Cleared Special

K071028 - VIEWMATE SYSTEM (FDA 510(k) Clearance)

Class I Radiology device.

K071028 · Ep Medsystems · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2007
Decision
20d
Days
Class 1
Risk

K071028 is an FDA 510(k) clearance for the VIEWMATE SYSTEM. Classified as Splint, Denis Brown (product code ITN), Class I - General Controls.

Submitted by Ep Medsystems (West Berlin, US). The FDA issued a Cleared decision on May 1, 2007 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 890.3675 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

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Submission Details

510(k) Number K071028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 2007
Decision Date May 01, 2007
Days to Decision 20 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 107d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code ITN Splint, Denis Brown
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3675
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.