Identity
- Trade Name
- AmCAD-UO EUDAMEDAmCAD UO FDA UDI
- Generic Name
- Ultrasound imaging system application software FDA UDI
- Device Name
- AmCAD UO is a PC based, self contained, non invasive image analysis software application for reviewing the pharyngeal/upper airway ultrasonic image acquired from an FDA cleared ultrasound system. The software is designed to support visualization and quantification of the airway sonographic characteristics. The software also provides tools for manual or interactive selection of Region of Interest to allow for analysis of the airway in terms of its size, position and enhancement pattern. This analysis provides information for physician’s evaluation and monitoring of the airway state. FDA UDI
- Model / Reference
- UO-0102 EUDAMED1.0 FDA UDI
- Description
- AmCAD UO is a PC based, self contained, non invasive image analysis software application for reviewing the pharyngeal/upper airway ultrasonic image acquired from an FDA cleared ultrasound system. The software is designed to support visualization and quantification of the airway sonographic characteristics. The software also provides tools for manual or interactive selection of Region of Interest to allow for analysis of the airway in terms of its size, position and enhancement pattern. This analysis provides information for physician’s evaluation and monitoring of the airway state. FDA UDI
Identifiers
- Catalog Number
- UO-0102 FDA UDI
- Primary DI / UDI-DI
- 04719875623103 EUDAMEDFDA UDI
- Basic UDI-DI
- 471987562UO3A EUDAMED
- 510(k) Number
- K180867 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- EMDN Code
- Z12040182 GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
- GMDN Term
- Ultrasound imaging system application software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Special Device Type
- Software 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
Yes
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
AmCAD-UO by Amcad Biomed Corporation — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 471987562UO3A | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- AmCad BioMed Corporation
- EUDAMED SRN
- TW-MF-000013445
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED d9e7ad01-6f2a-49c5-983d-62cb470a2d1c 61 fields · synced Jul 15, 2026
- FDA UDI 656245b2-fbe4-4b4f-81e3-32326ecfcabf 35 fields · synced May 30, 2026