Uc-Care Navigo Sytem
FDA 510(k) K100784 · UC-CARE , Ltd.
510(k) numberK100784
Submission
- Device name
- Uc-Care Navigo Sytem
- Applicant
- UC-CARE , Ltd.
Washington, DC, US - Received
- March 19, 2010
- Decision date
- November 1, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Uc-Care Navigo Sytem cleared by the FDA?
Uc-Care Navigo Sytem (K100784) received a 510(k) decision of Substantially Equivalent on November 1, 2011, 592 days after the submission was received.
What is the product code of K100784?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.