SIGNA Pioneer
FDA 510(k) K143345 · Ge Healthcare Japan Corporation
510(k) numberK143345
Submission
- Device name
- SIGNA Pioneer
- Applicant
- Ge Healthcare Japan Corporation
Hino-Shi, JP - Received
- November 21, 2014
- Decision date
- July 10, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was SIGNA Pioneer cleared by the FDA?
SIGNA Pioneer (K143345) received a 510(k) decision of Substantially Equivalent on July 10, 2015, 231 days after the submission was received.
What is the product code of K143345?
The FDA product code is LNH – System, Nuclear Magnetic Resonance Imaging, a Class II (moderate risk) device regulated under 21 CFR 892.1000.