Identity
- Trade Name
- EchoNous System FDA UDI
- Generic Name
- Hand-held ultrasound imaging system, body-surface FDA UDI
- Device Name
- General ultrasound imaging system, battery-powered FDA UDI
- Model / Reference
- P006705 FDA UDI
- Description
- General ultrasound imaging system, battery-powered FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09353278000533 FDA UDI
- 510(k) Number
- K181574 FDA UDI
- FDA Product Code
- IYO FDA UDI
- GMDN Term
- Hand-held ultrasound imaging system, body-surface 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
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: Hand-held ultrasound imaging system, body-surface
EchoNous System by EchoNous — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hand-held ultrasound imaging system, body-surface.
- Biim Android App, P1.3 — Biim Ultrasound AS · Class II
- Battery Charger AU, Biim Ultrasound — Biim Ultrasound AS · Class II
- Clarius Ultrasound Scanner — Clarius Mobile Health Corp · Class II
- Battery Charger UK, Biim Ultrasound — Biim Ultrasound AS · Class II
- GUI — Sonivate Medical, Inc. · Class II
- Clarius Ultrasound Scanner — Clarius Mobile Health Corp · Class II
- Butterfly iQ3 Charger Kit — Butterfly Network, Inc. · Class II
- Clarius Ultrasound Scanner — Clarius Mobile Health Corp · Class II
Cleared under the same submission
K181574 also covers:
- EchoNous Bladder Probe — EchoNous
- EchoNous Bladder Probe - Refurbished — EchoNous
- EchoNous System — EchoNous
- EchoNous System (Refurbished) — EchoNous
- EchoNous System (Refurbished) — EchoNous
- EchoNous System - Refurbished — EchoNous
- Hub — 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 2e3c6377-5923-41e0-b221-0d9f28db5f42 35 fields · synced Jun 8, 2026