QIvus
Basic Information
- Brand Name
- QIvus
- Primary DI
- B141QIVUS300
- Version / Model
- 3.0
- Company Name
- Medis Medical Imaging Systems B.V.
- Labeler DUNS
- 549961191
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-04-21
- Public Version
- 1
- Public Version Date
- 2026-04-29
- Public Version Status
- New
- Public Device Record Key
- 157605c4-eb84-4925-8481-4ed1f462a696
- Distribution End Date
- 2028-12-31
Device Description
QIvus has been developed for the objective and reproducible analysis of tomographic images of both lumen and arterial wall of a coronary or vascular segment, in particular the assessment of a stenosis or artherosclerotic plaque. This information supports the possible placement of intervention devices in these vessels. QIvus enables an advanced assessment of vessel, lumen, and stent morphology. It also avoids the very time-consuming conventional manual tracing of boundaries, which suffers from high intra- and inter observer variability. QIvus can be used to control stent placement and to assess in-stent restenosis. QIvus software package enables the automatic calculation and the display of various parameters such as: areas and diameters in individual slices; volumes over the segment of interest (Simpson’s Rule) for the vessel, lumen and stent contours; plaque and in-stent restenosis parameters.
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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| 43472 | Laboratory instrument/analyser application software IVD | An in vitro diagnostic software program intended to be used with an instrument/analyser (e.g., microscope slide digital imaging scanner, immunoassay analyser, real-time PCR machine), or a data management device connected to the instrument/analyser, to: 1) facilitate user-controlled device function [e.g., incubation control]; 2) assist data processing, display, or communication [e.g., image conversion]; and/or 3) produce raw-data-derived qualitative result calculations based on specified criteria [positive or negative assay result]. This software does not use demographic or clinical data to produce a patient score (i.e., it is not interpretive). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B141QIVUS300 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K011582 | 000 |