Imagefusion

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K960071 ↗

FDA Product Code

LLZ

Device Class

Class II

Regulation

21 CFR Part 892.2050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Optical Tracking System Microscope Module II, Model Ots Mmii

  Class II

  FDA 510(k) K990326 Active Cleared 4 Mar 1999

• Xknife-3

  Class II

  FDA 510(k) K953482 Active Cleared 25 Oct 1995

• Stereoplan

  Class II

  FDA 510(k) K946252 Active Cleared 14 Mar 1995

• Linac-Based Sterotactic Radiosurgery

  Class II

  FDA 510(k) K923522 Active Cleared 18 Aug 1993

• Optical Tracking System (Ots)

  Class II

  FDA 510(k) K964801 Active Cleared 2 Jun 1997

• Operating Arm System (OAS) With CT And MR Images

  Class II

  FDA 510(k) K961844 Active Cleared 23 Oct 1996

See all devices from Radionics Software Applications, Inc. →

• What is ImageFusion designed to do in medical imaging?

  ImageFusion is a radiological image processing system that integrates multiple imaging modalities—such as CT, MRI, and fluoroscopy—to overlay anatomical and functional data in real time. This enhances diagnostic accuracy by enabling clinicians to visualize cross-modal correlations, particularly useful in complex cases requiring detailed spatial alignment.

• How is ImageFusion supplied and intended for use?

  ImageFusion is supplied as standalone software for installation on compatible radiology workstations. It is intended for single-user, non-sterile applications within clinical or diagnostic imaging environments. No sterile packaging or single-use disposal is required, as it operates under traditional software licensing.

• Is ImageFusion reusable or single-use, and what are its storage requirements?

  ImageFusion is designed for reusable, multi-session use on licensed workstations. Since it is software-based and non-sterile, no specific storage requirements (e.g., temperature or humidity controls) are noted in regulatory documentation. Standard IT maintenance and system updates are recommended for optimal performance.

• What regulatory pathway was followed for ImageFusion’s clearance?

  ImageFusion received FDA clearance through a 510(k) submission (K960071) to the Radiology Advisory Committee, classified under the LLZ product code. The device was determined substantially equivalent to a predicate and falls under Class II regulatory controls, requiring compliance with special software-related requirements.

• Does ImageFusion have any special safety considerations for MRI environments?

  The regulatory data for ImageFusion does not specify an MRI safety classification or unique storage requirements tied to MRI compatibility. Clinicians should verify compatibility with their specific MRI system and follow standard radiology software safety protocols during use.