Cleared Traditional

K160279 - ANYVIEW-500R Fluoroscopic Mobile X-Ray ...

K160279 is an FDA 510(k) clearance for ANYVIEW-500R Fluoroscopic Mobile X-Ray ..., manufactured by Ecotron Co., Ltd.. The device is a Class 2 Radiology device with product code OWB cleared through the Traditional 510(k) pathway after a 255-day FDA review.

K160279 · Ecotron Co., Ltd. · Radiology device
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Oct 2016
Decision
255d
Days
Class 2
Risk

K160279 is an FDA 510(k) clearance for the ANYVIEW-500R Fluoroscopic Mobile X-Ray System. Classified as Interventional Fluoroscopic X-ray System (product code OWB), Class II - Special Controls.

Submitted by Ecotron Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on October 14, 2016 after a review of 255 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.

View all Ecotron Co., Ltd. devices

FDA 510(k) Submission Details - K160279

510(k) Number K160279 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2016
Decision Date October 14, 2016
Days to Decision 255 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
148d slower than avg
Panel avg: 107d · This submission: 255d
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 246
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