# K071636: Codiagnostix (R) 5.72

- Pathway: 510(k) (Abbreviated)
- Applicant: Ivs Solutions AG
- Decided: Aug 9, 2007 after 55 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K954678 (1996). 9 ancestors in all.
21 later devices descend from it; 2 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033849: Simplant System, Materialise NV (2004) Summary page 1.
- K053155: Vimplant, Cybermed, Inc. (2005) Summary page 1.

## Most influential descendants
- K130724: Codiagnostix Implant Planning Software (2013), 15 descendants of its own
- K141570: Implant Studio (2014), 8 descendants of its own
- K152078: Implant Studio 2015 (2015), 7 descendants of its own
- K112251: Swissmeda Dental Planning System (2012), 4 descendants of its own
- K123976: Nobelclinician (2013), 3 descendants of its own

## Recalls of this device
- Aug 4, 2011 · Not classified · Z-3184-2011: Software version 8.0 has a software anomaly, in which the length is not adjusted accordingly when it is changed after the surgical sleeve position planning step has been completed.
- Sep 30, 2010 · Not classified · Z-1592-2011: Software: Surgical Error may occur when the implant length is changed after positioning the surgical sleeve.

## Indications for use
coDiagnostiX® is intended for use by medical trained people as a Windows®- based diagnosis and implant planning software. This software is an interface for the transfer of imaging information from medical scanners such as CT or DVT scanners and also a pre- operative software for simulation and evaluation dental implant placement and surgical treatment options. The patient population will be the general public. coDiagnostiX® is not intended to be used in direct contact with the patient nor is it intended to be used with life sustaining devices. It's possible to use coDiagnostiX® as a pattern for manufacturing drilling templates with conventional rotary tables or the gonyX® table from IVS Solutions AG in laboratory environment. This drilling template is then used in direct contact with the patient to realize the implant planning with coDiagnostiX®.

Source page: https://510kreport.com/device/K071636
Methodology: https://510kreport.com/methodology