Identifiers
- 510(k) Number
- K970623 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 is a software system that provides precise spatial registration of two image sets. It is a Class II X-ray system. The device is used for image correlation purposes.
The Immerge Image Correlation is supplied by Surgical Navigation Technologies, Inc. and has been issued FDA 510(k) clearances. The device has a product code of LLZ and is associated with the k number K970623. It is used in a radiology setting.
Frequently asked questions
What is the Immerge Image Correlation used for?
The Immerge Image Correlation is used for image correlation purposes in a radiology setting, providing precise spatial registration of two image sets.
How is the Immerge Image Correlation supplied?
The Immerge Image Correlation is supplied by Surgical Navigation Technologies, Inc.
What is the regulatory status of the Immerge Image Correlation?
The Immerge Image Correlation has been issued FDA 510(k) clearances, with a product code of LLZ and associated k number K970623.
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
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K970623 | Class II | Active |
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Manufacturer
- Manufacturer
- Surgical Navigation Technologies, Inc.
Sources (1)
- FDA 510(k) K970623 24 fields · synced Sep 28, 2026