UroNav (Version 3.0)
FDA 510(k) K182561 · Invivo Corporation
510(k) numberK182561
Submission
- Device name
- UroNav (Version 3.0)
- Applicant
- Invivo Corporation
Florida, FL, US - Received
- September 18, 2018
- Decision date
- October 19, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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Questions and answers
When was UroNav (Version 3.0) cleared by the FDA?
UroNav (Version 3.0) (K182561) received a 510(k) decision of Substantially Equivalent on October 19, 2018, 31 days after the submission was received.
What is the product code of K182561?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.