Identifiers
- 510(k) Number
- K081028 FDA 510(k)
- FDA Product Code
- LNH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1000 FDA 510(k)
- Regulation Number
- 892.1000 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Signa 3.0T MR750 System is a nuclear magnetic resonance imaging system. It utilizes a superconducting magnet operating at 3.0 Tesla and features a data acquisition system that accommodates up to 32 independent receive channels.
This device is manufactured by GE Medical Systems, LLC and has received FDA 510(k) clearance. It is categorized under the radiology medical specialty.
Frequently asked questions
What is the primary function of the Signa 3.0T MR750 System?
The Signa 3.0T MR750 System is a nuclear magnetic resonance imaging system. It is designed to perform diagnostic imaging by utilizing a superconducting magnet operating at a field strength of 3.0 Tesla.
What are the data acquisition capabilities of this system?
This system features a data acquisition system that is capable of accommodating up to 32 independent receive channels, allowing for the processing of imaging data during the scanning process.
What is the regulatory status of the Signa 3.0T MR750 System?
The Signa 3.0T MR750 System, manufactured by GE Medical Systems, LLC, has received FDA 510(k) clearance. It is classified under the radiology medical specialty.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: SIGNA 3.0T MR750 SYSTEM (K081028) — FDA 510 (k) | Innolitics, GE HealthCare MR750W Signa 3T MRI Scanners Instruction Manual, PDF K081028 SIGNA 3.0T MR750 SYSTEM - 510kdatabase.net
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K081028 | Class II | Active |
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Manufacturer
- Manufacturer
- GE Medical Systems, LLC
Sources (1)
- FDA 510(k) K081028 24 fields · synced Sep 22, 2026