Ge Signa Asset Imaging Option

FDA 510(k)

Class II (US FDA 510(k))

510(k) K012970

Identifiers

510(k) Number: K012970 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 GE SIGNA Asset Imaging Option is a cutting-edge nuclear magnetic resonance imaging (MRI) device designed for comprehensive medical imaging, providing high-resolution images of the body's internal structures. This device has undergone rigorous testing and evaluation to ensure its exceptional quality and safety, meeting the highest standards of regulatory compliance. The device is utilized in various medical specialties, including radiology, to diagnose and treat a wide range of conditions.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K012970	Class II	Active

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Manufacturer

Manufacturer: Ge Medical Systems

Sources (1)

FDA 510(k) K012970 24 fields · synced Oct 6, 2026