Identity
- Trade Name
- Medis Suite XA 2D FDA UDI
- Generic Name
- Laboratory instrument/analyser application software IVD FDA UDI
- Device Name
- 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 FDA UDI
- Model / Reference
- 2018 FDA UDI
- 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 FDA UDI
Identifiers
- Primary DI / UDI-DI
- B141MEDISSUITEXA2D20180 FDA UDI
- 510(k) Number
- K112807 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- GMDN Term
- Laboratory instrument/analyser application software IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Laboratory instrument/analyser application software IVD
Medis Suite XA 2D by Medis Medical Imaging Systems B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K112807 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Medis Medical Imaging Systems B.V.
Sources (1)
- FDA UDI faa7a1b2-ce25-4713-b227-e0e947dad345 34 fields · synced May 29, 2026