510(k) · Cleared
ClearedP-Artis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
P-Cure, Ltd. · JAK System, X-Ray, Tomography, Computed
Cleared on Aug 8, 2016 as substantially equivalent to K033357 (Philips Medical Systems (Cleveland), Inc., 2004) and 1 other predicate after a 158-day review. Its family tree reaches back 5 generations to 1993. 1 later device descends from it.
- Decided
- Aug 8, 2016
- Review
- 158 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K930090 (1993). 13 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK930090 HelicatElscint, Inc. · 1993
- 4 generations backK961464 Select/SPElscint, Inc. · 1996 · Recalled
- 3 generations backK982060 Volumax CT Imaging SystemElscint, Inc. · 1998
- 2 generations backK012009 MX8000 Idt CT SystemMarconi Medical Systems, Inc. · 2001 · Recalled
- 1 generation backK033357 Acqsim-Multislice-CT, Model 453567042271Philips Medical Systems (Cleveland), Inc. · 2004 · Recalled
- This deviceK160611 P-ArtisP-Cure, Ltd. · 2016
- Descendant · cites it directly · 0 of its ownK250970 MarieLeo Cancer Care · 2025
Most influential descendants
Showing 1 of 1 · See all- K250970MarieLeo Cancer Care · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K930090 | Helicat | Elscint, Inc. | 1993 | — |
| −4 | K961464 | Select/SP | Elscint, Inc. | 1996 | 3 |
| −3 | K982060 | Volumax CT Imaging System | Elscint, Inc. | 1998 | — |
| −2 | K012009 | MX8000 Idt CT System | Marconi Medical Systems, Inc. | 2001 | 61 |
| −1 | K033357 | Acqsim-Multislice-CT, Model 453567042271 | Philips Medical Systems (Cleveland), Inc. | 2004 | 50 |
| 0 (this device) | K160611 | P-Artis | P-Cure, Ltd. | 2016 | — |
| +1 | K250970 | Marie | Leo Cancer Care | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K033357 | Acqsim-Multislice-CT, Model 453567042271Summary page 4…on Number: 892.1750 Product Code: JAK Device Class: II Panel: Radiology Predicate Devices: • AcQSim-Multislice-CT CT scanner [Philips Medical Systems] cleared under K033357 (regulation: 892.1750, Computed Tomography X-ray System, Class II, Product Code: JAK) • Somatom Plus 4 with Sliding Gantry Op… | 2004 |
| * | K991600 | Somatom Plus 4 with Sliding Gantry OptionSummary page 4…33357 (regulation: 892.1750, Computed Tomography X-ray System, Class II, Product Code: JAK) • Somatom Plus 4 with Sliding Gantry Option [Siemens Corp.] cleared under K991600 (regulation: 892.1750, Computed Tomography X-ray System, Class II; Product Code: JAK) Intended Use / Indication for Use:… | 1999 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250970 | Marie | 2025 | 0 |
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 23 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- 5 of the 13 ancestors have a recall of any class.
- Of its descendants, K250970 (Leo Cancer Care, 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K033357.
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. 2016, 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 P-ARTIS CT scanner is a Computed Tomography X-Ray System intended to produce images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. The system may include signal analysis and display equipment, patient and equipment supports, components and accessories. The system is intended for scanning patients while seated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160611 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160611: P-Artis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160611
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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