510(k) · Cleared
ClearedAlphapoint Imaging Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radlogics, Inc. · LLZ System, Image Processing, Radiological
Cleared on Apr 13, 2012 as substantially equivalent to K060378 (Vital Images, Inc., 2006) after an 85-day review. Its family tree reaches back 9 generations to 1991.
- Decided
- Apr 13, 2012
- Review
- 85 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K913770 (1991). 39 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 5 generations between
- 3 generations backK043333 VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · Recalled
- 2 generations backK052632 VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc. · 2005 · Recalled
- 1 generation backK060378 VITREA2 Version 3.8.1Vital Images, Inc. · 2006
- This deviceK120161 Alphapoint Imaging SoftwareRadlogics, Inc. · 2012
Show all 9 generations
- Root · 9 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 8 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 7 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 6 generations backK023003 Imagechecker-CT WorkstationR2 Technology, Inc. · 2002
- 5 generations backK032748 VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc. · 2003 · Recalled
- 4 generations backK040305 VITREA2 Version 3.5Vital Images, Inc. · 2004
- 3 generations backK043333 VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · Recalled
- 2 generations backK052632 VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc. · 2005 · Recalled
- 1 generation backK060378 VITREA2 Version 3.8.1Vital Images, Inc. · 2006
- This deviceK120161 Alphapoint Imaging SoftwareRadlogics, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −8 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −7 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −6 | K023003 | Imagechecker-CT Workstation | R2 Technology, Inc. | 2002 | — |
| −5 | K032748 | VITREA2, Version 3.4 Medical Image Processing Software | Vital Images, Inc. | 2003 | 2 |
| −4 | K040305 | VITREA2 Version 3.5 | Vital Images, Inc. | 2004 | — |
| −3 | K043333 | VITREA2, Version 3.7 Medical Image Processing System | Vital Images, Inc. | 2004 | 1 |
| −2 | K052632 | VITREA2 Version 3.8 Medical Image Processing Software | Vital Images, Inc. | 2005 | 2 |
| −1 | K060378 | VITREA2 Version 3.8.1 | Vital Images, Inc. | 2006 | — |
| 0 (this device) | K120161 | Alphapoint Imaging Software | Radlogics, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 7 | 0 |
| 2002 | 4 | 0 |
| 2003 | 4 | 0 |
| 2004 | 3 | 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? (1)
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 |
|---|---|---|---|
| * | K060378 | VITREA2 Version 3.8.1Summary page 1…Legally Marketed Predicate Devices The modified software is substantially equivalent to the Vitrea 2 software manufactured by Vital Images, Inc. and cleared pursuant to K060378. B. Device Description: The AlphaPoint system provides a full application framework with integration to PACS using DIC… | 2006 |
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 5 companies; a new generation was cleared every 11 months on median.
- 6 of the 39 ancestors have a recall of any class.
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 AlphaPoint software is a device that allows review, analysis, and interchange of CT
chest images. It is intended for use with CT Chest images to assist medical professionals
in image analysis. It is not intended to be the primary interpretation. The software
provides segmentation and Hounsfield numerical analysis values which are indicative of
various substances (i.e., air, lung, soft tissue, fat, water, transudlate, exudate, blood,
muscle and bone). The user can review, verify and correct the results of the system and
generate a report of the findings..
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120161 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120161: Alphapoint Imaging Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120161
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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