510(k) · Cleared
ClearedSyngo Neuro PBV-IR
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 May 20, 2011 as substantially equivalent to K011447 (Siemens Medical Solutions USA, Inc., 2001) after a 35-day review. Its family tree reaches back 4 generations to 1995. 1 later device descends from it.
- Decided
- May 20, 2011
- Review
- 35 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K954355 (1995). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK954355 Advantage Windows 3D with Navigator OptionGeneral Electric Co. · 1995
- 3 generations backK974715 Advantage 3D XRGE Medical Systems · 1998
- 2 generations backK984634 3D-AngioSiemens Medical Corp. · 1999
- 1 generation backK011447 IN Space 3DSiemens Medical Solutions USA, Inc. · 2001
- This deviceK111052 Syngo Neuro PBV-IRSiemens Medical Solutions USA, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK121292 Dynapbv Body SoftwareSiemens Medical Solutions USA, Inc. · 2012
Most influential descendants
Showing 1 of 1 · See all- K121292Dynapbv Body SoftwareSiemens Medical Solutions USA, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K954355 | Advantage Windows 3D with Navigator Option | General Electric Co. | 1995 | — |
| −3 | K974715 | Advantage 3D XR | GE Medical Systems | 1998 | — |
| −2 | K984634 | 3D-Angio | Siemens Medical Corp. | 1999 | — |
| −1 | K011447 | IN Space 3D | Siemens Medical Solutions USA, Inc. | 2001 | — |
| 0 (this device) | K111052 | Syngo Neuro PBV-IR | Siemens Medical Solutions USA, Inc. | 2011 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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? (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 |
|---|---|---|---|
| * | K011447 | IN Space 3DSummary page 2…Page 15 of 887 4. Legally Marketed Device Trade Name: InSpace 3D Software Option 510(k) Clearance K01 1447 Clearance Date August 3, 2001 Classification Name: Accessory to Angiographic X-Ray System Cla… | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121292 | Dynapbv Body Software | 2012 | 0 |
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 4 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K121292 (Siemens Medical Solutions USA, Inc., 2012) has gone furthest, with 0 descendants of its own.
- 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. 2011, 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 Neuro-PBV IR is an extended software application to the InSpace 3D software option which allows the reconstruction of two-dimentional images acquired with a standard angiographic C-arm device into a three-dimentional image format. Syngo Neuro-PBV-IR 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…
Read the full statement (99 words)
Syngo Neuro-PBV IR is an extended software application to the InSpace 3D software option which allows the reconstruction of two-dimentional images acquired with a standard angiographic C-arm device into a three-dimentional image format.
Syngo Neuro-PBV-IR 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 arterial and venous vessels in the head 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, AVM's and Stenoses)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111052 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111052: Syngo Neuro PBV-IR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111052
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