Medrad Quad C-Spine Coil, 1.5T Model, M64CSC, 1.0T Model M42CSC
FDA 510(k) K982959 · Medrad, Inc.
510(k) numberK982959
Submission
- Device name
- Medrad Quad C-Spine Coil, 1.5T Model, M64CSC, 1.0T Model M42CSC
- Applicant
- Medrad, Inc.
Indianola, PA, US - Received
- August 24, 1998
- Decision date
- November 3, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Medrad Quad C-Spine Coil, 1.5T Model, M64CSC, 1.0T Model M42CSC cleared by the FDA?
Medrad Quad C-Spine Coil, 1.5T Model, M64CSC, 1.0T Model M42CSC (K982959) received a 510(k) decision of Substantially Equivalent on November 3, 1998, 71 days after the submission was received.
What is the product code of K982959?
The FDA product code is LNH – System, Nuclear Magnetic Resonance Imaging, a Class II (moderate risk) device regulated under 21 CFR 892.1000.