2D Linear Probe
FDA UDIEUDAMEDClass II (US FDA UDI)
by Koelis
Identity
- Trade Name
- 2D Linear Probe EUDAMEDFDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Device Name
- TRINITY EUDAMEDSurface 2D probe (linear) to be used with TRINITY ultrasound system KURO-3000-X This probe is used for 2D exam for Abdominal, Gynecology, Musculoskeletal, small organs, soft tissues, urology and vascular applications Frequencies: 7-15MHz Field of view 40 mm FDA UDI
- Model / Reference
- K2DLN00 EUDAMEDFDA UDITRINITY EUDAMED
- Description
- Surface 2D probe (linear) to be used with TRINITY ultrasound system KURO-3000-X This probe is used for 2D exam for Abdominal, Gynecology, Musculoskeletal, small organs, soft tissues, urology and vascular applications Frequencies: 7-15MHz Field of view 40 mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03665134000103 EUDAMEDFDA UDI
- Basic UDI-DI
- 3665134TRINITY_01PL EUDAMED
- 510(k) Number
- K170521 FDA UDI
- FDA Product Code
- ITX FDA UDI
- EMDN Code
- Z110402010101 TWO–DIMENSIONAL LINEAR–ARRAY TRANSCUTANEOUS ULTRASOUND PROBES 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 Linear Probe by Koelis — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as General-purpose ultrasound imaging system.
- SE12-3 Gen II® — SUPERSONIC IMAGINE · Class II
- SUPERSONIC MACH 40 — SUPERSONIC IMAGINE · Class II
- HS50 — SAMSUNG MEDISON CO., LTD · Class II
- EBit Series Diagnostic Ultrasound System — CHISON Medical Technologies Co., Ltd. · Class II
- Display Module(M5, International, Alone) — Shenzhen Mindray Bio-Medical Electronics Co. · Class II
- WS80A Diagnostic Ultrasound System — SAMSUNG MEDISON CO., LTD · Class II
- HS50 / HS60 Diagnostic Ultrasound System — SAMSUNG MEDISON CO., LTD · Class II
- MEDISONO — Medisono, LLC · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Koelis
Sources (2)
- FDA UDI 133b24a8-35f0-4a5e-bacb-13b19dafe948 36 fields · synced Jul 21, 2026
- EUDAMED 8abc4b7e-e14c-4a50-bfe5-dbc8d6688128 61 fields · synced Jul 21, 2026