510(k) · Cleared
ClearedMAMMOVISTA B.smart
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 Nov 12, 2021 as substantially equivalent to K123420 (Siemens Medical Solutions USA, Inc., 2013) after an 86-day review. Its family tree reaches back 4 generations to 2003. 2 later devices descend from it.
- Decided
- Nov 12, 2021
- Review
- 86 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K033712 (2003). 7 ancestors in all, the oldest K010938 (2001). 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK033712 Modification to Sectra IDS5 Radiology Workstation - Version 10.1Sectra-Imtec AB · 2003
- 3 generations backK040376 Sectra IDS5 Radiology Workstation; Sectra MPR Package; Sectra 3D…Sectra-Imtec AB · 2004
- 2 generations backK042868 Mammoreport Softcopy WorkstationSiemens Medical Solutions USA, Inc. · 2005
- 1 generation backK123420 Syngo, Breast CareSiemens Medical Solutions USA, Inc. · 2013 · Recalled
- This deviceK212621 MAMMOVISTA B.smartSiemens Medical Solutions USA, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK223501 ViewFinder Software Version 1.1Elaitra, Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK223363 MAMMOVISTA B.smart (VB70)Siemens Medical Solutions USA, Inc. · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K033712 | Modification to Sectra IDS5 Radiology Workstation - Version 10.1 | Sectra-Imtec AB | 2003 | — |
| −3 | K040376 | Sectra IDS5 Radiology Workstation; Sectra MPR Package; Sectra 3D Package | Sectra-Imtec AB | 2004 | — |
| −2 | K042868 | Mammoreport Softcopy Workstation | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −1 | K123420 | Syngo, Breast Care | Siemens Medical Solutions USA, Inc. | 2013 | 1 |
| 0 (this device) | K212621 | MAMMOVISTA B.smart | Siemens Medical Solutions USA, Inc. | 2021 | — |
| +1 | K223501 | ViewFinder Software Version 1.1 | Elaitra, Ltd. | 2023 | — |
| +1 | 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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K123420 | Syngo, Breast CareSummary page 5…1 4. Legally Marketed Predicate Device: Trade Name: syngo.Breast Care 510(k) Number: K123420 (Cleared February 1, 2013) Classification Name: Picture Archiving and Communications System Classification Pane… | 2013 |
What descends from it? (2)
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 18 years and passes through 2 companies; a new generation was cleared every 8.1 years on median.
- 4 of the 7 ancestors have a recall of any class.
- Of its descendants, K223501 (Elaitra, Ltd., 2023) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
MAMMOVISTA B.smart is a dedicated softcopy review environment for both screening and diagnostic mammography as well as digital breast tomosynthesis. Its user interface and workflow have been optimized to support experienced mammography and tomosynthesis reviewers in both screening and diagnostic reading. Efficiency and reading quality are supported by various specialized features. MAMMOVISTA B.smart provides visualization and image enhancement tools to aid a qualified radiologist in the review of digital mammography and digital breast tomosynthesis datasets, as well as other modalities of breast images.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K212621 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212621: MAMMOVISTA B.smart.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212621
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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