510(k) · Cleared
ClearedMicrosoft Amalga Uis Image Processing Module
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microsoft Corp. · LLZ System, Image Processing, Radiological
Cleared on Aug 2, 2012 as substantially equivalent to K061214 (Terarecon,Inc., 2006) and 1 other predicate after a 146-day review. Its family tree reaches back 7 generations to 1991.
- Decided
- Aug 2, 2012
- Review
- 146 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K913770 (1991). 31 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 6 generations backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- 5 generations backK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- 4 generations backK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- 3 generations backK033374 Lungcare CT Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2003
- 2 generations backK041807 Lung Car 1.1Medicsight · 2004
- 1 generation backK061214 Aquariusaps ServerTerarecon,Inc. · 2006
- This deviceK120734 Microsoft Amalga Uis Image Processing ModuleMicrosoft Corp. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −6 | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| −5 | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| −4 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −3 | K033374 | Lungcare CT Software Package with Extended Functionality | Siemens AG Medical Solutions | 2003 | — |
| −2 | K041807 | Lung Car 1.1 | Medicsight | 2004 | — |
| −1 | K061214 | Aquariusaps Server | Terarecon,Inc. | 2006 | — |
| 0 (this device) | K120734 | Microsoft Amalga Uis Image Processing Module | Microsoft Corp. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 6 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LLZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K061214 | Aquariusaps ServerSummary page 3…ariusAPS Workstation 510(k) Number K061214 K011142 Product Code LLZ LIZ LIZ Regulation Number… | 2006 |
| * | K011142 | Aquarius WorkstationSummary page 3…Workstation 510(k) Number K061214 K011142 Product Code LLZ LIZ LIZ Regulation Number 21 CER 89… | 2001 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 7 companies; a new generation was cleared every 1.8 years on median.
- 3 of the 31 ancestors have a recall of any class.
- 7 other devices also cite its predicate K061214.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
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…
Read the full statement (115 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120734 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120734: Microsoft Amalga Uis Image Processing Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120734
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026