Cleared Traditional

K051649 - VERICIS CARDIOVASCULAR IMAGE AND INFORMATION SYSTEM, MODEL 4.0

K051649 is an FDA 510(k) clearance for VERICIS CARDIOVASCULAR IMAGE AND INFORM..., manufactured by Camtronics Medical Systems. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K051649 · Camtronics Medical Systems · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2005
Decision
42d
Days
Class 2
Risk

K051649 is an FDA 510(k) clearance for the VERICIS CARDIOVASCULAR IMAGE AND INFORMATION SYSTEM, MODEL 4.0. 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 Camtronics Medical Systems (Hartland, US). The FDA issued a Cleared decision on August 2, 2005 after a review of 42 days - a notably fast clearance 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 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.

FDA 510(k) Submission Details - K051649

510(k) Number K051649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2005
Decision Date August 02, 2005
Days to Decision 42 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
65d faster than avg
Panel avg: 107d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LLZ Device Classification - Class 2, Special Controls

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. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - LLZ System, Image Processing, Radiological

All 2285
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K051649.
NIO 2MP-21
K051902 · Barcoview · Aug 2005
VIEWSEND MEDICAL SYSTEM
K051586 · Kenei Co., Ltd. · Aug 2005
AS-OBGYN INFORMATION SYSTEM
K051639 · As Software, Inc. · Aug 2005
STARPACS DENTAL
K051715 · Infinitt Co., Ltd. · Aug 2005
3TP WORKSPACE
K050862 · 3tp, LLC · Jul 2005
R2 BREAST IMAGING WORKSTATION
K051743 · R2 Technology, Inc. · Jul 2005
K051649 · VERICIS CARDIOVASCULAR IMAGE AND INFORMATION SYSTEM, MODEL 4.0
Download PDF FDA Summary Camtronics Medical Sy…