510(k) · Cleared
ClearedCerebral Blood Flow Analysis System (CBP), Model Number CSCP-001A
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 Oct 5, 2001 as substantially equivalent to K010042 (General Electric Co., 2001) and 1 other predicate after a 9-day review. Its family tree reaches back 2 generations to 1988.
- Decided
- Oct 5, 2001
- Review
- 9 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K880965 (1988). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK880965 Somatom PlusSiemens Medical Solutions USA, Inc. · 1988
- 1 generation backK982536 Perfusion CT (Computed Tomography) Software PackageSiemens Corp. · 1998
- This deviceK013214 Cerebral Blood Flow Analysis System (CBP), Model Number CSCP-001AToshiba America Medical Systems, In.C · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K880965 | Somatom Plus | Siemens Medical Solutions USA, Inc. | 1988 | — |
| −1 | K982536 | Perfusion CT (Computed Tomography) Software Package | Siemens Corp. | 1998 | — |
| 0 (this device) | K013214 | Cerebral Blood Flow Analysis System (CBP), Model Number CSCP-001A | Toshiba America Medical Systems, In.C | 2001 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 2001 | 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 |
|---|---|---|---|
| * | K010042 | CT Perfusion 2Summary page 1…Tomography, X-Ray [Fed. Reg. No. 892.1750, Pro. Code: II (per 21 CFR 892.1750) 21 CFR Subchapter J, Federal Diagnostic X-ray Equipment General Electric Perfusion CT 2 [K010042] Siemens Perfusion CT [K982536] Modification of cleared device The CSCP-001A is an image analysis software package, that will… | 2001 |
| * | K982536 | Perfusion CT (Computed Tomography) Software PackageSummary page 1…892.1750, Pro. Code: II (per 21 CFR 892.1750) 21 CFR Subchapter J, Federal Diagnostic X-ray Equipment General Electric Perfusion CT 2 [K010042] Siemens Perfusion CT [K982536] Modification of cleared device The CSCP-001A is an image analysis software package, that will be applied to the Toshiba TSX-10… | 1998 |
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 13 years and passes through 3 companies; a new generation was cleared every 10.7 years on median.
- None of the 5 ancestors has a recall.
- 4 other devices also cite its predicate K010042.
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.
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 Cerebral Blood Perfusion Package is an application software that permits cerebral perfusion imaging based upon dynamic CT images that are acquired after the injection of contrast. The software allows for visualization of apparent blood flow in brain tissue and pictorially illustrates perfusion parameters (CBP- cerebral blood perfusion, CBV cerebral blood volume, mtt - mean transit time, and ERR - CBP residual difference SD map) from a set of dynamic…
Read the full statement (111 words)
The Cerebral Blood Perfusion Package is an application software that permits cerebral perfusion imaging based upon dynamic CT images that are acquired after the injection of contrast. The software allows for visualization of apparent blood flow in brain tissue and pictorially illustrates perfusion parameters (CBP- cerebral blood perfusion, CBV cerebral blood volume, mtt - mean transit time, and ERR - CBP residual difference SD map) from a set of dynamic images. This package when used by a trained physician will assist in the assessment of the type and extent of cerebral perfusion disturbances. Additionally, the software allows for measurement of various values such as mean value, standard deviation, area and distance.
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/K013214 · printed Nov 5, 2026
Cite this page
510(k) Report. “K013214: Cerebral Blood Flow Analysis System (CBP), Model Number CSCP-001A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013214
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026