Cleared Special

K071028 - VIEWMATE SYSTEM

K071028 is an FDA 510(k) clearance for VIEWMATE SYSTEM, manufactured by Ep Medsystems. The device is a Class 1 Radiology device with product code ITN cleared through the Special 510(k) pathway after a 20-day FDA review.

K071028 · Ep Medsystems · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K071028

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 107d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

ITN Device Classification - Class 1, General Controls

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.

K071028 · VIEWMATE SYSTEM
Download PDF FDA Summary Ep Medsystems