Identity
- Trade Name
- Automation Platform FDA UDI
- Generic Name
- Radiological PACS software FDA UDI
- Device Name
- This product is a software product that transfers, stores, converts formats, and displays medical device image data. It does not modify the image data or modify the display of the image data. This product reads images and interprets DICOM tags, analyzes pixels to identify body part and sequence type in order to categorize the images. This product is not intended to be used for active patient monitoring nor image interpretation. This product allows to route DICOM-compliant image data to and from automated post processing applications, but such processing applications are not a part of the platform itself. This product allows post processing applications to provide a notification or a flag intended to inform the user. FDA UDI
- Model / Reference
- SCAI-1PF FDA UDI
- Description
- This product is a software product that transfers, stores, converts formats, and displays medical device image data. It does not modify the image data or modify the display of the image data. This product reads images and interprets DICOM tags, analyzes pixels to identify body part and sequence type in order to categorize the images. This product is not intended to be used for active patient monitoring nor image interpretation. This product allows to route DICOM-compliant image data to and from automated post processing applications, but such processing applications are not a part of the platform itself. This product allows post processing applications to provide a notification or a flag intended to inform the user. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987670104329 FDA UDI
- FDA Product Code
- LMD FDA UDI
- GMDN Term
- Radiological PACS software 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
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Radiological PACS software
Automation Platform by Canon Medical Systems Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- QuantX — Qlarity Imaging · Class II
- interWORKS — Avreo, Inc. · Class I
- NovaPACS — Novarad Corporation · Class II
- OrthoNext™ Platform System Software — Orthofix, Inc. · Class II
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
- Canon Medical Systems Corporation
Sources (1)
- FDA UDI b432a66b-5c48-441f-a00e-38f01891519a 34 fields · synced May 30, 2026