2D Abdominal Probe
FDA UDIEUDAMEDClass II (US FDA UDI)
by Koelis
Identity
- Trade Name
- 2D Abdominal Probe EUDAMEDFDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Device Name
- TRINITY EUDAMEDSurface 2D probe (Convex) to be used with TRINITY ultrasound system KURO-3000-X This probe is used for 2D exam for Abdominal, Gynecology, Musculoskeletal, soft tissues, Urology and Vascular applications Frequencies: 2-5MHz Field of view 460° Radius 60 mm FDA UDI
- Model / Reference
- K2DAB00 EUDAMEDFDA UDITRINITY EUDAMED
- Description
- Surface 2D probe (Convex) to be used with TRINITY ultrasound system KURO-3000-X This probe is used for 2D exam for Abdominal, Gynecology, Musculoskeletal, soft tissues, Urology and Vascular applications Frequencies: 2-5MHz Field of view 460° Radius 60 mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03665134000097 EUDAMEDFDA UDI
- Basic UDI-DI
- 3665134TRINITY_01PL EUDAMED
- 510(k) Number
- K170521 FDA UDI
- FDA Product Code
- ITX FDA UDI
- EMDN Code
- Z110402010201 CURVILINEAR TRANSCUTANEOUS TWO–DIMENSIONAL ULTRASOUND PROBES (CONVEX–ARRAY) EUDAMED
- GMDN Term
- General-purpose ultrasound imaging system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1570 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: General-purpose ultrasound imaging system
2D Abdominal Probe by Koelis — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K170521 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Koelis
Sources (2)
- FDA UDI 9ff5ee98-24da-481a-ac9f-863e0ec8656f 36 fields · synced Jul 9, 2026
- EUDAMED 77713e14-8c72-400d-95b1-f3738c68cb4f 61 fields · synced Jul 9, 2026