Cleared Special

K031148 - IN-VISION IMAGING SYSTEM

K031148 is an FDA 510(k) clearance for IN-VISION IMAGING SYSTEM, manufactured by Jomed, Inc.. The device is a Class 2 Cardiovascular device with product code DXK cleared through the Special 510(k) pathway after a 48-day FDA review.

K031148 · Jomed, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2003
Decision
48d
Days
Class 2
Risk

K031148 is an FDA 510(k) clearance for the IN-VISION IMAGING SYSTEM. Classified as Echocardiograph (product code DXK), Class II - Special Controls.

Submitted by Jomed, Inc. (Rancho Cordova,, US). The FDA issued a Cleared decision on May 28, 2003 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2330 - the FDA cardiovascular device 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 Jomed, Inc. devices

FDA 510(k) Submission Details - K031148

510(k) Number K031148 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2003
Decision Date May 28, 2003
Days to Decision 48 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 125d · This submission: 48d
Pathway characteristics
Modification to existing cleared device.

DXK Device Classification - Class 2, Special Controls

Product Code DXK Echocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2330
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DXK Echocardiograph

All 47
Devices cleared under the same product code (DXK) and FDA review panel - the closest regulatory comparables to K031148.
Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter
K181042 · Boston Scientific Corporation · May 2018
Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)
K160173 · Boston Scientific Corporation · Feb 2016
ACCESSORY TO GENESIS III (GCFM)
K913209 · Biosound, Inc. · May 1992
MODIFIED SYST: SONOS 500/1000 ULTRSOUND IMAG SYST
K904832 · Hewlett-Packard Co. · Apr 1991
PATIENT CARE MANAGEMENT SYSTEM MODIFICATION
K910029 · Spacelabs, Inc. · Jan 1991
INTERSPEC APOGEE
K903839 · Interspec, Inc. · Nov 1990