Metavision Clinical Information System

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

Trade Name

MetaVision

Model / Reference

6.x, 6.20 and up

Primary DI / UDI-DI

00007290116893

Basic UDI-DI

729011689MetaVisionX6

510(k) Number

K012349 ↗

FDA Product Code

MWI

EMDN Code

V92 Medical device software - not included in other classes

Device Class

Class IIb EUDAMED

Class II 510(k)

Regulation

21 CFR Part 870.2300

Special Device Type

Software

EU market of registration

Netherlands

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• MetaVision

  Class IIa

  CE/MDD

• What types of clinical settings is the Metavision Clinical Information System designed to support?

  The Metavision Clinical Information System is specifically designed for regulated healthcare environments like hospitals and cardiac catheterization labs. It integrates with existing workflows to manage, analyze, and visualize data related to cardiovascular procedures and interventions, ensuring seamless support for diagnostic and treatment processes in these specialized settings.

• How is the Metavision Clinical Information System supplied, and does it require sterilization?

  The Metavision Clinical Information System is supplied as a software solution, meaning it runs on compatible computing hardware rather than as a physical device. Since it is a digital tool, it does not require physical sterilization. It is intended for reusable use in clinical environments, eliminating the need for sterilization processes.

• What regulatory pathways has the Metavision Clinical Information System followed, and what does this mean for its use?

  The Metavision Clinical Information System has obtained FDA 510(k) clearance through the Traditional pathway, with a decision date of January 29, 2002. It also complies with the EU Medical Device Directives (MDD) and the Medical Device Regulation (MDR). This means the device has undergone evaluation to ensure its safety and effectiveness for managing cardiovascular clinical data in regulated healthcare settings, adhering to both U.S. and EU standards.

• Is the Metavision Clinical Information System intended for single-use or reusable applications?

  The Metavision Clinical Information System is designed as a reusable digital tool. Since it operates as software on compatible hardware, it does not have a physical form that would require single-use disposal. Instead, it is meant to be utilized repeatedly across multiple clinical procedures and interventions in cardiovascular settings.

• What kind of cardiovascular procedures or interventions does the Metavision Clinical Information System support?

  While the device is classified under product code MWI for cardiovascular applications, the exact procedures or interventions it supports are not explicitly detailed in the provided data. However, it is intended to manage, analyze, and visualize clinical data related to cardiac procedures and interventions, which would include workflows for diagnostic imaging, catheterization, and other cardiovascular treatments in clinical settings.