High Ends Gradients/Magnetom Symphony System
FDA 510(k) K991652 · Siemens Corp.
510(k) numberK991652
Submission
- Device name
- High Ends Gradients/Magnetom Symphony System
- Applicant
- Siemens Corp.
Iselin, NJ, US - Received
- May 13, 1999
- Decision date
- August 3, 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 High Ends Gradients/Magnetom Symphony System cleared by the FDA?
High Ends Gradients/Magnetom Symphony System (K991652) received a 510(k) decision of Substantially Equivalent on August 3, 1999, 82 days after the submission was received.
What is the product code of K991652?
The FDA product code is LNH – System, Nuclear Magnetic Resonance Imaging, a Class II (moderate risk) device regulated under 21 CFR 892.1000.