Visage Ease Pro
510(k) K142196
Active
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK142196 | Date28 Apr 2015 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
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, 18 Sep 2026
The Visage Ease Pro is a mobile imaging solution designed for radiology workflows, enabling flexible import and access of imaging data from various endpoints. Classified under product code LLZ, it integrates with existing systems to streamline diagnostic processes, supporting both order-based and encounter-based workflows.
This device is supplied as a software platform, intended for use in radiology departments and clinical settings where mobile imaging integration is required. It is not described as single-use or reusable, and no sterility or MRI safety information is provided in the specifications. The Visage Ease Pro holds FDA 510(k) clearance under K142196 and is compliant with the Medical Device Regulation (MDR).
From the manufacturer
Visage Ease™ Visage Ease Pro™ Work Flows With Ease Flexible, mobile imaging import and access that fits. Visage covers your bases. Whether your workflow is order-based, or encounter-based, Visage is ready.
Visage's signature innovation further accelerates with the launch of Visage Ease VP SAN DIEGO, CA, February 2, 2024 - Visage Imaging, Inc. ("Visage"), a wholly owned subsidiary of Pro Medicus Ltd. (ASX: PME), has announced the launch of the groundbreaking Visage Ease VP for Apple Vision Pro, Apple's highly anticipated spatial computing platform released today.
Questions
AI-generated answers, 18 Sep 2026
What types of clinical environments is the Visage Ease Pro designed to support within radiology workflows?
The Visage Ease Pro is specifically designed for radiology departments and clinical settings where mobile imaging integration is essential. It supports both order-based and encounter-based workflows, allowing flexible import and access to imaging data from various endpoints to streamline diagnostic processes.
How is the Visage Ease Pro supplied, and does it require any special handling like sterilization?
The Visage Ease Pro is supplied as a software platform, meaning it is not a physical device requiring sterilization or single-use/reuse considerations. Since it is software-based, no sterility or MRI safety information applies, and it operates independently of traditional medical device handling protocols.
What regulatory pathways has the Visage Ease Pro followed, and what does this mean for its use?
The Visage Ease Pro has obtained FDA 510(k) clearance under K142196, classified as substantially equivalent to a predicate device, and is compliant with the Medical Device Regulation (MDR). This means it has undergone regulatory review to ensure safety and effectiveness for its intended use in radiology workflows, adhering to both U.S. and EU standards.
Does the Visage Ease Pro integrate with existing hospital systems, and what kind of imaging data can it handle?
Yes, the Visage Ease Pro is designed to integrate with existing radiology systems, enabling flexible import and access to imaging data from multiple endpoints. While the exact formats aren’t specified, its purpose is to streamline workflows by consolidating diagnostic imaging data for easier review and analysis.