Qplaque MR
FDA 510(k) K073156 · Medis Medical Imaging Systems BV
510(k) numberK073156
Submission
- Device name
- Qplaque MR
- Applicant
- Medis Medical Imaging Systems BV
Leiden, NL - Received
- November 8, 2007
- Decision date
- March 4, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Qplaque MR cleared by the FDA?
Qplaque MR (K073156) received a 510(k) decision of Substantially Equivalent on March 4, 2008, 117 days after the submission was received.
What is the product code of K073156?
The FDA product code is LNH – System, Nuclear Magnetic Resonance Imaging, a Class II (moderate risk) device regulated under 21 CFR 892.1000.