI)

by ClariPI Inc.

Identity

Trade Name
ClariPlatform FDA UDI
Generic Name
Radiological image interpretive software sharing portal FDA UDI
Device Name
ClariPlatform (Ver. ClariSuite View) is a medical imaging platform that hosts clinical AI solutions and provides user interface in an on-premise environment. The system facilitates the networking, filtering, routing, and optional de-identification of medical image data between imaging systems, allowing users to easily execute AI solutions on-demand or integrate them into their clinical workflow. Additionally the system allows users to interact with the AI analysis results including confirming, rejecting, and selecting other category than provided by AI. While ClariPlatform (Ver.1.0) operates as a cloud-based system, ClariPlatform (Ver. ClariSuite View) is specifically designed for on-premise deployment, ensuring compliance with institutional security policies, regulatory requirements, and data privacy concerns. ClariPlatform (Ver. ClariSuite View) is deployed within anorganization’s internal infrastructure, allowing healthcare providers to maintain full control over medical imaging data while leveraging advanced AI-assisted visualization tools. Clinical AI solutions refer to separate medical device software and are not included within the scope of this system. FDA UDI
Model / Reference
ClariSuite View FDA UDI
Description
ClariPlatform (Ver. ClariSuite View) is a medical imaging platform that hosts clinical AI solutions and provides user interface in an on-premise environment. The system facilitates the networking, filtering, routing, and optional de-identification of medical image data between imaging systems, allowing users to easily execute AI solutions on-demand or integrate them into their clinical workflow. Additionally the system allows users to interact with the AI analysis results including confirming, rejecting, and selecting other category than provided by AI. While ClariPlatform (Ver.1.0) operates as a cloud-based system, ClariPlatform (Ver. ClariSuite View) is specifically designed for on-premise deployment, ensuring compliance with institutional security policies, regulatory requirements, and data privacy concerns. ClariPlatform (Ver. ClariSuite View) is deployed within anorganization’s internal infrastructure, allowing healthcare providers to maintain full control over medical imaging data while leveraging advanced AI-assisted visualization tools. Clinical AI solutions refer to separate medical device software and are not included within the scope of this system. FDA UDI

Identifiers

Primary DI / UDI-DI
08800046800167 FDA UDI
FDA Product Code
LMD FDA UDI
GMDN Term
Radiological image interpretive software sharing portal FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
892.2020 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Radiological image interpretive software sharing portal

ClariPlatform by ClariPI Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radiological image interpretive software sharing portal.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
ClariPI Inc.

Sources (1)

  • FDA UDI 81516e33-ae12-422e-a6d2-198f78e8d7c2 33 fields · synced May 30, 2026