Cleared Traditional

K211064 - nView s1 with nav option

K211064 is an FDA 510(k) clearance for nView s1 with nav option, manufactured by Nview Medical. The device is a Class 2 Radiology device with product code OWB cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K211064 · Nview Medical · Radiology device
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Oct 2021
Decision
203d
Days
Class 2
Risk

K211064 is an FDA 510(k) clearance for the nView s1 with nav option. Classified as Interventional Fluoroscopic X-ray System (product code OWB), Class II - Special Controls.

Submitted by Nview Medical (Salt Lake City, US). The FDA issued a Cleared decision on October 29, 2021 after a review of 203 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1650 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

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FDA 510(k) Submission Details - K211064

510(k) Number K211064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 2021
Decision Date October 29, 2021
Days to Decision 203 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d slower than avg
Panel avg: 107d · This submission: 203d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OWB Device Classification - Class 2, Special Controls

Product Code OWB Interventional Fluoroscopic X-ray System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
Definition Interventional Fluoroscopy
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

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All 245
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