510(k) · Cleared
ClearedHelicat
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elscint, Inc. · JAK System, X-Ray, Tomography, Computed
Cleared on Mar 19, 1993 after a 70-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 267 later devices descend from it.
- Decided
- Mar 19, 1993
- Review
- 70 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 0
267 later devices descend from it, 2 citing it directly.
- This deviceK930090 HelicatElscint, Inc. · 1993
- Descendant · cites it directly · 265 of its ownK961464 Select/SPElscint, Inc. · 1996 · Recalled
- Descendant · 2 generations on · 264 of its ownK982060 Volumax CT Imaging SystemElscint, Inc. · 1998
- Descendant · 3 generations on · 263 of its ownK012009 MX8000 Idt CT SystemMarconi Medical Systems, Inc. · 2001 · Recalled
- Descendant · 4 generations on · 214 of its ownK033326 Philips Plus Computed Tomography SystemPhilips Medical Systems, Inc. · 2003 · Recalled
- Descendant · 4 generations on · 147 of its ownK042293 Brilliance CT, Private Practice CV Configuration, CT ScannerPhilips Medical Systems (Cleveland), Inc. · 2004 · Recalled
Showing 5 of 267 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 267 · See all- K961464Select/SPElscint, Inc. · 1996 · cites it directly265descendants
- K982060Volumax CT Imaging SystemElscint, Inc. · 1998 · 2 generations on264descendants
- K012009MX8000 Idt CT SystemMarconi Medical Systems, Inc. · 2001 · 3 generations on263descendants
- K033326Philips Plus Computed Tomography SystemPhilips Medical Systems, Inc. · 2003 · 4 generations on214descendants
- K042293Brilliance CT, Private Practice CV Configuration, CT ScannerPhilips Medical Systems (Cleveland), Inc. · 2004 · 4 generations on147descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K930090 | Helicat | Elscint, Inc. | 1993 | — |
| +1 | K961464 | Select/SP | Elscint, Inc. | 1996 | 3 |
| +2 | K982060 | Volumax CT Imaging System | Elscint, Inc. | 1998 | — |
| +3 | K012009 | MX8000 Idt CT System | Marconi Medical Systems, Inc. | 2001 | 61 |
| +4 | K033326 | Philips Plus Computed Tomography System | Philips Medical Systems, Inc. | 2003 | 131 |
| +4 | K042293 | Brilliance CT, Private Practice CV Configuration, CT Scanner | Philips Medical Systems (Cleveland), Inc. | 2004 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 7 | 0 |
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 7 | 0 |
| 2009 | 4 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 6 | 0 |
| 2013 | 6 | 0 |
| 2014 | 9 | 0 |
| 2015 | 3 | 0 |
| 2016 | 5 | 0 |
| 2017 | 12 | 0 |
| 2018 | 14 | 0 |
| 2019 | 9 | 0 |
| 2020 | 22 | 0 |
| 2021 | 19 | 0 |
| 2022 | 22 | 0 |
| 2023 | 20 | 0 |
| 2024 | 19 | 0 |
| 2025 | 35 | 0 |
| 2026 | 26 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (267)
See all 2672 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K961464 (Elscint, Inc., 1996) has gone furthest, with 265 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 | — |
https://510kreport.com/device/K930090 · printed Nov 6, 2026
Cite this page
510(k) Report. “K930090: Helicat.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K930090
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026