510(k) · Cleared
ClearedCSNP-001A Neuro Package
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 Nov 1, 2007 after a 38-day review. The FDA summary names its predicate without a number.
- Decided
- Nov 1, 2007
- Review
- 38 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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
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- #2 Held for the reportin the report
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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 |
|---|---|---|---|
| * | — | CSCP-00IA Cerebral Bloop Perfusion Analysis Package Named without a submission number |
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.
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. 2007, 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 CSNP-001A is a post processing package that has the capability to perform brain perfusion studies to include whole brain studies, when used by a trained physician, by using data that is acquired on a time sequential basis. This package provides the physician with the following information that can then be measured and analyzed in the assessment of brain trauma or stroke: TDC (time density curve) CBF: Blood flow in the capillary vessels of the…
Read the full statement (119 words)
The CSNP-001A is a post processing package that has the capability to perform brain perfusion studies to include whole brain studies, when used by a trained physician, by using data that is acquired on a time sequential basis. This package provides the physician with the following information that can then be measured and analyzed in the assessment of brain trauma or stroke:
TDC (time density curve)
CBF: Blood flow in the capillary vessels of the cerebral tissues.
CBV: Blood volume in the capillary vessels of the cerebral tissues.
MTT: Mean transit time of blood in the capillary vessels f the cerebral vessels.
TTP: Time to peak of the TDCs.
DLY: Delay of each voxel curve from the arterial curves.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072693 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072693: CSNP-001A Neuro Package.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072693
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026