Cleared Special

K032346 - UNITY NETWORK IS PATIENT VIEWER

K032346 is an FDA 510(k) clearance for UNITY NETWORK IS PATIENT VIEWER, manufactured by Ge Medical Systems Information Technologies. The device is a Class 2 Cardiovascular device with product code MSX cleared through the Special 510(k) pathway after a 6-day FDA review.

K032346 · Ge Medical Systems Information Technologies · Cardiovascular device
Download Printable Device Report (PDF)
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Aug 2003
Decision
6d
Days
Class 2
Risk

K032346 is an FDA 510(k) clearance for the UNITY NETWORK IS PATIENT VIEWER. Classified as System, Network And Communication, Physiological Monitors (product code MSX), Class II - Special Controls.

Submitted by Ge Medical Systems Information Technologies (Milwaukee, US). The FDA issued a Cleared decision on August 5, 2003 after a review of 6 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - 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 Ge Medical Systems Information Technologies devices

FDA 510(k) Submission Details - K032346

510(k) Number K032346 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2003
Decision Date August 05, 2003
Days to Decision 6 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
119d faster than avg
Panel avg: 125d · This submission: 6d
Pathway characteristics
Modification to existing cleared device.

MSX Device Classification - Class 2, Special Controls

Product Code MSX System, Network And Communication, Physiological Monitors
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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 - MSX System, Network And Communication, Physiological Monitors

All 73
Devices cleared under the same product code (MSX) and FDA review panel - the closest regulatory comparables to K032346.
DATEX OHMEDA S/5 NETWORK AND CENTRAL (ICENTRAL) '03 WITH L-NET03 SOFTWARE
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K032582 · Ge Medical Systems Information Technologies · Sep 2003
INFINITY EXPLORER
K030615 · Siemens Medical Solutions USA, Inc. · Mar 2003
DATEX-OHMEDA S/5 WEB VIEWER WITH L-6WV02 SOFTWARE
K023497 · Datex-Ohmeda · Nov 2002
DATEX-OHMEDA S/5 NETWORK AND CENTRAL '02
K022507 · Datex-Ohmeda · Aug 2002