510(k) · Cleared
ClearedEnhanced Boundary for PCCT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems, LLC · JAK System, X-Ray, Tomography, Computed
Cleared on Jun 24, 2026 as substantially equivalent to K213715 (Ge Medical Systems, LLC, 2021) after a 219-day review. Its family tree reaches back 10 generations to 2001.
- Decided
- Jun 24, 2026
- Review
- 219 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K013561 (2001). No later device cites it as a predicate yet.
- Root · 10 generations backK013561 Lightspeed 4.0 CT Scanner SystemGE Medical Systems · 2001 · Recalled
- 6 generations between
- 3 generations backK163213 Revolution CTGe Medical Systems, LLC · 2016 · Recalled
- 2 generations backK191777 Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with…Ge Medical Systems, LLC · 2019 · Recalled
- 1 generation backK213715 Revolution Apex, Revolution Apex Elite, Revolution Apex Plus…Ge Medical Systems, LLC · 2021 · Recalled
- This deviceK253560 Enhanced Boundary for PCCTGe Medical Systems, LLC · 2026
Show all 10 generations
- Root · 10 generations backK013561 Lightspeed 4.0 CT Scanner SystemGE Medical Systems · 2001 · Recalled
- 9 generations backK030420 Lightspeed 5.0 Computed Tomography SystemGE Medical Systems · 2003 · Recalled
- 8 generations backK040372 Lightspeed 7.0 CT Scanner SystemGe Medical Systems, LLC · 2004 · Recalled
- 7 generations backK061817 Lightspeed 7.1 CT Scanner SystemGe Medical Systems, LLC · 2006 · Recalled
- 6 generations backK081105 GE Lightspeed CT750 HD (Lightspeed 8.0)GE Healthcare · 2008 · Recalled
- 5 generations backK120833 Discovery CT750 HDGe Medical Systems, LLC · 2012 · Recalled
- 4 generations backK133705 Revolution CTGe Medical Systems, LLC · 2014 · Recalled
- 3 generations backK163213 Revolution CTGe Medical Systems, LLC · 2016 · Recalled
- 2 generations backK191777 Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with…Ge Medical Systems, LLC · 2019 · Recalled
- 1 generation backK213715 Revolution Apex, Revolution Apex Elite, Revolution Apex Plus…Ge Medical Systems, LLC · 2021 · Recalled
- This deviceK253560 Enhanced Boundary for PCCTGe Medical Systems, LLC · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K013561 | Lightspeed 4.0 CT Scanner System | GE Medical Systems | 2001 | 5 |
| −9 | K030420 | Lightspeed 5.0 Computed Tomography System | GE Medical Systems | 2003 | 4 |
| −8 | K040372 | Lightspeed 7.0 CT Scanner System | Ge Medical Systems, LLC | 2004 | 5 |
| −7 | K061817 | Lightspeed 7.1 CT Scanner System | Ge Medical Systems, LLC | 2006 | 1 |
| −6 | K081105 | GE Lightspeed CT750 HD (Lightspeed 8.0) | GE Healthcare | 2008 | 5 |
| −5 | K120833 | Discovery CT750 HD | Ge Medical Systems, LLC | 2012 | 1 |
| −4 | K133705 | Revolution CT | Ge Medical Systems, LLC | 2014 | 14 |
| −3 | K163213 | Revolution CT | Ge Medical Systems, LLC | 2016 | 16 |
| −2 | K191777 | Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex… | Ge Medical Systems, LLC | 2019 | 18 |
| −1 | K213715 | Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex… | Ge Medical Systems, LLC | 2021 | 11 |
| 0 (this device) | K253560 | Enhanced Boundary for PCCT | Ge Medical Systems, LLC | 2026 | — |
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 |
|---|---|---|---|
| * | K213715 | Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex…Summary page 5…ce Information Device Name: Revolution Apex Manufacturer: GE Medical Systems, LLC 510(k) Number: K213715 Regulation Number/ Product Code: 21 CFR 892.1750 Computed tomography x-ray system / JAK… | 2021 |
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 25 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- 10 of the 10 ancestors have a recall of any class.
- 3 other devices also cite its predicate K213715.
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. 2026, 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?
Enhanced Boundary for PCCT is a deep learning-based CT processing method used for improved soft tissue delineation in routine head exams with and without contrast. Enhanced Boundary for PCCT may be used for patients of all ages.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253560 · printed Nov 5, 2026
Cite this page
510(k) Report. “K253560: Enhanced Boundary for PCCT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K253560
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026