3D Side-Fire Endocavity Probe
FDA UDIEUDAMEDClass II (US FDA UDI)
by Koelis
Identity
- Trade Name
- Side-Fire Endocavitary 3D ultrasound probes EUDAMED3D Side-Fire Endocavity Probe FDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Device Name
- TRINITY EUDAMEDInvasive 2D/3D endocavity probe (linear) to be used with TRINITY ultrasound system KURO-3000-X This probe is used for 2D exam, 3D mapping, for urology application. Frequencies: 4-9 MHz Field of view 72 mm Scanning angle 170° FDA UDI
- Model / Reference
- K3DEL00 EUDAMEDFDA UDITRINITY EUDAMED
- Description
- Invasive 2D/3D endocavity probe (linear) to be used with TRINITY ultrasound system KURO-3000-X This probe is used for 2D exam, 3D mapping, for urology application. Frequencies: 4-9 MHz Field of view 72 mm Scanning angle 170° FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03665134000080 EUDAMEDFDA UDI
- Basic UDI-DI
- 3665134TRINITY_01PL EUDAMED
- 510(k) Number
- K170521 FDA UDI
- FDA Product Code
- ITX FDA UDI
- EMDN Code
- Z1104020202 ENDOCAVITARY ULTRASOUND PROBES, MULTIDIMENSIONAL 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
3D Side-Fire Endocavity 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 b94e2855-06b9-414d-a6e6-87d1dddc2331 36 fields · synced Jun 19, 2026
- EUDAMED c3c6b522-66e8-417d-aa17-9a73f5bbadc1 61 fields · synced Jun 19, 2026