Cleared Traditional

K121762 - CARDIAC VX

K121762 is the FDA 510(k) clearance for CARDIAC VX by Ge Medical Systems, LLC. It is a Class 2 Radiology device (product code LLZ) cleared through the Traditional 510(k) pathway after a 217-day FDA review.

K121762 · Ge Medical Systems, LLC · Radiology device
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Jan 2013
Decision
217d
Days
Class 2
Risk

K121762 is an FDA 510(k) clearance for the CARDIAC VX. Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by Ge Medical Systems, LLC (Waukesha, US). The FDA issued a Cleared decision on January 18, 2013 after a review of 217 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - 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: Incremental AI imaging tool. Moderate-to-high equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Ge Medical Systems, LLC devices

Submission Details

510(k) Number K121762 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2012
Decision Date January 18, 2013
Days to Decision 217 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
110d slower than avg
Panel avg: 107d · This submission: 217d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Radiology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT00877903 Completed Interventional Industry-sponsored

Prochymal® (Human Adult Stem Cells) Intravenous Infusion Following Acute Myocardial Infarction (AMI)

A Phase II, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of PROCHYMAL® (Ex Vivo Cultured Adult Human Mesenchymal Stem Cells) Intravenous Infusion Following Acute Myocardial Infarction

220
Patients (actual)
33
Sites
Treatment
Purpose
Quadruple
Masking
Condition studied Myocardial Infarction
Study design Parallel
Eligibility All sexes · 21 Years+
Principal investigator Ken Borow, MD
Sponsor Mesoblast, Inc. (industry)
Started 2009-03-30 → Primary completion 2011-05-18 → Completed 2016-03-14
Primary outcome
Change from Baseline in Cardiac Magnetic Resonance (CMR) imaging-determined End Systolic Volume (ESV) at Month 3
Secondary outcome
Left Ventricular End Systolic Volume
Study completed - no results published. This trial concluded in 2016 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

Regulatory Peers - LLZ System, Image Processing, Radiological

All 1127
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K121762.
SYNGO, BREAST CARE
K123420 · Siemens Medical Solutions USA, Inc. · Feb 2013
SYNAPSE 3D COLON ANALYSIS
K123566 · Fujifilm Medical Systems U.S.A, Inc. · Jan 2013
SYNGO.VIA MI WORKFLOWS
K123577 · Siemens Medical Solutions USA, Inc. · Jan 2013
SYNGO.VIA
K123920 · Siemens AG Medical Solutions · Jan 2013
SYNGO DYNAMICS
K123922 · Siemens Medical Solutions USA, Inc. · Jan 2013
INTERVENTIONAL WORKSPOT
K121296 · Philips Medical Systems Nederland B.V. · Jan 2013