Skip to content

Codiagnostix 5.72

by Ivs Solutions AG

510(k) K071636

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Abbreviated NumberK071636 Date9 Aug 2007ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-3184-2011 FDA Unclassified (pre-2012) initiated 4 Aug 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.

    • Terminated Z-1592-2011 FDA Unclassified (pre-2012) initiated 30 Sep 2010

    Software: Surgical Error may occur when the implant length is changed after positioning the surgical sleeve.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Codiagnostix (R) 5.72
510(k) Number
FDA Product Code
LLZ
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Codiagnostix 5.72 is a radiological image processing system designed for generating three-dimensional datasets. It facilitates precise, image-guided preoperative planning for dental implant procedures, ensuring reproducible and accurate surgical outcomes.

This device is supplied as a software-based system and is intended for use in clinical radiology settings. It has received FDA 510(k) clearance under the product code LLZ, with a decision classification of Substantially Equivalent (SESE) in the Radiology specialty. The system is not described as single-use or reusable, nor are MRI safety or sterility specifications provided in the available data.

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What clinical setting is the Codiagnostix 5.72 intended for, and how does it improve surgical outcomes in dental procedures?

    The Codiagnostix 5.72 is designed for use in clinical radiology settings, specifically to generate three-dimensional datasets from imaging data. It aids in precise, image-guided preoperative planning for dental implant procedures, ensuring reproducible and accurate surgical outcomes by enhancing surgical precision through detailed 3D visualization.

  • Is the Codiagnostix 5.72 a standalone software solution, and how is it supplied to users?

    Yes, the Codiagnostix 5.72 is a software-based system, meaning it does not require physical hardware beyond a compatible computer or radiology workstation. It is supplied as a digital solution for integration into existing clinical radiology workflows, allowing users to process imaging data for dental implant planning.

  • What regulatory pathway was followed for FDA clearance of the Codiagnostix 5.72, and what does the product code LLZ indicate?

    The Codiagnostix 5.72 received FDA clearance through an abbreviated 510(k) process, classified as *Substantially Equivalent (SESE)* under product code LLZ, which falls under the Radiology specialty. This classification indicates the device was deemed comparable to a legally marketed predicate device in terms of technological characteristics.

  • Can the Codiagnostix 5.72 be reused across multiple patients, or is it intended for single-use?

    The available data does not specify reuse or single-use restrictions for the Codiagnostix 5.72, as it is a software-based system. Since it operates digitally and does not involve consumable or disposable components, its usability depends on system maintenance and compliance with institutional IT policies rather than per-patient constraints.

  • How can I verify the manufacturer’s contact details for support or inquiries regarding the Codiagnostix 5.72?

    For support or inquiries, you can contact Ivs Solutions AG at their registered address: *Annaberget Strasse 240, Chemnitz, Saxony, 09125, Germany*. The contact person listed is FRANK STOCKMANN, though you may also verify current contact details directly through the manufacturer’s official website or customer service channels.