# K171385: Planmeca Romexis

- Pathway: 510(k) (Traditional)
- Applicant: Planmeca Oy
- Decided: Nov 14, 2017 after 187 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
Longest line of descent: 7 generations back to K954678 (1996). 15 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123519: Invivo  Dental, Anatomage, Inc. (2013) Summary page 5.

## Most influential descendants
- K192165: Acteon Imaging Suite (2020), 0 descendants of its own

## Indications for use
Planmeca Romexis is a medical imaging software intended for use in dental and medical care as a tool for displaying and visualizing dental and medical 2D and 3D image files from imaging devices, such as projection radiography and CBCT. It is intended for use by radiologists, clinicians, referring physicians and other qualified individuals to retrieve, process, render, diagnose, review, store, print, and distribute images of both adult and pediatric patients. Planmeca Romexis is also a preoperative software application used for dental implant planning. Based on the planned implant position a model of a surgical guide for a guided implant surgery can be designed, The designed data can be exported to manufacture a separate physical product. Additionally, Planmeca Romexis includes monitoring features for Planmeca devices for maintenance purposes. The software is designed to work as a stand-alone or as an accessory to Planmeca imaging and Planmeca dental unit products in a standard PC. The software is for use by authorized healthcare professionals. Use of the software for implant planning requires that the user has the necessary medical training in implantology and surgical dentistry. Indications of the dental implants do not change with guided surgery compared to conventional surgery. Planmeca Romexis is also intended to be used for monitoring, recording, storing and displaying mandibular jaw positions and movements relative to the maxilla. This device is not indicated for mammography use.

Source page: https://510kreport.com/device/K171385
Methodology: https://510kreport.com/methodology