Identity
- Trade Name
- Mobile Stand FDA UDI
- Generic Name
- Radiological imaging system transport kit FDA UDI
- Device Name
- Radiological imaging system transport kit FDA UDI
- Model / Reference
- P005149 FDA UDI
- Description
- Radiological imaging system transport kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09353278000052 FDA UDI
- 510(k) Number
- K181574 FDA UDI
- FDA Product Code
- IYO FDA UDI
- GMDN Term
- Radiological imaging system transport kit 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Radiological imaging system transport kit
Mobile Stand by EchoNous — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Radiological imaging system transport kit.
- Site-Rite — Bard Access Systems, Inc. · Class II
- Uscan Mobile Stand — EchoNous · Class II
- Uscan Mobile Stand — 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 — EchoNous
- Hub - Refurbished — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- EchoNous
Sources (1)
- FDA UDI 1e502222-3839-42d7-9026-2359bfa7b35b 34 fields · synced Jun 1, 2026