Stage
FDA 510(k) K223079 · Spintech, Inc.
510(k) numberK223079
Submission
- Device name
- Stage
- Applicant
- Spintech, Inc.
Bingham Farms, MI, US - Received
- September 30, 2022
- Decision date
- October 28, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Stage cleared by the FDA?
Stage (K223079) received a 510(k) decision of Substantially Equivalent on October 28, 2022, 28 days after the submission was received.
What is the product code of K223079?
The FDA product code is LNH – System, Nuclear Magnetic Resonance Imaging, a Class II (moderate risk) device regulated under 21 CFR 892.1000.