Cleared Special

K073709 - MODIFICATION TO VIEWMATE SYSTEM

K073709 is an FDA 510(k) clearance for MODIFICATION TO VIEWMATE SYSTEM, manufactured by Ep Medsystems. The device is a Class 2 Radiology device with product code IYN cleared through the Special 510(k) pathway after a 71-day FDA review.

K073709 · Ep Medsystems · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2008
Decision
71d
Days
Class 2
Risk

K073709 is an FDA 510(k) clearance for the MODIFICATION TO VIEWMATE SYSTEM. Classified as System, Imaging, Pulsed Doppler, Ultrasonic within the IYN classification (a category covering pulsed Doppler and ultrasound imaging systems), Class II - Special Controls.

Submitted by Ep Medsystems (West Berlin, US). The FDA issued a Cleared decision on March 11, 2008 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1550 - 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.

View all Ep Medsystems devices

FDA 510(k) Submission Details - K073709

510(k) Number K073709 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 2007
Decision Date March 11, 2008
Days to Decision 71 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
36d faster than avg
Panel avg: 107d · This submission: 71d
Pathway characteristics
Modification to existing cleared device.

IYN Device Classification - Class 2, Special Controls

Product Code IYN System, Imaging, Pulsed Doppler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1550
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 - IYN System, Imaging, Pulsed Doppler, Ultrasonic

All 956
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K073709.
DC-3, DC-3T DIAGNOSTIC ULTRASOUND SYSTEM
K081320 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · May 2008
ACCUVIX V20 DIAGNOSTIC ULTRASOUND SYSTEM
K080800 · Medison Co., Ltd. · Apr 2008
M5 DIAGNOSTIC ULTRASOUND SYSTEM
K080640 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Mar 2008
ALOKA PROSOUND 6 DIAGNOSTIC ULTRASOUND SYSTEM
K080176 · Aloka Co., Ltd. · Feb 2008
APLIO ARTIDA, MODEL SSH-880CV DIAGNOSTIC ULTRASOUND SYSTEM
K080160 · Toshiba America Medical Systems, In.C · Feb 2008
GE LOGIQ P6
K073297 · General Electric Co. · Dec 2007