510(k) · Cleared
ClearedRealtime 3D Diagnostic 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 Nov 10, 1997 after an 89-day review. The FDA summary names its predicate without a number. 1 of the 387 devices in its family, counting itself, has a Class I recall. 386 later devices descend from it.
- Decided
- Nov 10, 1997
- Review
- 89 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 0
386 later devices descend from it, 5 citing it directly. 1 of the 387 devices in this family, counting this one, has a Class I recall.
- This deviceK973010 Realtime 3D Diagnostic WorkstationSiemens Medical Solutions USA, Inc. · 1997
- Descendant · cites it directly · 227 of its ownK030982 Syngo Colonography Software PackageSiemens Medical Solutions USA, Inc. · 2003
- Descendant · 2 generations on · 210 of its ownK033102 Medic Colon Model, Release 1Medicsight · 2003
- Descendant · 3 generations on · 209 of its ownK042674 Colon Car 1.2Medicsight · 2004
- Descendant · cites it directly · 177 of its ownK023003 Imagechecker-CT WorkstationR2 Technology, Inc. · 2002
- Descendant · 2 generations on · 170 of its ownK032748 VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc. · 2003 · Recalled
Showing 5 of 386 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…9 generations on · 2025
Most influential descendants
Showing 5 of 386 · See all- K030982Syngo Colonography Software PackageSiemens Medical Solutions USA, Inc. · 2003 · cites it directly227descendants
- K033102Medic Colon Model, Release 1Medicsight · 2003 · 2 generations on210descendants
- K042674Colon Car 1.2Medicsight · 2004 · 3 generations on209descendants
- K023003Imagechecker-CT WorkstationR2 Technology, Inc. · 2002 · cites it directly177descendants
- K032748VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc. · 2003 · 2 generations on170descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K973010 | Realtime 3D Diagnostic Workstation | Siemens Medical Solutions USA, Inc. | 1997 | — |
| +1 | K030982 | Syngo Colonography Software Package | Siemens Medical Solutions USA, Inc. | 2003 | — |
| +2 | K033102 | Medic Colon Model, Release 1 | Medicsight | 2003 | — |
| +3 | K042674 | Colon Car 1.2 | Medicsight | 2004 | — |
| +1 | K023003 | Imagechecker-CT Workstation | R2 Technology, Inc. | 2002 | — |
| +2 | K032748 | VITREA2, Version 3.4 Medical Image Processing Software | Vital Images, Inc. | 2003 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2003 | 5 | 0 |
| 2004 | 10 | 0 |
| 2005 | 3 | 0 |
| 2006 | 7 | 0 |
| 2007 | 7 | 0 |
| 2008 | 5 | 0 |
| 2009 | 8 | 0 |
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 16 | 0 |
| 2013 | 9 | 0 |
| 2014 | 10 | 0 |
| 2015 | 10 | 0 |
| 2016 | 9 | 0 |
| 2017 | 19 | 0 |
| 2018 | 29 | 0 |
| 2019 | 24 | 0 |
| 2020 | 26 | 0 |
| 2021 | 23 | 0 |
| 2022 | 29 | 0 |
| 2023 | 29 | 0 |
| 2024 | 34 | 0 |
| 2025 | 36 | 1 |
| 2026 | 29 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | — | Vitrea™ 3D Medical Visualization System Named without a submission number | |
| * | — | MagicView Diagnostic Workstation Named without a submission number |
What descends from it? (386)
See all 3865 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH · 2025 · 9 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K030982 (Siemens Medical Solutions USA, Inc., 2003) has gone furthest, with 227 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.
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?
From user specified sets of CT or MR images, Realtime 3D can be uscd for 3D presentation of the complete anatomic structure (i.c. head, chest, abdomcn) covered by the original CT or MR images for diagnosis and use in treatment planning; diagnosing as well as treatment planning [rom real time Multi-Planar-Reconstruction (MPR):the Realtime 3D too! can help the user to pusilion and visualize the 3-dimensional location of the MPR within the 3D volume by…
Read the full statement (157 words)
From user specified sets of CT or MR images, Realtime 3D can be uscd for
3D presentation of the complete anatomic structure (i.c. head, chest, abdomcn) covered by the original CT or MR images for diagnosis and use in treatment planning;
diagnosing as well as treatment planning [rom real time Multi-Planar-Reconstruction (MPR):the Realtime 3D too! can help the user to pusilion and visualize the 3-dimensional location of the MPR within the 3D volume by using interactive clip planes in real time;
CTA and MRA displaying cnhanced vessels;
measurement of anatomical saucturcs in the 3D volume. Important for quantitative measurcment of geometry and length of anatomy indices:
displaying the position of anatomical structures in relaionship to cach other;
navigating interactively through anatomical structures (e.g., vesscls, colon, spine, lung, etc.) or inside the 3D volume;
depth perception using the Sterco display option to visualize i.e. overlaying and underlying vessels:
far viewing the inner surface of organs (vessels, colon, etc.);
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/K973010 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973010: Realtime 3D Diagnostic Workstation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973010
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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