# K113620: Myrian 1.11

- Pathway: 510(k) (Traditional)
- Applicant: Intrasense
- Decided: Jul 12, 2012 after 218 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: 11 generations back to K913770 (1991). 163 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 170 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081985: AW Server, Ge Medical Systems, LLC (2008) Summary page 1.
- K061624: Vitrea, Version 3.9, Vital Images, Inc. (2006) Summary page 4.
- K082228: Planisight Linasys, Pathfinder Therapeutics, Inc. (2008) Summary page 1.
- K091001: Myrian 1.4, Intrasense (2009) Summary page 1.
- K093621: Syngo.Pet&CT Oncology, Siemens Medical Solutions USA, Inc. (2010) Summary page 1.
- K073194: Cmrtools and Plug-Ins Ventricular Tools & Thalassaemia Tools, Cardiovascular Imaging Solutions, Ltd. (2008) Summary page 1.

## Most influential descendants
- 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
- K220590: aPROMISE X (2022), 0 descendants of its own

## Indications for use
Myrian® is a software medical device aimed at reviewing images produced by all standard medical imaging devices. It also includes DICOM communication, media interchange (printing, CD burning, storing) and reporting features. Myrian® can be run from any standard client platform (such as PC) that might bf purchased independently by the end user. Common Users are trained medical professionals, including surgeons, radiologist clinicians and technicians. 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. Mainrographic 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/K113620
Methodology: https://510kreport.com/methodology