510(k) · Cleared
ClearedWorkstationone Breast Imaging Workstation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Three Palm Software, LLC · LLZ System, Image Processing, Radiological
Cleared on Dec 11, 2007 as substantially equivalent to K033400 (Ge Medical Systems W-400, 2003) and 2 other predicates after a 20-day review. Its family tree reaches back 5 generations to 1991. 27 later devices descend from it.
- Decided
- Dec 11, 2007
- Review
- 20 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K904519 (1991). 17 ancestors in all. 27 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK904519 Agfa Diagnostic Center (Adc)Enhanced Imaging Technologies, Inc. · 1991
- 4 generations backK974597 Adc Compact (Agfa Diagnostic Center)Bayer Corp., Agfa Div. · 1998 · Recalled
- 3 generations backK013138 Adc Compact PlusAgfa-Gevaert AG · 2001
- 2 generations backK022881 Cedara I-SoftviewCedara Software Corp. · 2002 · Recalled
- 1 generation backK040468 Cedara I-Softview and Cedara I-ReadmammoCedara Software Corp. · 2004 · Recalled
- This deviceK073272 Workstationone Breast Imaging WorkstationThree Palm Software, LLC · 2007
- Descendant · cites it directly · 25 of its ownK082483 QuantraHologic, Inc. · 2008
- Descendant · 2 generations on · 24 of its ownK102556 Volpara, Version 1.3Matakina Technology Limited · 2010
- Descendant · 2 generations on · 11 of its ownK132742 M-VU Breast DensityVucomp, Inc. · 2013
- Descendant · 3 generations on · 8 of its ownK152028 Volpara Imaging SoftwareMatakina Technologies Limited · 2015
- Descendant · 3 generations on · 7 of its ownK170540 DM-DensityDensitas, Inc. · 2018
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K082483QuantraHologic, Inc. · 2008 · cites it directly25descendants
- K102556Volpara, Version 1.3Matakina Technology Limited · 2010 · 2 generations on24descendants
- K132742M-VU Breast DensityVucomp, Inc. · 2013 · 2 generations on11descendants
- K152028Volpara Imaging SoftwareMatakina Technologies Limited · 2015 · 3 generations on8descendants
- K170540DM-DensityDensitas, Inc. · 2018 · 3 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K904519 | Agfa Diagnostic Center (Adc) | Enhanced Imaging Technologies, Inc. | 1991 | — |
| −4 | K974597 | Adc Compact (Agfa Diagnostic Center) | Bayer Corp., Agfa Div. | 1998 | 1 |
| −3 | K013138 | Adc Compact Plus | Agfa-Gevaert AG | 2001 | — |
| −2 | K022881 | Cedara I-Softview | Cedara Software Corp. | 2002 | 3 |
| −1 | K040468 | Cedara I-Softview and Cedara I-Readmammo | Cedara Software Corp. | 2004 | 1 |
| 0 (this device) | K073272 | Workstationone Breast Imaging Workstation | Three Palm Software, LLC | 2007 | — |
| +1 | K082483 | Quantra | Hologic, Inc. | 2008 | — |
| +2 | K102556 | Volpara, Version 1.3 | Matakina Technology Limited | 2010 | — |
| +2 | K132742 | M-VU Breast Density | Vucomp, Inc. | 2013 | — |
| +3 | K152028 | Volpara Imaging Software | Matakina Technologies Limited | 2015 | — |
| +3 | K170540 | DM-Density | Densitas, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 5 | 0 |
| 2020 | 2 | 0 |
| 2021 | 4 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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? (3)
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 |
|---|---|---|---|
| * | K033400 | Seno AdvantageSummary page 1…Trade 4 Name ! :: : : Manufacturer 510(k)Number Seno Advantage General Electric Medical K033400 Systems Cedara Cedara Software Corp.… | 2003 |
| * | K040468 | Cedara I-Softview and Cedara I-ReadmammoSummary page 1…ric Medical K033400 Systems Cedara Cedara Software Corp. K040468 I-ReadMammo Secta Workstation Sectra Imtec AB K063093 5.4. Device Description The W… | 2004 |
| * | K063093 | Sectra Workstation, Version 11.1Summary page 1…Cedara Software Corp. K040468 I-ReadMammo Secta Workstation Sectra Imtec AB K063093 5.4. Device Description The WorkstationOneTM is a diagnostic breast imaging workstation which consists of a software system that… | 2006 |
What descends from it? (27)
See all 272 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 16 years and passes through 5 companies; a new generation was cleared every 3.6 years on median.
- 7 of the 17 ancestors have a recall of any class.
- Of its descendants, K082483 (Hologic, Inc., 2008) has gone furthest, with 25 descendants of its own.
- 8 other devices also cite its predicate K033400.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 WorkstationOneTM Breast Imaging Workstation is intended for use with a regionally approved digital mammography system. The workstation displays images from multiple modalities, which include X-ray mammography MG, breast US and breast MRI. The workstation allows selection, display, manipulation, quantification, markup, print composition and media exchange of breast images. Here, quantification refers to measurements (such as area and distance) within…
Read the full statement (171 words)
The WorkstationOneTM Breast Imaging Workstation is intended for use with a regionally approved digital mammography system. The workstation displays images from multiple modalities, which include X-ray mammography MG, breast US and breast MRI. The workstation allows selection, display, manipulation, quantification, markup, print composition and media exchange of breast images. Here, quantification refers to measurements (such as area and distance) within a region of interest that the radiologist manually draws on the images. Similarly, markup refers to graphics that are manually drawn by the radiologist to indicate a region of interest. Note that the region of interest is not automatically generated by the computer.
The WorkstationOneTM Breast Imaging Workstation is intended for softcopy reading and interpretation of digital mammography images by Radiologists.
The WorkstationOneTM Breast Imaging Workstation when used for interpretation of images acquired using a FFDM image acquisition system shall display the images only on FDA-cleared high-resolution monitors. The images used for primary diagnostic reading must be in a lossless format, unless lossy formats are approved for use in digital mammography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073272 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073272: Workstationone Breast Imaging Workstation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073272
Report an extraction error
Are you the manufacturer?
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