510(k) · Cleared
Clearedsyngo.CT Neuro Perfusion
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · JAK System, X-Ray, Tomography, Computed
Cleared on Oct 11, 2020 as substantially equivalent to K163284 (Siemens Medical Solutions USA, Inc., 2017) after a 66-day review. Its family tree reaches back 7 generations to 1988.
- Decided
- Oct 11, 2020
- Review
- 66 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K880965 (1988). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK880965 Somatom PlusSiemens Medical Solutions USA, Inc. · 1988
- 6 generations backK982536 Perfusion CT (Computed Tomography) Software PackageSiemens Corp. · 1998
- 5 generations backK033832 Syngo Perfusion-CTSiemens AG Medical Solutions · 2003
- 4 generations backK050867 Syngo Body Perfusion-CTSiemens AG · 2005
- 3 generations backK073238 Syngo Volume Perfusion-CT NeuroSiemens AG Medical Solutions · 2008
- 2 generations backK123541 Syngo.CT Neuro PerfusionSiemens Medical Systems, Inc. · 2013
- 1 generation backK163284 syngo. CT Neuro PerfusionSiemens Medical Solutions USA, Inc. · 2017
- This deviceK202213 syngo.CT Neuro PerfusionSiemens Medical Solutions USA, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K880965 | Somatom Plus | Siemens Medical Solutions USA, Inc. | 1988 | — |
| −6 | K982536 | Perfusion CT (Computed Tomography) Software Package | Siemens Corp. | 1998 | — |
| −5 | K033832 | Syngo Perfusion-CT | Siemens AG Medical Solutions | 2003 | — |
| −4 | K050867 | Syngo Body Perfusion-CT | Siemens AG | 2005 | — |
| −3 | K073238 | Syngo Volume Perfusion-CT Neuro | Siemens AG Medical Solutions | 2008 | — |
| −2 | K123541 | Syngo.CT Neuro Perfusion | Siemens Medical Systems, Inc. | 2013 | — |
| −1 | K163284 | syngo. CT Neuro Perfusion | Siemens Medical Solutions USA, Inc. | 2017 | — |
| 0 (this device) | K202213 | syngo.CT Neuro Perfusion | Siemens Medical Solutions USA, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 2001 | 1 | 0 |
| 2006 | 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? (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 |
|---|---|---|---|
| * | K163284 | syngo. CT Neuro PerfusionSummary page 4…ice Class: Class II Product Code: JAK III. Predicate Device Predicate Device Trade Name: syngo.CT Neuro Perfusion 510(k) Number: K163284 Clearance Date: 03/01/2017 Classification Name: Computed Tomography X-ray System Classification Panel: Radiology CFR… | 2017 |
| † | K182130 | iSchemaView RAPID | 2018 |
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 32 years and passes through 5 companies; a new generation was cleared every 3.9 years on median.
- 1 of the 11 ancestors has a recall of any class.
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. 2020, 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 syngo.CT Neuro Perfusion software package is designed to evaluate areas of brain perfusion. The software processes images or volumes that were reconstructed from continuously acquired CT data after the injection of contrast media. It generates the following result volumes: • Cerebral blood flow (CBF) • Cerebral blood volume (CBV) • Local bolus timing (time to start (TTS), time to peak (TTP), time to drain (TTD)) • Mean transit time (MTT) • Transit…
Read the full statement (211 words)
The syngo.CT Neuro Perfusion software package is designed to evaluate areas of brain perfusion. The software processes images or volumes that were reconstructed from continuously acquired CT data after the injection of contrast media.
It generates the following result volumes:
• Cerebral blood flow (CBF)
• Cerebral blood volume (CBV)
• Local bolus timing (time to start (TTS), time to peak (TTP), time to drain (TTD))
• Mean transit time (MTT)
• Transit time to the center of the IRF (TMax)
• Flow extraction product (permeability)
• Temporal MIP
• Temporal Average
• Baseline Volume
• Modified dynamic input data
The software allows the calculation of mirrored regions of interest and the visual inspection of time attenuation curves. One clinical application is to visualize the apparent blood perfusion and to calculate Hypoperfused Area and Mismatch Ratio in the brain tissue affected by acute stroke.
Areas of decreased perfusion appear as areas of changed signal intensity:
• Lower signal intensity for CBF and CBV
• Higher signal intensity for TTP, TTD, MTT, and TMax
A second application is to visualize blood brain barrier disturbances by modeling extra-vascular leakage of blood into the interstitial space. This additional capability may improve the differential diagnosis of brain tumors and may be helpful in therapy monitoring.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202213 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202213: syngo.CT Neuro Perfusion.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202213
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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