Identity
- Trade Name
- SONIC SHOT GX FDA UDI
- Generic Name
- MRI contrast medium injection system, line-powered, mobile FDA UDI
- Device Name
- Nemoto SONIC SHOT GX contrast delivery system for MRI applications. FDA UDI
- Model / Reference
- 070 FDA UDI
- Description
- Nemoto SONIC SHOT GX contrast delivery system for MRI applications. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04560138480700 FDA UDI
- 510(k) Number
- K091734 FDA UDI
- FDA Product Code
- IZQ FDA UDI
- GMDN Term
- MRI contrast medium injection system, line-powered, mobile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1650 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
No
FDA UDI
MR Conditional FDA UDI
Category: MRI contrast medium injection system, line-powered, mobile
Sonic Shot Gx by Nemoto Kyorindo Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as MRI contrast medium injection system, line-powered, mobile.
- ulricheasyINJECT Max — Ulrich GmbH & Co. KG · Class II
- MEDRAD® MRXperion MR Injection System — Bayer Medical Care Inc. · Class II
- Penetration Panel — Bracco Injeneering · Class II
- ulricheasyINJECT Max — Ulrich GmbH & Co. KG · Class II
- EmpowerMR® Injector System without Remote Control — Bracco Injeneering · Class II
- Electro-Hydraulic Interconnect — Bracco Injeneering · Class II
- MEDRAD® MRXperion MR Injection System — Bayer Medical Care Inc. · Class II
- ulricheasyINJECT Max — Ulrich GmbH & Co. KG · Class II
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
- Nemoto Kyorindo Co., Ltd.
Sources (1)
- FDA UDI 94cc4ddd-481a-445c-a271-b3cb061ae886 35 fields · synced Jun 1, 2026