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Vitrea Version 7.0 Medical Image Processing Software

by Vital Images, Inc. 510(k)

Active United States

510(k) K150258

Overview

Vitrea Version 7.0 is a medical image processing software system designed for the processing, review, analysis, and communication of multi-dimensional digital images. It functions as a diagnostic tool within radiology, enabling radiologists to enhance, measure, and manipulate imaging data from various modalities such as CT, MRI, and ultrasound for improved diagnostic accuracy.

The software is supplied as a Class II X-ray system and is intended for use in radiology departments. It operates on standard computing platforms and requires no specific sterility or single-use considerations. Authorized for use in the United States under FDA 510(k) clearance (K150258), Vitrea Version 7.0 adheres to regulatory standards for medical imaging software, ensuring compliance with radiology workflow requirements.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK150258 Date5 Mar 2015ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

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

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Questions

  • What types of medical imaging data can Vitrea Version 7.0 process and analyze for diagnostic purposes?

    Vitrea Version 7.0 is designed to process, review, and analyze multi-dimensional digital images from various imaging modalities, including CT (computed tomography), MRI (magnetic resonance imaging), and ultrasound. This versatility allows radiologists to enhance, measure, and manipulate these images to improve diagnostic accuracy in radiology workflows.

  • How is Vitrea Version 7.0 supplied, and does it require any special handling like sterilization or single-use considerations?

    Vitrea Version 7.0 is supplied as a software system for use on standard computing platforms. Unlike physical medical devices, it does not require sterilization or single-use considerations. It is intended for installation on radiology department computers and operates as a diagnostic tool within that setting.

  • What regulatory pathway was followed for FDA clearance of Vitrea Version 7.0, and what does this mean for its use in the U.S.?

    Vitrea Version 7.0 received FDA clearance through a 510(k) submission (K150258) under the Special clearance type, determined to be substantially equivalent to a predicate device. This means the software meets regulatory standards for medical imaging software and is authorized for use in the United States as a Class II X-ray system within radiology departments.

  • Is Vitrea Version 7.0 compatible with any specific hardware, or can it be installed on standard radiology department computers?

    Vitrea Version 7.0 is designed to operate on standard computing platforms, meaning it can be installed on typical radiology department computers. No specialized hardware is required beyond a compatible system capable of running the software for processing and analyzing imaging data.