Identity
- Trade Name
- TeraRecon Neuro EUDAMEDFDA UDI
- Generic Name
- Radiology DICOM image processing application software FDA UDI
- Device Name
- TeraRecon Neuro EUDAMEDTeraRecon 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. FDA UDI
- Model / Reference
- 2 EUDAMEDNeuro EUDAMEDNeuro02 FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- Neuro FDA UDI
- Primary DI / UDI-DI
- +B220NEURO020 EUDAMEDNEURO02 EUDAMEDFDA UDI
- Basic UDI-DI
- ++B220NeuroFP EUDAMEDB-NEURO02 EUDAMED
- Direct Marketing DI
- +B220NEURO020 EUDAMED
- 510(k) Number
- K220349 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- EMDN Code
- Z11030592 RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Radiology DICOM image processing application software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Special Device Type
- Software EUDAMED-1192 EUDAMED
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
TeraRecon Neuro by Terarecon Inc. — Class IIa — FDA_510K, MDD, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K220349 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | ++B220NeuroFP | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | ++B220NeuroFP | Class IIa | Active |
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Manufacturer
- Manufacturer
- TeraRecon, Inc.
- EUDAMED SRN
- US-MF-000008772
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (4)
- EUDAMED 7f2c8b80-3368-47af-bcbb-04d0b98eeb9b 61 fields · synced Sep 17, 2026
- EUDAMED d2b399ce-322b-4c78-bd4b-63e33f938623 61 fields · synced May 18, 2026
- FDA UDI 98457127-3f21-4ed2-9112-a0f9fb5ee2fb 35 fields · synced May 30, 2026
- FDA 510(k) K220349 1 fields · synced May 18, 2026