Identity
- Trade Name
- 1.5T DuoFLEX Standard Suite FDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Device Name
- The MR Instruments FC 1500G-8R DuoFLEX® Coil Suite includes two different sets of coil paddles and a single, shared preamplifier box with a system connector. The first coil set consists of two 24cm foam paddles containing four loops/channels per paddle for a total of eight channels for the two paddles. The second coil set consists of two 10cm square foam paddles containing four loops/channels per paddle for a total of eight channels for the two paddles. All of these paddles connect to the same preamplifier box containing eight preamplifiers; only one pair can be connected at a time. The coil design for all of the paddles has the same, simple antennae design and the same system connectivity configuration. The coils can be used in several configurations, including any single coil and any two coils, providing 4 or 8 channels for imaging. FDA UDI
- Model / Reference
- FC 1500G-8R FDA UDI
- Description
- The MR Instruments FC 1500G-8R DuoFLEX® Coil Suite includes two different sets of coil paddles and a single, shared preamplifier box with a system connector. The first coil set consists of two 24cm foam paddles containing four loops/channels per paddle for a total of eight channels for the two paddles. The second coil set consists of two 10cm square foam paddles containing four loops/channels per paddle for a total of eight channels for the two paddles. All of these paddles connect to the same preamplifier box containing eight preamplifiers; only one pair can be connected at a time. The coil design for all of the paddles has the same, simple antennae design and the same system connectivity configuration. The coils can be used in several configurations, including any single coil and any two coils, providing 4 or 8 channels for imaging. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00857371006014 FDA UDI
- 510(k) Number
- K130706 FDA UDI
- FDA Product Code
- MOS FDA UDI
- GMDN Term
- MRI system coil, radio-frequency FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1000 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: MRI system coil, radio-frequency
1.5T DuoFLEX Standard Suite by Mr Instruments, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Mr Instruments, Inc.
Sources (1)
- FDA UDI 98046d6c-3250-4a73-86b8-84b6a8db6e1f 34 fields · synced Jun 7, 2026