GE Quadrature T/L Spine Surf Coil, M1085AP/M1285AP
FDA 510(k) K902663 · General Electric Co.
510(k) numberK902663
Submission
- Device name
- GE Quadrature T/L Spine Surf Coil, M1085AP/M1285AP
- Applicant
- General Electric Co.
Milwaukee, WI, US - Received
- June 18, 1990
- Decision date
- September 20, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was GE Quadrature T/L Spine Surf Coil, M1085AP/M1285AP cleared by the FDA?
GE Quadrature T/L Spine Surf Coil, M1085AP/M1285AP (K902663) received a 510(k) decision of Substantially Equivalent on September 20, 1990, 94 days after the submission was received.
What is the product code of K902663?
The FDA product code is LNH – System, Nuclear Magnetic Resonance Imaging, a Class II (moderate risk) device regulated under 21 CFR 892.1000.