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3D Side Fire Endocavity Probe
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref K3DEL00-2Model 3D Side-Fire Endocavity compact probe
by Koelis
Identity
- Trade Name
- 3D Side-Fire Endocavity compact probe EUDAMED3D Side Fire Endocavity Probe FDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Device Name
- Compact PERINE Probe. 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
- Model / Reference
- K3DEL00-2 EUDAMEDFDA UDI3D Side-Fire Endocavity compact probe EUDAMED
- Description
- Compact PERINE Probe. 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
- Catalog Number
- K3DEL00-2 FDA UDI
- Primary DI / UDI-DI
- 03665134000844 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03665134000844 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
- 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: General-purpose ultrasound imaging system
3D Side Fire Endocavity Probe by Koelis — Class II — MDD, 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
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | 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 a7f179ba-1f3e-46ea-814f-447fb36eae6b 37 fields · synced Jul 15, 2026
- EUDAMED 041ee8cc-4795-4fa8-8f51-5b668040d48d 61 fields · synced Jul 15, 2026