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Atomica Planner

FDA 510(k)

Class II (US FDA 510(k))

510(k) K230012

by Atomica Technology, Inc.

Identifiers

510(k) Number
K230012 FDA 510(k)
FDA Product Code
LLZ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.2050 FDA 510(k)
Regulation Number
892.2050 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Atomica Planner is a radiological image processing system designed for advanced planning and analysis in dental and maxillofacial radiology. It falls under the classification of image processing systems, specifically tailored for use in radiology procedures, enabling precise visualization and treatment planning for dental implants and surgical interventions. This software-based solution integrates with Picture Archiving and Communication Systems (PACS) to enhance diagnostic accuracy and procedural outcomes.

The device is supplied as a software application, intended for use in radiology settings by qualified professionals with expertise in implantology and surgical planning. It is cleared for single-use or multi-use within its intended software environment, with no specific sterility requirements as it operates digitally. The Atomica Planner holds an FDA 510(k) clearance under K-number K230012, classified under product code LLZ, and is intended for use in radiology departments. No MRI safety or physical size specifications are noted in the regulatory data.

Frequently asked questions

What is the Atomica Planner used for in dental radiology?

The Atomica Planner is a software-based radiological image processing system designed specifically for advanced planning and analysis in dental and maxillofacial radiology. It enables precise visualization and treatment planning for dental implants and surgical interventions, improving diagnostic accuracy and procedural outcomes by integrating with Picture Archiving and Communication Systems (PACS).

How is the Atomica Planner supplied and what are its sterility requirements?

The Atomica Planner is supplied exclusively as a software application, intended for use in radiology settings by qualified professionals with expertise in implantology and surgical planning. Since it operates digitally, there are no physical sterility requirements—it is not a sterile device and does not require sterilization procedures.

Is the Atomica Planner intended for single-use or multi-use?

The Atomica Planner is cleared for use within its intended software environment, allowing for multi-use as long as it remains within that digital environment. Unlike physical devices, its software-based nature does not impose limitations on reuse, provided it adheres to manufacturer guidelines for updates and maintenance.

Does the Atomica Planner have any physical size or MRI safety specifications?

The regulatory data for the Atomica Planner does not include any physical size specifications or MRI safety considerations, as it is a software-only solution. Its functionality relies entirely on digital processing and integration with existing radiology infrastructure, such as PACS, without requiring physical hardware or proximity to MRI environments.

What regulatory clearance does the Atomica Planner hold, and how was it classified?

The Atomica Planner holds an FDA 510(k) clearance under K-number K230012, classified under product code LLZ. It was determined to be substantially equivalent to a predicate device through a traditional review process by the Radiology Advisory Committee (RA). This clearance confirms its compliance with U.S. regulatory standards for image processing systems in radiology.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K230012 FDA 510(k) - Atomica Planner | Atomica Technology, Inc., Atomica Planner - allmed.wiki, Atomica Planner (K230012) — FDA 510 (k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Atomica Technology, Inc.

Sources (1)

  • FDA 510(k) K230012 24 fields · synced Oct 1, 2026