LungPrint
- Primary DI
- 00852426007015
- Brand
- LungPrint
- Company
- VIDA DIAGNOSTICS, INC.
- Model
- 1.x
- Device description
- LungPrint is an interactive software-based viewing and reporting platform that displays image analysis results for use by pulmonary care providers in the diagnosis and documentation of pulmonary tissue images.
- Published
- 2020-04-14
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| JAK | System, X-Ray, Tomography, Computed |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| JAK | System, X-Ray, Tomography, Computed | Radiology | 2 |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|
| K083227 | 000 | VIDA PULMONARY WORKSTATION 2 (PW2) | Vida Diagnostics, Inc. | 2008-11-18 | JAK |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00852426007015 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00852426007015 | 00852426007015 | 852426007015 | 0852426007015 |
GMDN Terms
| Term | Definition |
|---|
| CT system application software | An application software program intended to add specific image processing and/or analysis capabilities to an x-ray computed tomography (CT) imaging system; it is not dedicated to radiotherapy treatment planning. A basic set of applications programs and routines are included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some applications software routines or groups of routines must be combined with specific hardware or firmware accessories or configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and version or upgrade number. |
Regulatory Flags
- DUNS number
- 195621060
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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