510(k) · Cleared
ClearedCSBP-001A Body Organ Perfusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Toshiba America Medical Systems, In.C · JAK System, X-Ray, Tomography, Computed
Cleared on Jun 11, 2008 as substantially equivalent to K052839 (GE Healthcare, 2006) and 2 other predicates after a 14-day review. Its family tree reaches back 7 generations to 1991.
- Decided
- Jun 11, 2008
- Review
- 14 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K913770 (1991). 38 ancestors in all, the oldest K880965 (1988). No later device cites it as a predicate yet.
- 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 deviceK081482 CSBP-001A Body Organ Perfusion SystemToshiba America Medical Systems, In.C · 2008
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) | K081482 | CSBP-001A Body Organ Perfusion System | Toshiba America Medical Systems, In.C | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 2 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 4 | 0 |
| 1999 | 1 | 0 |
| 2001 | 5 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 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 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? (3)
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…CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard Predicate Device(s): GE CT Perfusion 4 (k052839) Siemens Symgo Perfusion (k073373) Philips Brillian… | 2006 |
| * | K073373 | Syngo Volume Perfusion-CT BodySummary page 1…ic X-ray Equipment Standard Predicate Device(s): GE CT Perfusion 4 (k052839) Siemens Symgo Perfusion (k073373) Philips Brilliance CT (k060397) Reason For Submission New Device Descr… | 2007 |
| * | K060937 | Brilliance Volume Our reading of the summary gave K060397, FDA’s number for RF Lesion Cannula, RF Thermolesion Cannula, Thermolesion… (PAJUNK GmbH Medizintechnologie). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Philips Brilliance CT”. | 2006 |
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 7 companies; a new generation was cleared every 1.8 years on median.
- 11 of the 38 ancestors have a recall of any class.
- 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. 2008, 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?
This software package has been designed to evaluate the perfusion of organs and tumors.
The software allows for the calculation of blood flow, blood volume and permeabi'lity from sets pf images reconstructed from dynamic CT data acquired after the injection of a contrast bolus.
The package also allows for the independent calculation of arterial and portal venous component of hepatic perfusion. It supports the evaluation of regions of interest and the visual inspection of time density curves.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081482 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081482: CSBP-001A Body Organ Perfusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081482
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