510(k) · Cleared
ClearedMammoreport Softcopy Workstation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · LLZ System, Image Processing, Radiological
Cleared on Jan 6, 2005 as substantially equivalent to P030010 (Siemens Medical Solution, 2004) and 2 other predicates after an 80-day review. Its family tree reaches back 2 generations to 2003. 7 later devices descend from it.
- Decided
- Jan 6, 2005
- Review
- 80 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K033712 (2003). 5 ancestors in all, the oldest K010938 (2001). 7 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK033712 Modification to Sectra IDS5 Radiology Workstation - Version 10.1Sectra-Imtec AB · 2003
- 1 generation backK040376 Sectra IDS5 Radiology Workstation; Sectra MPR Package; Sectra 3D…Sectra-Imtec AB · 2004
- This deviceK042868 Mammoreport Softcopy WorkstationSiemens Medical Solutions USA, Inc. · 2005
- Descendant · cites it directly · 3 of its ownK123420 Syngo, Breast CareSiemens Medical Solutions USA, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 2 of its ownK212621 MAMMOVISTA B.smartSiemens Medical Solutions USA, Inc. · 2021
- Descendant · cites it directly · 2 of its ownK052461 Syngo Imaging Version V20ASiemens AG Medical Solutions · 2005 · Recalled
- Descendant · 3 generations on · 0 of its ownK223501 ViewFinder Software Version 1.1Elaitra, Ltd. · 2023
- Descendant · 3 generations on · 0 of its ownK223363 MAMMOVISTA B.smart (VB70)Siemens Medical Solutions USA, Inc. · 2023
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K123420Syngo, Breast CareSiemens Medical Solutions USA, Inc. · 2013 · cites it directly3descendants
- K212621MAMMOVISTA B.smartSiemens Medical Solutions USA, Inc. · 2021 · 2 generations on2descendants
- K052461Syngo Imaging Version V20ASiemens AG Medical Solutions · 2005 · cites it directly2descendants
- K223501ViewFinder Software Version 1.1Elaitra, Ltd. · 2023 · 3 generations on0descendants
- K223363MAMMOVISTA B.smart (VB70)Siemens Medical Solutions USA, Inc. · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K033712 | Modification to Sectra IDS5 Radiology Workstation - Version 10.1 | Sectra-Imtec AB | 2003 | — |
| −1 | K040376 | Sectra IDS5 Radiology Workstation; Sectra MPR Package; Sectra 3D Package | Sectra-Imtec AB | 2004 | — |
| 0 (this device) | K042868 | Mammoreport Softcopy Workstation | Siemens Medical Solutions USA, Inc. | 2005 | — |
| +1 | K123420 | Syngo, Breast Care | Siemens Medical Solutions USA, Inc. | 2013 | 1 |
| +2 | K212621 | MAMMOVISTA B.smart | Siemens Medical Solutions USA, Inc. | 2021 | — |
| +1 | K052461 | Syngo Imaging Version V20A | Siemens AG Medical Solutions | 2005 | 3 |
| +3 | K223501 | ViewFinder Software Version 1.1 | Elaitra, Ltd. | 2023 | — |
| +3 | K223363 | MAMMOVISTA B.smart (VB70) | Siemens Medical Solutions USA, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2013 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 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 |
|---|---|---|---|
| * | P030010 | Siemens Mammomat Novationdr Full Field Digital Mammography SystemSummary page 1…(610) 448-1787 Date Prepared: October 15, 2004 Predicate Device: MammoReportPlUs soft copy review station (originally a part of the overall system, P030010, Siemens MAMMOMAT Novation DR FFDM system cleared on 8/20/04). Device Description: The MammoReportPlus is essentially a softwar… | 2004 |
| * | K040970 | LeonardoSummary page 2…with the Windows based operating system using a Siemens syngo graphical user interface (GUI) as is contained in the cleared predicate Leonardo Multimodality Workstation (K040970). In addition, the proposed device contains the same ability to receive and display CAD markers from an approved device, as well… | 2004 |
| * | K040376 | Sectra IDS5 Radiology Workstation; Sectra MPR Package; Sectra 3D PackageSummary page 2…ay CAD markers from an approved device, as well as the ability to view multimodality and mammography images as the cleared predicate device, the Sectra IDS5 Workstation (K040376). In addition to the cleared CRT monitors previously described in the original Siemens Mammomat Novation PMA submission, P030010… | 2004 |
What descends from it? (7)
2 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 2 years and passes through 2 companies; a new generation was cleared every 8 months on median.
- 3 of the 5 ancestors have a recall of any class.
- Of its descendants, K123420 (Siemens Medical Solutions USA, Inc., 2013) has gone furthest, with 3 descendants of its own.
- 5 other devices also cite its predicate P030010.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 MammoReportPlus is a medical diagnostic workstation for viewing, manipulation, communication, reporting and storage of medical images and data on exchange media including mammography images. It interfaces to various image storage and printing devices using DICOM or similar interface standards. The MammoReportPlus used with FDA cleared monitors may be used by trained physicians for display, manipulation and interpretation of lossless compressed or…
Read the full statement (104 words)
The MammoReportPlus is a medical diagnostic workstation for viewing, manipulation, communication, reporting and storage of medical images and data on exchange media including mammography images. It interfaces to various image storage and printing devices using DICOM or similar interface standards.
The MammoReportPlus used with FDA cleared monitors may be used by trained physicians for display, manipulation and interpretation of lossless compressed or non-compressed mammography images and diagnostic mammography, as well as any other DICOM multi-modality image. CAD markers created by FDA approved devices may be displayed.
Trained professionals, including, but not limited to physicians, radiologists, nurses, medical technicians and assistants, typically use the MammoReportPlus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042868 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042868: Mammoreport Softcopy Workstation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042868
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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