FDA UDI
In Commercial Distribution
🇺🇸 United States
LMS-Liver
DI: 03760263520024
·
Model: 6.0
·
MEDIAN TECHNOLOGIES
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LMS-Liver
- Primary DI
- 03760263520024
- Version / Model
- 6.0
- Company Name
- MEDIAN TECHNOLOGIES
- Labeler DUNS
- 265359856
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-14
- Public Version
- 6
- Public Version Date
- 2023-10-18
- Public Version Status
- Update
- Public Device Record Key
- 66790a9e-52ae-4548-87f2-8a6e5f339fab
Device Description
LMS-Liver is an image analysis software application for evaluating CT images covering the liver area. It is designed to assist radiologists in the evaluation and documentation of lesions. It also provides tools for assessment of lesion evolution over time. LMS-Liver offers measurement tools and 3D registration techniques for characterization and follow-up of the lesions. It also offers reporting capabilities making it possible to generate standardized reports.
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
- 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 |
|---|---|---|---|---|
| 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 | 03760263520024 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K071241 | 000 |