FDA UDI
In Commercial Distribution
🇺🇸 United States
ClearRead CT CAC Docker
DI: M722CD25281CA252790
·
Model: 1.2.2
·
Riverain Technologies, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ClearRead CT CAC Docker
- Primary DI
- M722CD25281CA252790
- Version / Model
- 1.2.2
- Company Name
- Riverain Technologies, Inc.
- Labeler DUNS
- 172223922
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-10-17
- Public Version
- 1
- Public Version Date
- 2025-10-27
- Public Version Status
- New
- Public Device Record Key
- 7606f0d0-6e76-4664-99d5-0adb2843c963
Device Description
ClearRead CT CAC Docker
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
- No
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | Radiology | 892.1750 | 2 |
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 | M722CD25281CA252790 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K242188 | 000 |