# K183412: mediCAD Web

- Pathway: 510(k) (Traditional)
- Applicant: Medicad Hectec GmbH
- Decided: Oct 31, 2019 after 325 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
mediCAD Web is a medical browser-based software, which allows professional orthopedics preoperative measurements of existing x-rays (2D) and CT (3D). The software is intended to read in diagnostic images (e.g. digitized x-rays) from PACS or conventional medias and to dimension them. An integrated database of orthopedic implant geometries can be overlayed to aid surgeons in their planning of orthopedic surgeries. mediCAD Web can hand over the digital plannings as DICOMs to PACS-systems. mediCAD will also support the proper workflow necessary to effectively compare pre- and post-operative radiograph studies for a unique understanding of the patient’s surgical outcome. Integrating this workflow with the orthopedic surgeons existing workflow and combining it with the data produced from the patient physical exam, provides a comprehensive data set for the continued prescription of a patient’s relevant treatment and therapy. The software is not for primary image interpretation. The software is not for use on mobile phones.

Source page: https://510kreport.com/device/K183412
Methodology: https://510kreport.com/methodology