Identifiers
- 510(k) Number
- K182624 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)
MIM SurePlan MRT Dosimetry is a software-based solution for Radiation Therapy Dosimetry (per FDA classification LLZ), designed to automate and standardize molecular radiotherapy (MRT) and theranostics dose planning and calculation. It integrates reconstruction and dose computation workflows to enhance precision in nuclear medicine treatments, ensuring consistent and efficient dosimetry processes.
The system is supplied as a standalone software application, intended for use in radiology departments and nuclear medicine settings. It operates on vendor-neutral platforms and does not require physical sterilization or single-use constraints, though its regulatory status is confirmed by FDA 510(k) clearance under K182624 (Traditional pathway, Substantially Equivalent). No specific MRI safety or sterility classifications are noted in the data.
Frequently asked questions
What clinical setting is this software designed for and how does it integrate into existing workflows?
MIM SurePlan MRT Dosimetry is specifically designed for use in radiology departments and nuclear medicine settings, where precision in molecular radiotherapy (MRT) and theranostics treatments is critical. It automates and standardizes dose planning and calculation workflows by integrating reconstruction and dose computation into a single platform. This reduces variability in dosimetry processes, ensuring consistency and efficiency without requiring physical hardware integration—it operates as a standalone software solution on vendor-neutral platforms.
Is this software single-use or reusable, and does it require sterilization?
MIM SurePlan MRT Dosimetry is a software-based solution, meaning it is neither single-use nor reusable in the traditional sense of physical devices. Since it runs on digital platforms, it does not require sterilization or disposal after use. Its regulatory clearance (FDA 510(k)) confirms its suitability for repeated use in clinical environments, provided the software itself remains updated and maintained per manufacturer guidelines.
What regulatory pathway was followed for this device’s clearance, and how does that affect its use?
The device was cleared via the FDA 510(k) Traditional pathway under K182624, determined to be Substantially Equivalent (SESE) to a predicate device in the Radiology category (product code LLZ). This means its safety and effectiveness were compared to an existing approved device, ensuring compliance with FDA standards for radiation therapy dosimetry software. Clinicians can rely on this clearance to confirm its regulatory validation for automating MRT dose planning in approved settings.
Does this software require any special storage conditions or environmental considerations?
As a software application, MIM SurePlan MRT Dosimetry does not have physical storage requirements like traditional medical devices. However, it must be installed on compatible, vendor-neutral platforms with adequate computational resources to support reconstruction and dose computation workflows. The system should be maintained in a secure, controlled environment to prevent unauthorized access or data breaches, adhering to standard IT security protocols for healthcare software.
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: MIM SurePlan MRT | Dosimetry for MRT and Theranostics ... - MIM Software, Practical Dosimetry | SurePlan MRT - MIM Software, Mim Software MRT Dosimetry - allmed.wiki
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K182624 | Class II | Active |
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Manufacturer
- Manufacturer
- Mim Software Inc.
- FDA Applicant
- Mim Software, Inc.
Sources (1)
- FDA 510(k) K182624 24 fields · synced Sep 20, 2026