Cleared Traditional

K052424 - MAXILIM

K052424 is an FDA 510(k) clearance for MAXILIM, manufactured by Medicim NV. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K052424 · Medicim NV · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2006
Decision
210d
Days
Class 2
Risk

K052424 is an FDA 510(k) clearance for the MAXILIM. 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 Medicim NV (Shelton, US). The FDA issued a Cleared decision on March 31, 2006 after a review of 210 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.

FDA 510(k) Submission Details - K052424

510(k) Number K052424 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 2005
Decision Date March 31, 2006
Days to Decision 210 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
103d slower than avg
Panel avg: 107d · This submission: 210d
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 2284
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K052424.
MONOCHROME LCD MONITOR, RADIFORCE MODEL GS310
K060845 · Eizo Nanao Corporation · Apr 2006
CAAS MRV VERSION 3.0
K060941 · Pie Medical Imaging BV · Apr 2006
SVIEW
K060840 · Mri Cardiac Services, Incorporated · Apr 2006
VOXAR 3D ENTERPRISE, MODEL 6.1
K060505 · Barcoview Mis Edinburgh · Mar 2006
M-VU VIEWER STATION
K060451 · Vucomp, Inc. · Mar 2006
VIRTUAL IMPLANT PLACEMENT (VIP) DENTAL IMPLANT SURGERY PLANNING SOFTWARE
K060267 · Implant Logic Systems, Ltd. · Mar 2006
K052424 · MAXILIM
Download PDF FDA Summary Medicim NV