FDA UDI
In Commercial Distribution
🇺🇸 United States
LMS-Lung/TRACK
DI: 03760263520017
·
Model: 6.0
·
MEDIAN TECHNOLOGIES
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LMS-Lung/TRACK
- Primary DI
- 03760263520017
- 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
- 1376f27c-7290-4465-82ca-77232f1d98f1
Device Description
LMS-Lung/TRACK is intended to provide the radiologists and other clinicians qualified to interpret CT images the ability to: - visualize chest CT datasets acquired in low or normal dose; - mark and automatically/manually measure characteristics (such as diameter, volume) of lung nodules selected by the user; - compare chest CT scans of the same patient over time for quantification of pulmonary lesion evolution (volume growth and doubling time estimation) - generate automatic 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 |
| 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 | 03760263520017 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K070868 | 000 |