# K071964: Mim 4.1 (Seastar)

- Pathway: 510(k) (Traditional)
- Applicant: Mimvista Corp.
- Decided: Sep 26, 2007 after 72 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K954874 (1996). 46 ancestors in all.
287 later devices descend from it; 10 cite it directly.
1 of 334 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060816: Mim 4.0 (Neuro, Mimvista Corp. (2006) Summary page 1.
- K061006: Ikoengelo, Ikoetech, LLC (2006) Summary page 1.
- K043415: Centricity Pacs System, Ge Medical Systems Information Technologies (2005) Summary page 1.

## Most influential descendants
- K091373: Syngo Trued (2009), 200 descendants of its own
- K103576: Mim 5.2 (Brachy) (2011), 79 descendants of its own
- K101749: Syngo Trued Software (2010), 76 descendants of its own
- K101228: Mirada XD (2010), 70 descendants of its own
- K151913: MIM-Thin Client (mobile) (2016), 68 descendants of its own

## Recalls of this device
- Feb 19, 2025 · Class II · Z-1267-2025: 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
- Apr 23, 2008 · Not classified · Z-1827-2008: 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 follow

## Indications for use
MIM 4.1 (SEASTAR) software is used by trained medical professionals as a tool to aid in evaluation and information management of digital medical images. The medical image modalities include, but are not limited to, CT, MRI, CR, DX, MG, US, SPECT, PET and XA as supported by ACR/NEMA DICOM 3.0. MIM 4.1 (SEASTAR) assists in the following -indications: * Receive, transmit, store, retrieve, display, print, and process medical images and DICOM objects. * Create, display and print reports from medical images. * Registration, fusion display, and review of medical images for diagnosis, treatment evaluation, and treatment planning. * Evaluation of cardiac left ventricular function and perfusion, including left ventricular end-diastolic volume, end-systolic volume, and ejection fraction. * Localization and definition of objects such as tumors and normal tissues in medical images. * Creation, transformation, and modification of contours for applications including, but not limited to, quantitative analysis, aiding adaptive therapy, transferring contours to radiation therapy treatment planning systems, and archiving contours for patient follow-up and management. * Quantitative and statistical analysis of PET/SPECT brain scans by comparing to other registered PET/SPECT brain scans. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Images that are printed to film must be printed using a FDA-approved printer for the diagnosis of digital mammography images. Mammographic images must be viewed on a display system that has been cleared by the FDA for the diagnosis of digital mammography images. The software is not to be used for mammography CAD.

Source page: https://510kreport.com/device/K071964
Methodology: https://510kreport.com/methodology