Medis Suite XA 2D
Basic Information
- Brand Name
- Medis Suite XA 2D
- Primary DI
- B141MEDISSUITEXA2D20190
- Version / Model
- 2019
- 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
- 2020-02-20
- Public Version
- 2
- Public Version Date
- 2022-03-22
- Public Version Status
- Update
- Public Device Record Key
- 8294adf4-32a5-428d-b5da-04287d323d31
Device Description
Medis Suite XA is software intended to be used for performing calculations in X-ray angiographic images of the chambers of the heart and of blood vessels. These calculations are based on contours that are either manually drawn by the clinician or trained medical technician who is operating the software, or automatically detected by the software and subsequently presented for review and manual editing. Medis Suite XA is also intended to be used for performing caliper measurements. The results obtained are displayed on top of the images and provided in reports. The analysis results obtained with Medis Suite XA are intended for use by cardiologists and radiologists: • to support clinical decisions concerning the heart and vessels • to support the evaluation of interventions or drug therapy applied for conditions of the heart and vessels
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 | B141MEDISSUITEXA2D20190 | HIBCC | ||||
| Previous | B141MEDISSUITEXA2D20180 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K112807 | 000 |