# K140713: Planmeca Romexis

- Pathway: 510(k) (Traditional)
- Applicant: Planmeca Oy
- Decided: Jun 16, 2014 after 87 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). 19 ancestors in all.
14 later devices descend from it; 1 cites it directly.
0 of 34 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 2.
- K061035: Tigerview Professional, Televere Systems (2006) Summary page 2.

## Most influential descendants
- K162799: Cliniview (2017), 13 descendants of its own
- K203156: DTX Studio Clinic (2020), 10 descendants of its own
- K213562: DTX Studio Clinic 3.0 (2022), 9 descendants of its own
- K233925: Relu Creator (2024), 6 descendants of its own
- K243989: Second Opinion® 3D (2025), 3 descendants of its own

## Indications for use
Planmeca Romexis is a medical imaging software, and is 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 to retrieve, process, render, diagnose, review, store, print, and distribute images. It is also a preoperative software application used for the simulation and evaluation of dental implants. The software includes monitoring features for Planmeca devices for maintenance purposes. It 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. Planmeca Romexis software is: * Not intended for capturing optical impressions for dental restorations. * Not intended for optically scanning stone models and impressions for dental restorations. * Not intended for optically scanning intraoral preparations for use in designing implants and/or abutments. * Not intended for optically scanning intra-orally for use in orthodontics. * Not intended for mammography use.

Source page: https://510kreport.com/device/K140713
Methodology: https://510kreport.com/methodology