510(k) · Cleared
Recalled · Class II · 2017AIRO Computed Tomography (CT) X-ray System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mobius Imaging · JAK System, X-Ray, Tomography, Computed
Cleared on Apr 19, 2016 as substantially equivalent to K131431 (Mobius Imaging, LLC, 2013) after a 90-day review. Its family tree reaches back 9 generations to 1995. 1 of the 28 devices in its family, counting itself, has a Class I recall. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Apr 19, 2016
- Review
- 90 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 9 generations to K944131 (1995). 26 ancestors in all, the oldest K780395 (1978). 1 later device descends from it, 1 citing it directly. 1 of the 28 devices in this family, counting this one, has a Class I recall.
- Root · 9 generations backK944131 Anatom 2000Analogic Corp. · 1995
- 5 generations between
- 3 generations backK071806 Eclos Computed Tomography X-Ray SystemHitachi Medical Systems America, Inc. · 2007 · Recalled
- 2 generations backK102677 Bodytom NL 4000Neurologica Corporation · 2011
- 1 generation backK131431 Airo CT SystemMobius Imaging, LLC · 2013 · Recalled
- This deviceK160126 AIRO Computed Tomography (CT) X-ray SystemMobius Imaging · 2016
- Descendant · cites it directly · 0 of its ownK180393 AIRO Computed Tomography (CT) X-ray SystemMobius Imaging, LLC · 2018 · Recalled
Show all 9 generations
- Root · 9 generations backK944131 Anatom 2000Analogic Corp. · 1995
- 8 generations backK964890 Anatom 2000Analogic Corp. · 1997
- 7 generations backK982631 Philips Tomoscan CSPhilips Medical Systems, Inc. · 1998
- 6 generations backK991278 Philips Tomoscan AV-NTPhilips Medical Systems North America, Inc. · 1999
- 5 generations backK014240 ProntoHitachi Medical Systems America, Inc. · 2002
- 4 generations backK040902 Hitachi PrestoHitachi Medical Systems America, Inc. · 2004 · Recalled
- 3 generations backK071806 Eclos Computed Tomography X-Ray SystemHitachi Medical Systems America, Inc. · 2007 · Recalled
- 2 generations backK102677 Bodytom NL 4000Neurologica Corporation · 2011
- 1 generation backK131431 Airo CT SystemMobius Imaging, LLC · 2013 · Recalled
- This deviceK160126 AIRO Computed Tomography (CT) X-ray SystemMobius Imaging · 2016
Class I recalls in this family
- K962738 Millennium MT and Millennium MG Nuclear Medicine…5 generations back · 1996
Most influential descendants
Showing 1 of 1 · See all- K180393AIRO Computed Tomography (CT) X-ray SystemMobius Imaging, LLC · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K944131 | Anatom 2000 | Analogic Corp. | 1995 | — |
| −8 | K964890 | Anatom 2000 | Analogic Corp. | 1997 | — |
| −7 | K982631 | Philips Tomoscan CS | Philips Medical Systems, Inc. | 1998 | — |
| −6 | K991278 | Philips Tomoscan AV-NT | Philips Medical Systems North America, Inc. | 1999 | — |
| −5 | K014240 | Pronto | Hitachi Medical Systems America, Inc. | 2002 | — |
| −4 | K040902 | Hitachi Presto | Hitachi Medical Systems America, Inc. | 2004 | 4 |
| −3 | K071806 | Eclos Computed Tomography X-Ray System | Hitachi Medical Systems America, Inc. | 2007 | 1 |
| −2 | K102677 | Bodytom NL 4000 | Neurologica Corporation | 2011 | — |
| −1 | K131431 | Airo CT System | Mobius Imaging, LLC | 2013 | 1 |
| 0 (this device) | K160126 | AIRO Computed Tomography (CT) X-ray System | Mobius Imaging | 2016 | — |
| +1 | K180393 | AIRO Computed Tomography (CT) X-ray System | Mobius Imaging, LLC | 2018 | 5 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1992 | 4 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 1 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K131431 | Airo CT SystemSummary page 4…te Device(s): The legally marketed device to which substantial equivalence is being claimed is as follows: • Airo Mobile CT System – Premarket Notification K131431 (cleared on September 26, 2013, product code 90 JAK) 4. Device Description: The Mobius Airo is a Mobile Intrao… | 2013 |
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 |
|---|---|---|---|
| K180393 | AIRO Computed Tomography (CT) X-ray System | 2018 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 26, 2017 | Class II | Z-0715-2018 | Under Investigation by firm | If the tilt-drive motor has an intermittent connection or broken encoder or sensor wire there is a risk of unintended or unpredictable device motion while the CT system is homing the axis at startup or preparing for a scan. |
| Jul 28, 2017 | Class II | Z-0509-2018 | Component design/selection | Risk of unintended motion while the AIRO system is in transport mode. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K962738Millennium MT and Millennium MG Nuclear Medicine SystemsGE Medical Systems · 1996 · 5 generations back · ◆ in the 1996 ancestors bar of FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 21 years and passes through 7 companies; a new generation was cleared every 2.5 years on median.
- 7 of the 26 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K180393 (Mobius Imaging, LLC, 2018) has gone furthest, with 0 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. 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 AIRO® is intended to be used for X-ray computed tomography applications for anatomy that can be imaged in the 107cm aperture excluding pediatric patients and patients weighing over 400 lbs (182 kg).
Contraindications:
Airo is contraindicated as the principal means of guidance during invasive procedures when real-time imaging is needed (e.g., CT Fluoroscopy procedures). In addition, the physician must verify navigation accuracy using an adequate verification method when used with Navigation Systems during surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160126 · printed Nov 5, 2026
Cite this page
510(k) Report. “K160126: AIRO Computed Tomography (CT) X-ray System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K160126
Report an extraction error
Are you the manufacturer?
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