Medrad Quadrature CTL Array Coil
FDA 510(k) K984159 · Medrad, Inc.
510(k) numberK984159
Submission
- Device name
- Medrad Quadrature CTL Array Coil
- Applicant
- Medrad, Inc.
Indianola, PA, US - Received
- November 19, 1998
- Decision date
- January 12, 1999
- 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 Quadrature CTL Array Coil cleared by the FDA?
Medrad Quadrature CTL Array Coil (K984159) received a 510(k) decision of Substantially Equivalent on January 12, 1999, 54 days after the submission was received.
What is the product code of K984159?
The FDA product code is MOS – Coil, Magnetic Resonance, Specialty, a Class II (moderate risk) device regulated under 21 CFR 892.1000.