Vantage Elan
FDA 510(k) K141472 · Toshiba America Medical Systems, In.C
510(k) numberK141472
Submission
- Device name
- Vantage Elan
- Applicant
- Toshiba America Medical Systems, In.C
Tustin, CA, US - Received
- June 3, 2014
- Decision date
- September 19, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Vantage Elan cleared by the FDA?
Vantage Elan (K141472) received a 510(k) decision of Substantially Equivalent on September 19, 2014, 108 days after the submission was received.
What is the product code of K141472?
The FDA product code is LNH – System, Nuclear Magnetic Resonance Imaging, a Class II (moderate risk) device regulated under 21 CFR 892.1000.