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Immerge Image Correlation

FDA 510(k)

Class II (US FDA 510(k))

510(k) K991468

by Surgical Navigation Technologies, Inc.

Identifiers

510(k) Number
K991468 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 ImMerge Image Correlation System is a software-based medical device designed for precise spatial registration of two distinct image sets. This enables accurate alignment of preoperative planning images, such as CT or MRI scans, with intraoperative imaging, including fluoroscopy or ultrasound. It is classified as a Class II X-ray system and supports surgical navigation by correlating imaging modalities for enhanced procedural guidance. The system facilitates real-time correlation, improving spatial awareness during complex interventions.

The device is supplied as a software solution and operates on compatible surgical navigation platforms. It is intended for single-use or multi-use depending on the host system’s configuration, with no explicit sterility requirements as it is non-invasive and does not contact the patient directly. The system is not MRI-safe for use within the scan room but may be used in adjacent areas where imaging data is processed. Authorized under FDA 510(k) clearance (K991468), it adheres to regulatory standards for X-ray-based surgical navigation systems and is distributed by Surgical Navigation Technologies, Inc.

Frequently asked questions

What is the ImMerge Image Correlation System used for?

The ImMerge Image Correlation System is a software-based medical device designed to align preoperative imaging (such as CT or MRI scans) with intraoperative imaging (like fluoroscopy or ultrasound) in real time. This precise spatial registration improves surgical navigation by enhancing the correlation between different imaging modalities, which helps clinicians maintain accurate spatial awareness during complex procedures.

How is the ImMerge Image Correlation System supplied and used?

The system is supplied as a software solution that operates on compatible surgical navigation platforms. It is not a standalone hardware device but integrates with existing systems to enable image correlation. Usage depends on the host system’s configuration—it can be configured for single-use or multi-use scenarios, though it does not require sterility as it does not contact the patient directly.

Is the ImMerge Image Correlation System sterile or reusable?

The ImMerge Image Correlation System is not sterile, as it is a non-invasive software solution that does not come into contact with patients. Its reuse or single-use status depends on the host system’s configuration, but it is designed for repeated use within approved surgical navigation platforms without requiring sterilization.

Can the ImMerge Image Correlation System be used in an MRI environment?

No, the ImMerge Image Correlation System is not MRI-safe for use within the MRI scan room. However, it can be utilized in adjacent areas where imaging data is processed and correlated, provided those areas are not within the MRI scan room itself.

What regulatory approval does the ImMerge Image Correlation System hold?

The ImMerge Image Correlation System holds FDA 510(k) clearance under the reference number K991468. This clearance confirms its substantial equivalence to a predicate device and compliance with regulatory standards for Class II X-ray-based surgical navigation systems.

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: Surgical Navigation Immerge Image Correlation - allmed.wiki, IMMERGE IMAGE CORRELATION (K970623) — FDA 510(k) | Innolitics, IMMERGE IMAGE CORRELATION (K991468) — FDA 510(k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Surgical Navigation Technologies, Inc.

Sources (1)

  • FDA 510(k) K991468 24 fields · synced Oct 1, 2026