# K123519: Invivo  Dental

- Pathway: 510(k) (Traditional)
- Applicant: Anatomage, Inc.
- Decided: Feb 1, 2013 after 78 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: 6 generations back to K954678 (1996). 14 ancestors in all.
24 later devices descend from it; 5 cite it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070803: Invivodental, Anatomage, Inc. (2007) Summary page 2.
- K081347: Iluma Vision, Imtec Corp. (2008) Summary page 2.

## Most influential descendants
- K140713: Planmeca Romexis (2014), 14 descendants of its own
- 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

## Indications for use
InVivoDental is a software application used for the display and 3D visualization of medical image files from scanning devices, such as CT, MRT, or 3D Ultrasound. It is intended for use by radiologists, clinicians, referring physicians and other qualified individuals to retrieve, process, render, review, store, print, assist in diagnosis and distribute images, utilizing standard PC hardware. Additionally, InVivoDental is a preoperative software application used for the simulation and evaluation of dental implants, orthodontic planning and surgical treatments. This device is not indicated for mammography use.

Source page: https://510kreport.com/device/K123519
Methodology: https://510kreport.com/methodology