nView s1 with nav option
FDA 510(k) K211064 · Nview Medical
510(k) numberK211064
Submission
- Device name
- nView s1 with nav option
- Applicant
- Nview Medical
Salt Lake City, UT, US - Received
- April 9, 2021
- Decision date
- October 29, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K252503 | Intelligent NROWB · Traditional | Canon, Inc. | 04/30/2026SE |
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| K252229 | Belliger AceOWB · Traditional | Genoray Co., Ltd. | 04/02/2026SE |
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Questions and answers
When was nView s1 with nav option cleared by the FDA?
nView s1 with nav option (K211064) received a 510(k) decision of Substantially Equivalent on October 29, 2021, 203 days after the submission was received.
What is the product code of K211064?
The FDA product code is OWB – Interventional Fluoroscopic X-Ray System, a Class II (moderate risk) device regulated under 21 CFR 892.1650.