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MIM 4.1 (Seastar)

by Mimvista Corp.

510(k) K071964

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK071964 Date26 Sep 2007ClearedStatusActive

Recalls

2 recalls · 1 ongoing · FDA

    • Ongoing Z-1267-2025 FDA Class II initiated 19 Feb 2025

    In situations where two images with differing Fields of View (FOV) complete an image fusion, an incorrect, elevated Maximum Standardized Uptake Value (SUV) within MIM Software versions 7.2.0 through 7.2.6.could result.

    • Terminated Z-1827-2008 FDA Unclassified (pre-2012) initiated 23 Apr 2008

    In MIM (4.0.2-4.0.5) and MIM (4.1.0-4.1.2) versions, there is an error that may occur during the calculation of statistics using the SUV Tool or Contour Statistics. It will occur only under the following specific circumstance: A fusion of a primary volume which has a Z-Axis slice separation larger than that of the secondary volume and statistics are reported on the secondary volume.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

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

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The MIM 4.1 (Seastar) is a Picture Archiving and Communication System (PACS), classified under 21 CFR 892.2050 as a Class II medical device. It is designed to store, retrieve, distribute, and display digital medical images and associated information from various modalities, including X-ray, CT, MRI, and ultrasound, enabling efficient radiology workflows and diagnostic processes. This system facilitates integration with existing imaging equipment and supports advanced imaging analysis tools for clinical decision-making. Its architecture ensures compatibility with enterprise-wide networks, enhancing interoperability across healthcare settings.

The MIM 4.1 (Seastar) is supplied as a software-based solution, installed on dedicated hardware or integrated into existing IT infrastructure within radiology departments or hospital networks. It operates in a non-sterile environment and is intended for reusable deployment, requiring periodic software updates and system maintenance. The device adheres to MRI safety standards for its designated operating environment, though specific compatibility details are governed by the manufacturer’s technical documentation. Authorized under FDA 510(k) clearance (K071964), it is regulated as a Class II device under the Radiology advisory committee, with no third-party involvement in its approval process.

Other devices from Mimvista Corp.

  • Mim 3.5 (Circa)

    Class II

  • Mim 4.0 (Neuro

    Class II

  • Mimviewer

    Class II

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the MIM 4.1 (Seastar) designed for?

    The MIM 4.1 (Seastar) is a Picture Archiving and Communication System (PACS) designed to store, retrieve, distribute, and display digital medical images and associated information from various imaging modalities, including X-ray, CT, MRI, and ultrasound. It enhances radiology workflows by enabling efficient image management and supporting advanced imaging analysis tools for better clinical decision-making.

  • How is the MIM 4.1 (Seastar) supplied and deployed?

    The MIM 4.1 (Seastar) is supplied as a software-based solution that can be installed on dedicated hardware or integrated into existing IT infrastructure within radiology departments or hospital networks. It is intended for reusable deployment, requiring periodic software updates and system maintenance to ensure optimal performance.

  • Is the MIM 4.1 (Seastar) sterile or non-sterile?

    The MIM 4.1 (Seastar) operates in a non-sterile environment. Since it is a software-based system installed on hardware or integrated into IT infrastructure, sterility is not applicable. The device is designed for use in clinical settings where sterility is not a requirement.

  • What are the key regulatory details for the MIM 4.1 (Seastar)?

    The MIM 4.1 (Seastar) is classified under 21 CFR 892.2050 as a Class II medical device and has received FDA 510(k) clearance (K071964). It was determined to be substantially equivalent to a predicate device and is regulated under the Radiology advisory committee. The device does not involve third-party involvement in its approval process.

  • Does the MIM 4.1 (Seastar) support MRI safety standards?

    The MIM 4.1 (Seastar) adheres to MRI safety standards for its designated operating environment. However, specific compatibility details for MRI safety are governed by the manufacturer’s technical documentation, which should be consulted for precise guidelines on use in MRI environments.