510(k) · Cleared
ClearedAura 10 PET/CT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xeos Medical · QXL Cabinet, Emission Computed Tomography System
Cleared on Aug 10, 2023 as substantially equivalent to K210880 (Philips Medical Systems Nederland B.V., 2021) after an 86-day review. Its family tree reaches back 11 generations to 1993.
- Decided
- Aug 10, 2023
- Review
- 86 days
- Class
- Class II
- Product code
- QXL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K930090 (1993). 24 ancestors in all. No later device cites it as a predicate yet.
- Root · 11 generations backK930090 HelicatElscint, Inc. · 1993
- 7 generations between
- 3 generations backK052640 Gemini RaptorPhilips Medical Systems (Cleveland), Inc. · 2005 · Recalled
- 2 generations backK123599 Ingenuity Digital Pet/CTPhilips Healthcare (Cleveland) · 2013 · Recalled
- 1 generation backK210880 Vereos PET/CTPhilips Medical Systems Nederland B.V. · 2021
- This deviceK231420 Aura 10 PET/CTXeos Medical · 2023
Show all 11 generations
- Root · 11 generations backK930090 HelicatElscint, Inc. · 1993
- 10 generations backK961464 Select/SPElscint, Inc. · 1996 · Recalled
- 9 generations backK982060 Volumax CT Imaging SystemElscint, Inc. · 1998
- 8 generations backK012009 MX8000 Idt CT SystemMarconi Medical Systems, Inc. · 2001 · Recalled
- 7 generations backK032036 Gemini 16Philips Medical Systems (Cleveland), Inc. · 2003 · Recalled
- 6 generations backK041955 Gemini Pet/CT Imaging SystemPhilips Medical Systems (Cleveland), Inc. · 2004 · Recalled
- 5 generations backK042935 Gemini GXLPhilips Medical Systems (Cleveland), Inc. · 2004 · Recalled
- 4 generations backK051170 Gemini GXLPhilips Medical Systems (Cleveland), Inc. · 2005 · Recalled
- 3 generations backK052640 Gemini RaptorPhilips Medical Systems (Cleveland), Inc. · 2005 · Recalled
- 2 generations backK123599 Ingenuity Digital Pet/CTPhilips Healthcare (Cleveland) · 2013 · Recalled
- 1 generation backK210880 Vereos PET/CTPhilips Medical Systems Nederland B.V. · 2021
- This deviceK231420 Aura 10 PET/CTXeos Medical · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K930090 | Helicat | Elscint, Inc. | 1993 | — |
| −10 | K961464 | Select/SP | Elscint, Inc. | 1996 | 3 |
| −9 | K982060 | Volumax CT Imaging System | Elscint, Inc. | 1998 | — |
| −8 | K012009 | MX8000 Idt CT System | Marconi Medical Systems, Inc. | 2001 | 61 |
| −7 | K032036 | Gemini 16 | Philips Medical Systems (Cleveland), Inc. | 2003 | 2 |
| −6 | K041955 | Gemini Pet/CT Imaging System | Philips Medical Systems (Cleveland), Inc. | 2004 | 2 |
| −5 | K042935 | Gemini GXL | Philips Medical Systems (Cleveland), Inc. | 2004 | 2 |
| −4 | K051170 | Gemini GXL | Philips Medical Systems (Cleveland), Inc. | 2005 | 12 |
| −3 | K052640 | Gemini Raptor | Philips Medical Systems (Cleveland), Inc. | 2005 | 36 |
| −2 | K123599 | Ingenuity Digital Pet/CT | Philips Healthcare (Cleveland) | 2013 | 5 |
| −1 | K210880 | Vereos PET/CT | Philips Medical Systems Nederland B.V. | 2021 | — |
| 0 (this device) | K231420 | Aura 10 PET/CT | Xeos Medical | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 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.
Planning a device in QXL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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.
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 30 years and passes through 6 companies; a new generation was cleared every 2.2 years on median.
- 14 of the 24 ancestors have a recall of any class.
- 1 other device also cites its predicate K210880.
How does its category compare?
All QXL devicesQXL Cabinet, Emission Computed Tomography System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QXL
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · QXL
Too few QXL 510(k)s in any year since 2007 to give a median.
Recalls per year · QXL
No recall names QXL since 2007.
Adverse event reports per year · QXL
No MAUDE report names QXL since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The AURA 10 PET/CT system is a cabinet diagnostic imaging device that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The AURA 10 PET/CT system images harvested specimens from various anatomical regions in order to provide rapid verification that the correct tissue has been excised during the surgical procedure. Images can be obtained as CT only, PET only, or a combination of both by surgeon’s discretion. The AURA…
Read the full statement (117 words)
The AURA 10 PET/CT system is a cabinet diagnostic imaging device that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The AURA 10 PET/CT system images harvested specimens from various anatomical regions in order to provide rapid verification that the correct tissue has been excised during the surgical procedure. Images can be obtained as CT only, PET only, or a combination of both by surgeon’s discretion.
The AURA 10 cabinet PET/CT system provides an image of extent and degree of intensity radiopharmaceutical uptake in the specimen by PET and the anatomical information by CT, which will help the surgeon with further patient management.
The AURA 10 PET/CT system is not validated for margin detection.
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/K231420 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231420: Aura 10 PET/CT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231420
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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