510(k) · Cleared
ClearedCSBP-001A Body Perfusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Toshibamedical Systems Corporation · JAK System, X-Ray, Tomography, Computed
Cleared on Mar 5, 2009 as substantially equivalent to K052839 (GE Healthcare, 2006) and 1 other predicate after a 7-day review. Its family tree reaches back 7 generations to 1991. 10 later devices descend from it.
- Decided
- Mar 5, 2009
- Review
- 7 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K913770 (1991). 27 ancestors in all, the oldest K880965 (1988). 10 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 6 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 5 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 4 generations backK033400 Seno AdvantageGe Medical Systems W-400 · 2003 · Recalled
- 3 generations backK043216 Cadstream Version 4.0Confirma, Inc. · 2005
- 2 generations backK052305 Mri Soft Tissue Motion Correction Software VA10ASiemens Medical Solutions USA, Inc. · 2005
- 1 generation backK073373 Syngo Volume Perfusion-CT BodySiemens AG Medical Solutions · 2007
- This deviceK090504 CSBP-001A Body Perfusion SystemToshibamedical Systems Corporation · 2009
- Descendant · cites it directly · 8 of its ownK121213 VitreaadvancedVital Images, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 5 of its ownK142521 Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc. · 2014
- Descendant · 3 generations on · 4 of its ownK151988 Visible Patient SuiteVisible Patient, Sas · 2015
- Descendant · 4 generations on · 3 of its ownK212896 Visible Patient SuiteVisible Patient, Sas · 2021
- Descendant · 5 generations on · 1 of its ownK250237 InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd. · 2025
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K121213VitreaadvancedVital Images, Inc. · 2012 · cites it directly8descendants
- K142521Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc. · 2014 · 2 generations on5descendants
- K151988Visible Patient SuiteVisible Patient, Sas · 2015 · 3 generations on4descendants
- K212896Visible Patient SuiteVisible Patient, Sas · 2021 · 4 generations on3descendants
- K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd. · 2025 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −6 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −5 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −4 | K033400 | Seno Advantage | Ge Medical Systems W-400 | 2003 | 6 |
| −3 | K043216 | Cadstream Version 4.0 | Confirma, Inc. | 2005 | — |
| −2 | K052305 | Mri Soft Tissue Motion Correction Software VA10A | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −1 | K073373 | Syngo Volume Perfusion-CT Body | Siemens AG Medical Solutions | 2007 | — |
| 0 (this device) | K090504 | CSBP-001A Body Perfusion System | Toshibamedical Systems Corporation | 2009 | — |
| +1 | K121213 | Vitreaadvanced | Vital Images, Inc. | 2012 | 1 |
| +2 | K142521 | Synapse 3D Liver and Kidney Analysis | Fujifilm Meidcal Systems U.S.A.,Inc. | 2014 | — |
| +3 | K151988 | Visible Patient Suite | Visible Patient, Sas | 2015 | — |
| +4 | K212896 | Visible Patient Suite | Visible Patient, Sas | 2021 | — |
| +5 | K250237 | InferOperate Suite | Beijing Infervision Healthcare Medical Technology Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 2 | 0 |
| 1991 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 JAK? 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 JAK device
- #1 K230223 iCAC Devicescore 23.5 · 12 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 |
|---|---|---|---|
| * | K052839 | CT Perfusion 4Summary page 1…ulatory Class: II (per 21 CFR 892.1750) Performance Standard: None Predicate Device(s): General Electric CT Perfusion 4 (k052839 Siemens syngo Perfusion (k073 373) Reason For Submission New software device… | 2006 |
| * | K073373 | Syngo Volume Perfusion-CT BodySummary page 1…e Standard: None Predicate Device(s): General Electric CT Perfusion 4 (k052839 Siemens syngo Perfusion (k073 373) Reason For Submission New software device Description of this Device: The CSBP-001A is a noninvasive post-proces… | 2007 |
What descends from it? (10)
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 7 companies; a new generation was cleared every 1.8 years on median.
- 6 of the 27 ancestors have a recall of any class.
- Of its descendants, K121213 (Vital Images, Inc., 2012) has gone furthest, with 8 descendants of its own.
- 6 other devices also cite its predicate K052839.
How does its category compare?
All JAK devicesJAK System, X-Ray, Tomography, Computed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · JAK
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAK
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAK
17in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAK
219in 2025
MAUDE reports naming product code JAK, 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 | 14 | 27 | 11 | 76 |
| 2008 | 26 | 42 | 16 | 120 |
| 2009 | 15 | 31 | 29 | 105 |
| 2010 | 7 | 92 | 51 | 119 |
| 2011 | 16 | 155 | 34 | 205 |
| 2012 | 28 | 121 | 23 | 192 |
| 2013 | 17 | 132 | 11 | 414 |
| 2014 | 30 | 200 | 10 | 308 |
| 2015 | 30 | 140 | 28 | 454 |
| 2016 | 25 | 129 | 44 | 365 |
| 2017 | 29 | 96 | 33 | 338 |
| 2018 | 24 | 114 | 10 | 543 |
| 2019 | 28 | 94 | 5 | 233 |
| 2020 | 30 | 112 | 8 | 177 |
| 2021 | 20 | 145 | 15 | 261 |
| 2022 | 30 | 131 | 9 | 199 |
| 2023 | 27 | 139 | 9 | 310 |
| 2024 | 26 | 141 | 20 | 212 |
| 2025 | 27 | 141 | 17 | 219 |
| 2026 | 21 | 167 | 23 | — |
What is it indicated for?
The Body Perfusion System software package is a noninvasive post-processing package that has been designed to evaluate perfusion of organs and tumors. The software can calculate blood flow, blood volume and permeability from sets of images reconstructed from dynamic CT data acquired after the injection of contrast media. The software also allows the separate calculation of the arterial and portal venous component of hepatic perfusion. It supports…
Read the full statement (127 words)
The Body Perfusion System software package is a noninvasive post-processing package that has been designed to evaluate perfusion of organs and tumors. The software can calculate blood flow, blood volume and permeability from sets of images reconstructed from dynamic CT data acquired after the injection of contrast media. The software also allows the separate calculation of the arterial and portal venous component of hepatic perfusion. It supports evaluation of regions of interest and the visual inspection of time density curves.
When used by a qualified physician a potential application is to differentiate blood flow between normal and diseased tissue. Determination of the change of perfusion parameters during the course of treatment may be helpful in therapy monitoring.
It should be used by a trained and qualified physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090504 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090504: CSBP-001A Body Perfusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090504
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