510(k) · Cleared
ClearedMaxFOV 2
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 Mar 2, 2021 as substantially equivalent to K023332 (GE Medical Systems, 2002) after an 81-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- Mar 2, 2021
- Review
- 81 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K000300 (2000). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K023332 | Lightspeed Ultra Computed Tomography System with Wide-ViewSummary page 4…Predicate Device Information Device Name: LightSpeed Ultra with Wide View Option Manufacturer: GE Medical Systems, LLC 510(k) Number: K023332, Cleared on October 23, 2002 Regulation Number/ 21 CFR 892.1750 Computed tomography x-ray system / JAK Product Code: Ref… | 2002 |
| † | K130901 | Somatom Definition as Open | 2014 |
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 21 years and passes through 3 companies; a new generation was cleared every 18.4 years on median.
- None of the 2 ancestors has a recall.
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. 2021, 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 deep learning based Max Field-of-View (MaxFOV 2) is a CT image reconstruction method intended to produce images of the head and whole-body using Axial, Helical, and Cine acquisitions. MaxFOV 2 is designed to extend the nominal display field of view (DFoV) for cases where patient size and positioning requirements result in a portion of the patient’s body to be outside of the nominal DFoV. These extended FoV images are intended for use in radiation…
Read the full statement (124 words)
The deep learning based Max Field-of-View (MaxFOV 2) is a CT image reconstruction method intended to produce images of the head and whole-body using Axial, Helical, and Cine acquisitions.
MaxFOV 2 is designed to extend the nominal display field of view (DFoV) for cases where patient size and positioning requirements result in a portion of the patient’s body to be outside of the nominal DFoV.
These extended FoV images are intended for use in radiation therapy planning and are clinically useful for the simulation and planning of radiation therapy for the treatment of cancer for patients. They can also be used for visualization of patient anatomy for cases not involving therapy planning. MaxFOV 2 is intended for patients of all ages, especially bariatric patients.
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/K203617 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203617: MaxFOV 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203617
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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