Who is the manufacturer of IMMERGE IMAGE CORRELATION?

Surgical Navigation Technologies, Inc. filed the 510(k) submission for IMMERGE IMAGE CORRELATION (K970623).

What is the FDA product code for IMMERGE IMAGE CORRELATION?

LLZ. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for IMMERGE IMAGE CORRELATION?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like IMMERGE IMAGE CORRELATION?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

IMMERGE IMAGE CORRELATION

K970623 · Surgical Navigation Technologies, Inc. · LLZ · Apr 28, 1997 · Radiology

Device Facts

Record ID	K970623
Device Name	IMMERGE IMAGE CORRELATION
Applicant	Surgical Navigation Technologies, Inc.
Product Code	LLZ · Radiology
Decision Date	Apr 28, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	Software as a Medical Device

Intended Use

This submission describes a software system that provides precise spatial registration of two image sets for the purpose of enhancing the imaging information presented to a physician. The resulting image sets can then be used for diagnosis and planning treatments such as image guided surgery, stereotactic radiosurgery, or radiotherapy.

Device Story

Software system; performs spatial registration of two image sets; enhances imaging information for physician review. Used in clinical settings for diagnosis and treatment planning; supports image-guided surgery, stereotactic radiosurgery, and radiotherapy. Physician operates system to correlate images; output used to inform surgical or therapeutic planning. Benefits include improved visualization and spatial accuracy for clinical decision-making.

Technological Characteristics

Software-based image correlation system; performs spatial registration of image data sets.

Indications for Use

Indicated for physicians requiring spatial registration of two image sets to enhance imaging information for diagnosis and treatment planning, including image-guided surgery, stereotactic radiosurgery, and radiotherapy.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Related Devices

K991468 — IMMERGE IMAGE CORRELATION · Surgical Navigation Technologies, Inc. · Jul 6, 1999
K170816 — Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature Correction, Elements TRAM · Brainlab AG · Sep 26, 2017
K190042 — Brainlab Elements Image Fusion Angio · Brainlab AG · Apr 25, 2019
K990071 — IMAGEFUSION 2.0 · Radionics, Inc. · Feb 8, 1999
K960071 — IMAGEFUSION · Radionics Software Applications, Inc. · Apr 17, 1996

Submission Summary (Full Text)

{0} K970623 # APR 28 1997 ## Summary of Safety and Effectiveness ### ImMerge™ Image Correlation System I. **Company:** Surgical Navigation Technologies 530 Compton St. Broomfield, CO 80020 (303) 439-9709 II. **Product Name:** ImMerge™ Image Correlation System III. This submission describes a software system that provides precise spatial registration of two image sets for the purpose of enhancing the imaging information presented to a physician. The resulting image sets can then be used for diagnosis and planning treatments such as image guided surgery, stereotactic radiosurgery, or radiotherapy. IV. The ImMerge™ Image Correlation System was shown to be substantially equivalent to other commercially available image correlation systems. Evidence of the substantial equivalence was provided.