FDA UDI
In Commercial Distribution
🇺🇸 United States
Change Healthcare Radiology Solutions
DI: 17540262030051
·
Model: 14.2.1
·
Change Healthcare Canada Company
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Change Healthcare Radiology Solutions
- Primary DI
- 17540262030051
- Version / Model
- 14.2.1
- Company Name
- Change Healthcare Canada Company
- Labeler DUNS
- 246576391
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-11-10
- Public Version
- 1
- Public Version Date
- 2023-11-20
- Public Version Status
- New
- Public Device Record Key
- 60fabe91-af07-49b8-b3d6-d0407f730f7c
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| LLZ | System, Image Processing, Radiological | Radiology | 892.2050 | 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 | 17540262030051 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K140909 | 000 |