Sonic DL
FDA 510(k) K243667 · Ge Medical Systems, LLC
510(k) numberK243667
Submission
- Device name
- Sonic DL
- Applicant
- Ge Medical Systems, LLC
Waukesha, WI, US - Received
- November 27, 2024
- Decision date
- June 5, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Sonic DL cleared by the FDA?
Sonic DL (K243667) received a 510(k) decision of Substantially Equivalent on June 5, 2025, 190 days after the submission was received.
What is the product code of K243667?
The FDA product code is LNH – System, Nuclear Magnetic Resonance Imaging, a Class II (moderate risk) device regulated under 21 CFR 892.1000.