# K091001: Myrian 1.4

- Pathway: 510(k) (Traditional)
- Applicant: Intrasense
- Decided: Jun 29, 2009 after 82 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K913770 (1991). 44 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052995: Advantage Workstation 4.3., GE Healthcare (2005) Summary page 1.
- K061624: Vitrea, Version 3.9, Vital Images, Inc. (2006) Summary page 1.
- K082228: Planisight Linasys, Pathfinder Therapeutics, Inc. (2008) Summary page 1.
- K071000: Myrian, Intrasense (2007) Summary page 1.

## Most influential descendants
- K113620: Myrian 1.11 (2012), 6 descendants of its own
- K160334: Advanced Medical Imaging Software Suite (KSWVWR) (2016), 2 descendants of its own
- K130552: CT Pulmonary Analysis (2014), 2 descendants of its own
- K211655: aPROMISE (2021), 1 descendant of its own
- K181892: Ziostation2 (2018), 1 descendant of its own

## Indications for use
Myrian is a multi modality medical diagnostic device. It is aimed at reviewing and analyzing anatomy and pathology. It also includes DICOM communication capabilities and media interchange features (printing, CD burning, storing). It runs on any standard PC including laptops that might be purchased independently by the end user, It provides user a set of tools meant to create and modify objects of interest: points of interest, annotations of interest and volumes of interest. This device is not indicated for mammography use. Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA.

Source page: https://510kreport.com/device/K091001
Methodology: https://510kreport.com/methodology