510(k) · Cleared
Recalled · Class II · 2025AIRO 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, LLC · JAK System, X-Ray, Tomography, Computed
Cleared on Mar 15, 2018 as substantially equivalent to K160126 (Mobius Imaging, 2016) after a 30-day review. Its family tree reaches back 10 generations to 1995. 1 of the 28 devices in its family, counting itself, has a Class I recall. It has been recalled 5 times.
- Decided
- Mar 15, 2018
- Review
- 30 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 10 generations to K944131 (1995). 27 ancestors in all, the oldest K780395 (1978). No later device cites it as a predicate yet. 1 of the 28 devices in this family, counting this one, has a Class I recall.
- Root · 10 generations backK944131 Anatom 2000Analogic Corp. · 1995
- 6 generations between
- 3 generations backK102677 Bodytom NL 4000Neurologica Corporation · 2011
- 2 generations backK131431 Airo CT SystemMobius Imaging, LLC · 2013 · Recalled
- 1 generation backK160126 AIRO Computed Tomography (CT) X-ray SystemMobius Imaging · 2016 · Recalled
- This deviceK180393 AIRO Computed Tomography (CT) X-ray SystemMobius Imaging, LLC · 2018
Show all 10 generations
- Root · 10 generations backK944131 Anatom 2000Analogic Corp. · 1995
- 9 generations backK964890 Anatom 2000Analogic Corp. · 1997
- 8 generations backK982631 Philips Tomoscan CSPhilips Medical Systems, Inc. · 1998
- 7 generations backK991278 Philips Tomoscan AV-NTPhilips Medical Systems North America, Inc. · 1999
- 6 generations backK014240 ProntoHitachi Medical Systems America, Inc. · 2002
- 5 generations backK040902 Hitachi PrestoHitachi Medical Systems America, Inc. · 2004 · Recalled
- 4 generations backK071806 Eclos Computed Tomography X-Ray SystemHitachi Medical Systems America, Inc. · 2007 · Recalled
- 3 generations backK102677 Bodytom NL 4000Neurologica Corporation · 2011
- 2 generations backK131431 Airo CT SystemMobius Imaging, LLC · 2013 · Recalled
- 1 generation backK160126 AIRO Computed Tomography (CT) X-ray SystemMobius Imaging · 2016 · Recalled
- This deviceK180393 AIRO Computed Tomography (CT) X-ray SystemMobius Imaging, LLC · 2018
Class I recalls in this family
- K962738 Millennium MT and Millennium MG Nuclear Medicine…6 generations back · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K944131 | Anatom 2000 | Analogic Corp. | 1995 | — |
| −9 | K964890 | Anatom 2000 | Analogic Corp. | 1997 | — |
| −8 | K982631 | Philips Tomoscan CS | Philips Medical Systems, Inc. | 1998 | — |
| −7 | K991278 | Philips Tomoscan AV-NT | Philips Medical Systems North America, Inc. | 1999 | — |
| −6 | K014240 | Pronto | Hitachi Medical Systems America, Inc. | 2002 | — |
| −5 | K040902 | Hitachi Presto | Hitachi Medical Systems America, Inc. | 2004 | 4 |
| −4 | K071806 | Eclos Computed Tomography X-Ray System | Hitachi Medical Systems America, Inc. | 2007 | 1 |
| −3 | K102677 | Bodytom NL 4000 | Neurologica Corporation | 2011 | — |
| −2 | K131431 | Airo CT System | Mobius Imaging, LLC | 2013 | 1 |
| −1 | K160126 | AIRO Computed Tomography (CT) X-ray System | Mobius Imaging | 2016 | 2 |
| 0 (this device) | K180393 | AIRO Computed Tomography (CT) X-ray System | Mobius Imaging, LLC | 2018 | — |
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 |
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 |
|---|---|---|---|
| * | K160126 | AIRO Computed Tomography (CT) X-ray 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 K160126 (cleared on April 19, 2016, product code 90 JAK) 4. Device Description: The Mobius Airo is a Mobile Intraopera… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 4, 2025 | Class II | Z-1040-2026 | Labeling Change Control | AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label. |
| Dec 4, 2025 | Class II | Z-1041-2026 | Labeling Change Control | AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label. |
| Dec 7, 2022 | Class II | Z-0957-2023 | Use error | Stryker received one report of an injury to an untrained user that occurred while the untrained user was moving an Airo TruCT unit in reverse. The firm will increase visibility of instructions for users to consider when transporting the… |
| Nov 18, 2022 | Class II | Z-0344-2023 | Other | Stryker received a report of a battery fire involving an Airo TruCT unit previously subjected to bypass charging. The firm is notifying customers with units whose battery monitoring systems were bypassed to charge the batteries; the… |
| Aug 1, 2018 | Class II | Z-2991-2018 | Radiation Control for Health and Safety Act | The Tube Current Modulation feature (Modulated Scans) is not working in AIRO systems with software version 2.0.0.0, and operators would not be able to detect this fault until after a scan is completed. |
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 · 6 generations back · ◆ in the 1996 ancestors bar of FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 23 years and passes through 7 companies; a new generation was cleared every 2.5 years on median.
- 8 of the 27 ancestors have a recall of any class; 1 has a Class I 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. 2018, 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 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/K180393 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180393: AIRO Computed Tomography (CT) X-ray System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180393
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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