Cleared Traditional

K172124 - Televere Podiatry Digital Imaging System

K172124 is the FDA 510(k) clearance for Televere Podiatry Digital Imaging System by Televere Systems. It is a Class 2 Radiology device (product code MQB) cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K172124 · Televere Systems · Radiology device
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Nov 2017
Decision
118d
Days
Class 2
Risk

K172124 is an FDA 510(k) clearance for the Televere Podiatry Digital Imaging System. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Televere Systems (Arnold, US). The FDA issued a Cleared decision on November 9, 2017 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - 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 Televere Systems devices

Submission Details

510(k) Number K172124 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2017
Decision Date November 09, 2017
Days to Decision 118 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
11d slower than avg
Panel avg: 107d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MQB Solid State X-ray Imager (flat Panel/digital Imager)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
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 Peers - MQB Solid State X-ray Imager (flat Panel/digital Imager)

All 219
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K172124.
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K163624 · Fujifilm Medical Systems U.S.A, Inc. · Jun 2017
1417WGC_127um and 1417WGC_140um
K171417 · Rayence Co., Ltd. · Jun 2017
1417WCC_127um and1417WCC_140um
K171418 · Rayence Co., Ltd. · Jun 2017