Cleared Traditional

K060816 - MIM 4.0 (NEURO

K060816 is an FDA 510(k) clearance for MIM 4.0 (NEURO, manufactured by Mimvista Corp.. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K060816 · Mimvista Corp. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
50d
Days
Class 2
Risk

K060816 is an FDA 510(k) clearance for the MIM 4.0 (NEURO. 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 Mimvista Corp. (Cleveland, US). The FDA issued a Cleared decision on May 16, 2006 after a review of 50 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 - K060816

510(k) Number K060816 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 2006
Decision Date May 16, 2006
Days to Decision 50 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
57d faster than avg
Panel avg: 107d · This submission: 50d
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 2282
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K060816.
MEDICAL DISPLAY, MDC1900-1LG (1LR)
K061305 · Chi Lin Technology Co., Ltd. · May 2006
VOXAR 3D ENTERPRISE WITH CARDIAMETRIX
K061326 · Barcoview Mis Edinburgh · May 2006
3MATIC
K060950 · Materialise NV · May 2006
AQUARIUSAPS SERVER
K061214 · Terarecon,Inc. · May 2006
ACCUREX
K061126 · Cybermed, Inc. · May 2006
15-INCH (38CM) COLOR LCD MONITOR CDL1566A
K060961 · Totoku Electric Co., Ltd. · May 2006
K060816 · MIM 4.0 (NEURO
Download PDF FDA Summary Mimvista Corp.