Identity
- Trade Name
- Hub FDA UDI
- Generic Name
- Ultrasound imaging system multi-transducer connection unit FDA UDI
- Device Name
- An electronic unit that supports switching between multiple transducers, and charging of the display tablet and transducers. FDA UDI
- Model / Reference
- P005324 FDA UDI
- Description
- An electronic unit that supports switching between multiple transducers, and charging of the display tablet and transducers. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09353278000069 FDA UDI
- 510(k) Number
- K181574 FDA UDI
- FDA Product Code
- IYO FDA UDI
- GMDN Term
- Ultrasound imaging system multi-transducer connection unit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1560 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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: Medical networking interface unitUltrasound imaging system multi-transducer connection unit
Hub by EchoNous — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ultrasound imaging system multi-transducer connection unit.
- Terason — Teratech Corporation · Class II
- Terason — Teratech Corporation · Class II
- Hub - Refurbished — EchoNous · Class II
Cleared under the same submission
K181574 also covers:
- EchoNous Bladder Probe — EchoNous
- EchoNous Bladder Probe - Refurbished — EchoNous
- EchoNous System — EchoNous
- EchoNous System — EchoNous
- EchoNous System (Refurbished) — EchoNous
- EchoNous System (Refurbished) — EchoNous
- EchoNous System - Refurbished — EchoNous
- Hub - Refurbished — EchoNous
- Mobile Stand — EchoNous
- Uscan Linear Probe — EchoNous
- Uscan Linear Probe — EchoNous
- Uscan Mobile Stand — EchoNous
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- EchoNous
Sources (1)
- FDA UDI 9f821026-174b-4994-815e-473d0b841ba4 34 fields · synced May 30, 2026