Identity
- Trade Name
- Remote Control FDA UDI
- Generic Name
- Contrast medium injection system control unit FDA UDI
- Device Name
- EmpowerMR 17" Remote 1722 FDA UDI
- Model / Reference
- 017380 FDA UDI
- Description
- EmpowerMR 17" Remote 1722 FDA UDI
Identifiers
- Catalog Number
- 017380 FDA UDI
- Primary DI / UDI-DI
- 17630039300378 FDA UDI
- 510(k) Number
- K062449 FDA UDI
- FDA Product Code
- IZQ FDA UDI
- GMDN Term
- Contrast medium injection system control unit 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
Yes
FDA UDI
Category: Contrast medium injection system control unit
Remote Control by Bracco Injeneering — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K062449 also covers:
- Accessory Kit — Bracco Injeneering
- Electro-Hydraulic Interconnect — Bracco Injeneering
- Empower MR Injector Head — Bracco Injeneering
- EmpowerMR® Injector System without Remote Control — Bracco Injeneering
- EmpowerMR® Injector System without Remote Control — Bracco Injeneering
- FastLoad™ MR Syringe Pack — Bracco Injeneering
- FastLoad™ MR Syringe Pack — Bracco Injeneering
- FastLoad™ MR Syringe Pack — Bracco Injeneering
- Floor Stand — Bracco Injeneering
- Hydraulic Controller — Bracco Injeneering
- Penetration Panel — Bracco Injeneering
- Remote Control — Bracco Injeneering
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
- Bracco Injeneering
Sources (1)
- FDA UDI 157739b9-f376-4ad5-b2b4-ce865d6097d8 37 fields · synced May 30, 2026