Ventripoint Medical System Plus (VMS+) 3.0
FDA 510(k) K191493 · Ventripoint Diagnostics , Ltd.
510(k) numberK191493
Submission
- Device name
- Ventripoint Medical System Plus (VMS+) 3.0
- Applicant
- Ventripoint Diagnostics , Ltd.
Toronto, CA - Received
- June 5, 2019
- Decision date
- October 16, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Ventripoint Medical System Plus (VMS+) 3.0 cleared by the FDA?
Ventripoint Medical System Plus (VMS+) 3.0 (K191493) received a 510(k) decision of Substantially Equivalent on October 16, 2019, 133 days after the submission was received.
What is the product code of K191493?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.