510(k) · Cleared
ClearedCT Perfusion Option
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems, Inc. · JAK System, X-Ray, Tomography, Computed
Cleared on Nov 24, 1999 as substantially equivalent to K960265 (GE Medical Systems, 1996) after a 15-day review. Its family tree reaches back 2 generations to 1991.
- Decided
- Nov 24, 1999
- Review
- 15 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K913475 (1991). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K913475 | Magnetic Resonance Diagnostic Device | GE Medical Systems | 1991 | — |
| −1 | K960265 | Advantage Windows with Functool Option | GE Medical Systems | 1996 | 1 |
| 0 (this device) | K993791 | CT Perfusion Option | Ge Medical Systems, Inc. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K960265 | Advantage Windows with Functool OptionSummary page 1…ices: The CT Perfusion is substantially equivalent to the devices listed below: Model: Functool Manufacturer: General Electric Medical Systems, Milwaukee, WI 510(k) #: K960265 Model: CT 9800 Regional Cerebral Blood Flow Manufacturer: General Electric Medical Systems, Milwaukee, W1 510(k) #: 83K0739 Dev… | 1996 |
| Kept off the family tree | K830739 | FDA’s K830739 is Pro-Guard Our OCR of the scanned summary read K830739, FDA’s number for Pro-Guard (Surgicot, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “GEMS CT 9800 Regional Cerebral Blood Flow”. Kept off the family tree. | 1983 |
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 8 years and passes through 2 companies; a new generation was cleared every 4.7 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 12 other devices also cite its predicate K960265.
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?
CT Perfusion is an image analysis software package that allows the user to produce dynamic image data and to generate information with regard to changes in image intensity over time. It supports the analysis of CT Perfusion images obtained by cine imaging after the injection of contrast and to calculate the various perfusion related parameters (ie: regional cerebral blood flow, regional cerebral blood volume, time to peak). The results are displayed in user-friendly graphic format as parametric images. This software runs on the Advantage Workstation (AW) platform and will aid physicians in the assessment of the extent and type of brain perfusion disturbances.
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/K993791 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993791: CT Perfusion Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993791
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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