510(k) · Cleared
ClearedDynapbv Body Software
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 Jul 30, 2012 as substantially equivalent to K011447 (Siemens Medical Solutions USA, Inc., 2001) and 1 other predicate after a 91-day review. Its family tree reaches back 5 generations to 1995.
- Decided
- Jul 30, 2012
- Review
- 91 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K954355 (1995). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK954355 Advantage Windows 3D with Navigator OptionGeneral Electric Co. · 1995
- 4 generations backK974715 Advantage 3D XRGE Medical Systems · 1998
- 3 generations backK984634 3D-AngioSiemens Medical Corp. · 1999
- 2 generations backK011447 IN Space 3DSiemens Medical Solutions USA, Inc. · 2001
- 1 generation backK111052 Syngo Neuro PBV-IRSiemens Medical Solutions USA, Inc. · 2011
- This deviceK121292 Dynapbv Body SoftwareSiemens Medical Solutions USA, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K954355 | Advantage Windows 3D with Navigator Option | General Electric Co. | 1995 | — |
| −4 | K974715 | Advantage 3D XR | GE Medical Systems | 1998 | — |
| −3 | K984634 | 3D-Angio | Siemens Medical Corp. | 1999 | — |
| −2 | K011447 | IN Space 3D | Siemens Medical Solutions USA, Inc. | 2001 | — |
| −1 | K111052 | Syngo Neuro PBV-IR | Siemens Medical Solutions USA, Inc. | 2011 | — |
| 0 (this device) | K121292 | Dynapbv Body Software | Siemens Medical Solutions USA, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 2000 | 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? (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 |
|---|---|---|---|
| * | K011447 | IN Space 3DSummary page 1…roduct Code: LLZ 4. Legally Marketed Predicate Device Trade Name: InSpace 3D Software Option 510O(k) #: K011447 Clearance Date: August 3, 2001 SIEM ENS syngo OvnaPBV Body 510(… | 2001 |
| * | K111052 | Syngo Neuro PBV-IRSummary page 2…Class 11 Product Code: JAA Legally Marketed Predicate Device Trade Name: syngo Neuro PBV 510(k) #: K1 11052 Clearance Date: May 20, 2011 Classification Name: System, Image Processing Radiological Classific… | 2011 |
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 17 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 8 ancestors has a recall of any class.
- 4 other devices also cite its predicate K011447.
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?
syngo DynaPBV Body is an extended software application to the InSpace 3D software option which allows the reconstruction of two-dimensional images acquired with a standard angiographic C-arm device into a three-dimensional image format.
syngo DynaPBV Body is intended for imaging primarily soft tissue for diagnosis, surgical planning, interventional procedures and treatment follow-up. It is design for the visualization of contrast enhanced blood distribution in the body using color coded relative values for diagnosis.,
This software is designed to visually assist physicians in the diagnosis and treatment of vessel malformations (i.e. Aneurysms, AVMV's and Stenoses)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121292 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121292: Dynapbv Body Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121292
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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