Cleared Traditional

K110746 - 4D LV-ANALYSIS 3.0

K110746 is an FDA 510(k) clearance for 4D LV-ANALYSIS 3.0, manufactured by Tomtec Imaging Systems GmbH. The device is a Class 2 Radiology device with product code DQK cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K110746 · Tomtec Imaging Systems GmbH · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2011
Decision
68d
Days
Class 2
Risk

K110746 is an FDA 510(k) clearance for the 4D LV-ANALYSIS 3.0. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Tomtec Imaging Systems GmbH (Unterschleissheim, DE). The FDA issued a Cleared decision on May 24, 2011 after a review of 68 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 870.1425 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Tomtec Imaging Systems GmbH devices

FDA 510(k) Submission Details - K110746

510(k) Number K110746 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2011
Decision Date May 24, 2011
Days to Decision 68 days
Submission Type Traditional
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
39d faster than avg
Panel avg: 107d · This submission: 68d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQK Device Classification - Class 2, Special Controls

Product Code DQK Computer, Diagnostic, Programmable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1425
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 - DQK Computer, Diagnostic, Programmable

All 370
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K110746.
RHYTHMVIEW (TM)
K110878 · Topera, Inc. · Sep 2011
SPACELABS PATHFINDER SL HOLTER ANALYZER
K110001 · Spacelabs Healthcare, Ltd. · Jun 2011
MUSE CARDIOLOGY INFORMATION SYSTEM
K110132 · Ge Medical Systems Information Technologies, Inc. · May 2011
ENSITE VELOCITY SYSTEM
K110549 · St Jude Medical · May 2011
SPACELABS SMART DISCLOSURE SYSTEM
K110779 · Spacelabs Healthcare · Apr 2011
CASE CARDIAC TESTING SYSTEM, CS CARDIAC TESTING SYSTEM
K103678 · Ge Medical Systems Information Technologies GmbH · Feb 2011