Longitudinal Brain Imaging (LoBI) Application
by Philips Medical Systems Nederland B.V.
510(k) K163250
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK163250 | Date11 May 2017 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LLZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Longitudinal Brain Imaging (LoBI) Application is a post-processing software tool designed for analyzing and visualizing brain MRI images over time. It facilitates the assessment of subtle neurological changes by enabling comparative analysis across multiple scans, using techniques such as bias field correction, intensity scaling, and image registration. The application generates color-coded overlays to highlight variations between longitudinal imaging sessions, aiding in the evaluation of disease progression or treatment response in neurological conditions.
This application is supplied as a digital software module for use with MRI diagnostic systems and is intended for single-use per imaging session. It operates within an MRI-compatible environment and does not require sterilization. The device is regulated under FDA 510(k) clearance (K163250) and falls under the product code LLZ, classified under the Radiology Advisory Committee. No additional storage or handling restrictions are specified beyond standard MRI system requirements.
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Questions
AI-generated answers, 1 Oct 2026
What is the LoBI Application used for?
The LoBI Application is a post-processing software tool designed specifically for analyzing and visualizing brain MRI scans over time. It helps clinicians assess subtle neurological changes by comparing multiple scans through techniques like bias field correction, intensity scaling, and image registration. The application highlights variations between sessions with color-coded overlays, making it ideal for monitoring disease progression or treatment response in neurological conditions.
How is the LoBI Application supplied and used?
The LoBI Application is supplied as a digital software module intended for use with MRI diagnostic systems. It is intended for single-use per imaging session, meaning each session requires a fresh instance of the application. Since it operates within an MRI-compatible environment, no additional hardware or sterilization is required—it simply integrates with existing MRI workflows.
Does the LoBI Application require sterilization or special storage?
No, the LoBI Application does not require sterilization as it is a digital software tool. It operates within an MRI-compatible environment, so no additional storage restrictions apply beyond adhering to standard MRI system requirements. Ensure the software is installed on a system that meets the manufacturer’s technical specifications for optimal performance.
Is the LoBI Application reusable across multiple sessions?
No, the LoBI Application is designed for single-use per imaging session. Each session requires a new instance of the application to ensure accurate comparative analysis of brain MRI scans over time. This design prevents data corruption or interference between different longitudinal studies.
What regulatory approval does the LoBI Application hold?
The LoBI Application holds FDA 510(k) clearance under the product code LLZ, classified under the Radiology Advisory Committee. This clearance indicates the device is deemed substantially equivalent to a legally marketed predicate device, ensuring it meets regulatory standards for safety and effectiveness in its intended use.