# K120734: Microsoft Amalga Uis Image Processing Module

- Pathway: 510(k) (Traditional)
- Applicant: Microsoft Corp.
- Decided: Aug 2, 2012 after 146 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: 7 generations back to K913770 (1991). 31 ancestors in all.
No later device cites it as a predicate yet.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061214: Aquariusaps Server, Terarecon,Inc. (2006) Summary page 3.
- K011142: Aquarius Workstation, Terarecon,Inc. (2001) Summary page 3.

## Indications for use
The Microsoft® Amalga™ UIS Image Processing Module (IPM) is used in conjunction with Microsoft® Amalga™ UIS and Microsoft® Amalga™ UIS Medical Imaging Module to receive medical images from acquisition devices and imaging systems adhering to DICOM protocol. Medical images received from volumetric or planar imaging modalities are processed to derive certain information. The information thus derived is transmitted using the DICOM or HTTP protocol to other devices supporting these standard protocols. The IPM enables physicians and other healthcare providers to rapidly navigate across images by selecting tagged organs and review them through multi-planar reconstruction (MPR). IPM is not intended to be used for primary diagnosis. This device is not intended to be used for mammography.

Source page: https://510kreport.com/device/K120734
Methodology: https://510kreport.com/methodology