510(k) · Cleared
ClearedPerfusion CT (Computed Tomography) Software Package
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Corp. · JAK System, X-Ray, Tomography, Computed
Cleared on Nov 24, 1998 as substantially equivalent to K875088 (Siemens Medical Solutions USA, Inc., 1988) and 2 other predicates after a 126-day review. Its family tree reaches back 1 generation to 1988. 1 of the 200 devices in its family, counting itself, has a Class I recall. 196 later devices descend from it.
- Decided
- Nov 24, 1998
- Review
- 126 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K880965 (1988). 3 ancestors in all. 196 later devices descend from it, 2 citing it directly. 1 of the 200 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK880965 Somatom PlusSiemens Medical Solutions USA, Inc. · 1988
- This deviceK982536 Perfusion CT (Computed Tomography) Software PackageSiemens Corp. · 1998
- Descendant · cites it directly · 194 of its ownK033832 Syngo Perfusion-CTSiemens AG Medical Solutions · 2003
- Descendant · 2 generations on · 192 of its ownK050867 Syngo Body Perfusion-CTSiemens AG · 2005
- Descendant · 3 generations on · 169 of its ownK062351 Syngo Dual EnergySiemens Medical Solutions USA, Inc. · 2006
- Descendant · 4 generations on · 168 of its ownK073003 Syngo Dual Energy with Extended FunctionallySiemens Medi Cal Solutions, Inc. · 2008
- Descendant · 5 generations on · 117 of its ownK083524 Syngo Dual Energy with Extended FunationallySiemens Medical Solutions USA, Inc. · 2009
Showing 5 of 196 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…10 generations on · 2025
Most influential descendants
Showing 5 of 196 · See all- K033832Syngo Perfusion-CTSiemens AG Medical Solutions · 2003 · cites it directly194descendants
- K050867Syngo Body Perfusion-CTSiemens AG · 2005 · 2 generations on192descendants
- K062351Syngo Dual EnergySiemens Medical Solutions USA, Inc. · 2006 · 3 generations on169descendants
- K073003Syngo Dual Energy with Extended FunctionallySiemens Medi Cal Solutions, Inc. · 2008 · 4 generations on168descendants
- K083524Syngo Dual Energy with Extended FunationallySiemens Medical Solutions USA, Inc. · 2009 · 5 generations on117descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K880965 | Somatom Plus | Siemens Medical Solutions USA, Inc. | 1988 | — |
| 0 (this device) | K982536 | Perfusion CT (Computed Tomography) Software Package | Siemens Corp. | 1998 | — |
| +1 | K033832 | Syngo Perfusion-CT | Siemens AG Medical Solutions | 2003 | — |
| +2 | K050867 | Syngo Body Perfusion-CT | Siemens AG | 2005 | — |
| +3 | K062351 | Syngo Dual Energy | Siemens Medical Solutions USA, Inc. | 2006 | — |
| +4 | K073003 | Syngo Dual Energy with Extended Functionally | Siemens Medi Cal Solutions, Inc. | 2008 | — |
| +5 | K083524 | Syngo Dual Energy with Extended Funationally | Siemens Medical Solutions USA, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 7 | 0 |
| 2013 | 4 | 0 |
| 2014 | 8 | 0 |
| 2015 | 10 | 0 |
| 2016 | 9 | 0 |
| 2017 | 9 | 0 |
| 2018 | 12 | 0 |
| 2019 | 12 | 0 |
| 2020 | 19 | 0 |
| 2021 | 8 | 0 |
| 2022 | 16 | 0 |
| 2023 | 16 | 0 |
| 2024 | 16 | 0 |
| 2025 | 19 | 1 |
| 2026 | 16 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K875088 | Xenon CTSummary page 1…OM Plus 4, SOMATOM AR.STAR, SOMATOM Classic), is substantially equivalent to the following devices: SIEMENS Device Name FDA Clearance Number FDA Clearance Date Xenon CT K875088 6/26/88 Dynamic CT option (Somatom AR) K910839 5/15/91 (Somatom Plus) K 880963 3/28/88 Perfusion CT images, as compared with Xen… | 1988 |
| * | K910839 | Ultimate 3000Summary page 1…s substantially equivalent to the following devices: SIEMENS Device Name FDA Clearance Number FDA Clearance Date Xenon CT K875088 6/26/88 Dynamic CT option (Somatom AR) K910839 5/15/91 (Somatom Plus) K 880963 3/28/88 Perfusion CT images, as compared with Xenon CT images and Dynamic CT images, are acquire… | 1991 |
| * | K880965 | Somatom Plus Our OCR of the scanned summary read K880963, FDA’s number for Hac Autology Centers Dispensing Kit for Fib.Con. (Buckman Co., Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Dynamic CT option (Somatom Plus)”. | 1988 |
What descends from it? (196)
See all 1962 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH · 2025 · 10 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- None of the 3 ancestors has a recall.
- Of its descendants, K033832 (Siemens AG Medical Solutions, 2003) has gone furthest, with 194 descendants of its own.
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?
Perfusion CT is an application software package that permits cerebral perfusion imaging based on dynamic CT images continuously acquired after the injection of contrast. The package allows visualization of apparent blood flow in brain tissue and pictorially illustrates perfusion related parameters (i.e. relative cercbral blood flow, rclative cerebral blood volume, time to peak). By generating images of cerebral blood flow (CBF), cerebral blood volume…
Read the full statement (117 words)
Perfusion CT is an application software package that permits cerebral perfusion imaging based on dynamic CT images continuously acquired after the injection of contrast. The package allows visualization of apparent blood flow in brain tissue and pictorially illustrates perfusion related parameters (i.e. relative cercbral blood flow, rclative cerebral blood volume, time to peak). By generating images of cerebral blood flow (CBF), cerebral blood volume (CBV), and local bolus timing (i.e. time to peak) from one set of dynamic CT images, Perfusion CT aids the physician in the assessment of the type and extent of cerebral perfusion disturbances. The software package also allows the calculation of mirrored regions of interest and the visual inspection of time density curves.
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/K982536 · printed Nov 5, 2026
Cite this page
510(k) Report. “K982536: Perfusion CT (Computed Tomography) Software Package.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K982536
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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