510(k) · Cleared
Recalled · Class II · 2014Airo CT System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mobius Imaging, LLC · JAK System, X-Ray, Tomography, Computed
Cleared on Sep 26, 2013 as substantially equivalent to K102677 (Neurologica Corporation, 2011) after a 132-day review. Its family tree reaches back 8 generations to 1995. 1 of the 28 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it. It has been recalled once.
- Decided
- Sep 26, 2013
- Review
- 132 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 8 generations to K944131 (1995). 25 ancestors in all, the oldest K780395 (1978). 2 later devices descend from it, 1 citing it directly. 1 of the 28 devices in this family, counting this one, has a Class I recall.
- Root · 8 generations backK944131 Anatom 2000Analogic Corp. · 1995
- 7 generations backK964890 Anatom 2000Analogic Corp. · 1997
- 6 generations backK982631 Philips Tomoscan CSPhilips Medical Systems, Inc. · 1998
- 5 generations backK991278 Philips Tomoscan AV-NTPhilips Medical Systems North America, Inc. · 1999
- 4 generations backK014240 ProntoHitachi Medical Systems America, Inc. · 2002
- 3 generations backK040902 Hitachi PrestoHitachi Medical Systems America, Inc. · 2004 · Recalled
- 2 generations backK071806 Eclos Computed Tomography X-Ray SystemHitachi Medical Systems America, Inc. · 2007 · Recalled
- 1 generation backK102677 Bodytom NL 4000Neurologica Corporation · 2011
- This deviceK131431 Airo CT SystemMobius Imaging, LLC · 2013
- Descendant · cites it directly · 1 of its ownK160126 AIRO Computed Tomography (CT) X-ray SystemMobius Imaging · 2016 · Recalled
- Descendant · 2 generations on · 0 of its ownK180393 AIRO Computed Tomography (CT) X-ray SystemMobius Imaging, LLC · 2018 · Recalled
Class I recalls in this family
- K962738 Millennium MT and Millennium MG Nuclear Medicine…4 generations back · 1996
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K944131 | Anatom 2000 | Analogic Corp. | 1995 | — |
| −7 | K964890 | Anatom 2000 | Analogic Corp. | 1997 | — |
| −6 | K982631 | Philips Tomoscan CS | Philips Medical Systems, Inc. | 1998 | — |
| −5 | K991278 | Philips Tomoscan AV-NT | Philips Medical Systems North America, Inc. | 1999 | — |
| −4 | K014240 | Pronto | Hitachi Medical Systems America, Inc. | 2002 | — |
| −3 | K040902 | Hitachi Presto | Hitachi Medical Systems America, Inc. | 2004 | 4 |
| −2 | K071806 | Eclos Computed Tomography X-Ray System | Hitachi Medical Systems America, Inc. | 2007 | 1 |
| −1 | K102677 | Bodytom NL 4000 | Neurologica Corporation | 2011 | — |
| 0 (this device) | K131431 | Airo CT System | Mobius Imaging, LLC | 2013 | — |
| +1 | K160126 | AIRO Computed Tomography (CT) X-ray System | Mobius Imaging | 2016 | 2 |
| +2 | 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 |
|---|---|---|
| 2016 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K102677 | Bodytom NL 4000Summary page 1…legally marketed device to which substantial equivalence is being claimed is as follows: *Neurologica NL4000 BodyTom' m CT System - Premarket Notification K102677 (cleared on March 24, 2011, product code 90OJAK) 4. Device Description: The Mobius Airo is a mobile high reso… | 2011 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160126 | AIRO Computed Tomography (CT) X-ray System | 2016 | 1 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 8, 2014 | Class II | Z-1016-2015 | Software design | There is a risk that during the transfer of an image and navigation data to the Brainlab Curve Image Guided Surgery Navigation System after a CT scan, an error may occur, causing either no navigation data or incorrect navigation data… |
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 · 4 generations back · ◆ in the 1996 ancestors bar of FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 18 years and passes through 6 companies; a new generation was cleared every 2.5 years on median.
- 6 of the 25 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K160126 (Mobius Imaging, 2016) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K102677.
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. 2013, 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' m is intended to be used for non-contrast 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).
Airo is contraindicated as the principal means of guidance during surgical procedures. The physician must verify navigation accuracy using known anatomical landmarks or an equivalent verification method when used in surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131431 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131431: Airo CT System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131431
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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