Cleared Traditional

K170702 - mediCAD 4.0

K170702 is the FDA 510(k) clearance for mediCAD 4.0 by Medicad Hectec GmbH. It is a Class 2 Radiology device (product code LLZ) cleared through the Traditional 510(k) pathway after a 548-day FDA review.

K170702 · Medicad Hectec GmbH · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2018
Decision
548d
Days
Class 2
Risk

K170702 is an FDA 510(k) clearance for the mediCAD 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 Medicad Hectec GmbH (Altdorf, DE). The FDA issued a Cleared decision on September 7, 2018 after a review of 548 days - an unusually long review period, suggesting complex equivalence evaluation.

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 Medicad Hectec GmbH devices

Submission Details

510(k) Number K170702 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2017
Decision Date September 07, 2018
Days to Decision 548 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
441d slower than avg
Panel avg: 107d · This submission: 548d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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. 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 1056
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K170702.
OpenSight
K172418 · Novarad Corporation · Sep 2018
InVivo Web Viewer
K181926 · Anatomage, Inc. · Sep 2018
Volpara Imaging Software
K182310 · Volpara Health Technologies Limited · Sep 2018
syngo.via View&GO (Version VA10A)
K182208 · Siemens Healthcare GmbH · Sep 2018
Multi Modality Viewer
K182230 · Vital Images, Inc. · Sep 2018
AmCAD-UT Detection 2.2
K180006 · Amcad Biomed Corporation · Aug 2018