Eu Mdd
Eu Md Class 2a
On The Market
๐บ๐ธ United States
TeraRecon Neuro
Devices (same UDI-DI)
1
Certificates
1
Countries
18
Notified Bodies
1
Basic Information
- Primary DI
- NEURO02
- Basic UDI-DI Code
- B-NEURO02
- Reference
- Neuro
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- TeraRecon, Inc.
Additional Description
TeraRecon Neuro allows motion correction and processes, calculates and outputs brain perfusion analysis results for functional, dynamic, and derived imaging datasets acquired with CT or MRI. TeraRecon Neuro results are used for the analysis of dynamic brain perfusion image data, showing properties of changes in contrast over time. This functionality includes calculation of parameters related to brain tissue perfusion, vascular assessment and tissue blood volume.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z11030592 | RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | HD 60146453 0001 | TรV Rheinland LGA Products GmbH | Expired |
Available In Countries
๐ฆ๐น Austria
๐ง๐ช Belgium
๐ฉ๐ช Germany
๐ช๐ช Estonia
๐ช๐ธ Spain
๐ซ๐ฎ Finland
๐ซ๐ท France
๐ฎ๐ช Ireland
๐ฎ๐ธ Iceland
๐ฎ๐น Italy
๐ฑ๐ฎ Liechtenstein
๐ฑ๐บ Luxembourg
๐ฒ๐น Malta
๐ณ๐ฑ Netherlands
๐ต๐ฑ Poland
๐ต๐น Portugal
๐ธ๐ฎ Slovenia
๐ฌ๐ง United Kingdom
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