Perfusion Package for Magnetom Vision and Symphony Systems
FDA 510(k) K984224 · Siemens Corp.
510(k) numberK984224
Submission
- Device name
- Perfusion Package for Magnetom Vision and Symphony Systems
- Applicant
- Siemens Corp.
Iselin, NJ, US - Received
- November 25, 1998
- Decision date
- February 2, 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 Perfusion Package for Magnetom Vision and Symphony Systems cleared by the FDA?
Perfusion Package for Magnetom Vision and Symphony Systems (K984224) received a 510(k) decision of Substantially Equivalent on February 2, 1999, 69 days after the submission was received.
What is the product code of K984224?
The FDA product code is LNH – System, Nuclear Magnetic Resonance Imaging, a Class II (moderate risk) device regulated under 21 CFR 892.1000.