FDA UDI
In Commercial Distribution
🇺🇸 United States
Automation Platform
DI: 04987670104329
·
Model: SCAI-1PF
·
CANON MEDICAL SYSTEMS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Automation Platform
- Primary DI
- 04987670104329
- Version / Model
- SCAI-1PF
- Company Name
- CANON MEDICAL SYSTEMS CORPORATION
- Labeler DUNS
- 690575113
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-11-01
- Public Version
- 2
- Public Version Date
- 2023-10-18
- Public Version Status
- Update
- Public Device Record Key
- b432a66b-5c48-441f-a00e-38f01891519a
Device 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LMD | System, Digital Image Communications, Radiological | Radiology | 892.2020 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41670 | Radiological PACS software | An individual software application intended to be installed on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of radiological images. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04987670104329 | GS1 |
Customer Contacts
- Phone
- 8005211968
- [email protected]