Identity
- Trade Name
- ClariPlatform FDA UDI
- Generic Name
- Radiological image interpretive software sharing portal FDA UDI
- Device Name
- ClariPlatform (Ver. 1.0) is a medical imaging platform that hosts clinical AI solutions in a cloud-based SaaS format. The system facilitates the networking, filtering, routing, and 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. ClariPlatform is only deployed on the cloud, ensuring accessibility and compliance with regulations. Clinical AI solutions refer to separate medical device software and are not included within the scope of this system. FDA UDI
- Model / Reference
- 1.0 FDA UDI
- Description
- ClariPlatform (Ver. 1.0) is a medical imaging platform that hosts clinical AI solutions in a cloud-based SaaS format. The system facilitates the networking, filtering, routing, and 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. ClariPlatform is only deployed on the cloud, ensuring accessibility and compliance with regulations. 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
- 08800046800150 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.
- Eureka — Terarecon Inc. · Class I
- ClariPlatform — ClariPI Inc. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- ClariPI Inc.
Sources (1)
- FDA UDI c6838315-808c-44d2-8cc1-c36d27b0250c 33 fields · synced May 30, 2026