Cleared Traditional

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

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
Combination Product No
PCCP Authorized No
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.

Regulatory Consultant

Mtechgroup
Dave Kim

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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