510(k) · Cleared
Recalled · Class II · 2021Allura Xper R9
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems Nethrlands BV · OWB Interventional Fluoroscopic X-Ray System
Cleared on Nov 23, 2016 as substantially equivalent to K141979 (Philips Medical Systems Netherland BV, 2014) after a 114-day review. Its family tree reaches back 12 generations to 1980. 4 of the 62 devices in its family, counting itself, have a Class I recall. 8 later devices descend from it. It has been recalled 3 times.
- Decided
- Nov 23, 2016
- Review
- 114 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 12 generations to K801623 (1980). 53 ancestors in all. 8 later devices descend from it, 1 citing it directly. 4 of the 62 devices in this family, counting this one, have a Class I recall.
- Root · 12 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 8 generations between
- 3 generations backK130638 Alluraclarity Xper FD Series X-Ray SystemPhilips Medical Systems Nederland B.V. · 2013 · Recalled
- 2 generations backK133292 Allura Xper FD; or TablePhilips Medical Systems Nederland B.V. · 2014 · Recalled
- 1 generation backK141979 Allura Xper FD Series / Allura Xper or Table SeriesPhilips Medical Systems Netherland BV · 2014 · Recalled
- This deviceK162148 Allura Xper R9Philips Medical Systems Nethrlands BV · 2016
- Descendant · cites it directly · 7 of its ownK163715 Allura Xper R9Philips Medical Systems Nederland B.V. · 2017 · Recalled (Class I)
- Descendant · 2 generations on · 6 of its ownK172822 Azurion series R1.2Philips Medical Systems Nederland B.V. · 2017 · Recalled (Class I)
- Descendant · 3 generations on · 5 of its ownK181830 Azurion R2.0Philips Medical Systems Nederland B.V. · 2018 · Recalled
- Descendant · 3 generations on · 4 of its ownK200917 Azurion R2.1Philips Medical Systems Nederland B.V. · 2020 · Recalled (Class I)
- Descendant · 4 generations on · 1 of its ownK251827 Azurion R3.1Philips Medical Systems B.V. · 2025
Show all 12 generations
- Root · 12 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 11 generations backK962952 Olympus Ultrasonic Surgical System (Usu)Olympus Optical, Co. · 1996
- 10 generations backK972114 Olympus Sonosurg SystemThe Olympus Optical Co. · 1998
- 9 generations backK981993 Olympus Integrated Endosurgery System EndoalphaThe Olympus Optical Co. · 1998
- 8 generations backK994231 Siemens Integrated Operating System (Sios)Siemens Medical Corp. · 2000
- 7 generations backK052202 Axiom Artis - Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 6 generations backK073290 Artis Zee and ZeegoSiemens Medical Solutions USA, Inc. · 2008 · Recalled
- 5 generations backK090745 Artis Zee / Zeegos with SW VC14Siemens Medical Solutions USA, Inc. · 2009 · Recalled
- 4 generations backK102005 Allura Xper or Table SeriesPhilips Medical Systems North America, Inc. · 2010 · Recalled
- 3 generations backK130638 Alluraclarity Xper FD Series X-Ray SystemPhilips Medical Systems Nederland B.V. · 2013 · Recalled
- 2 generations backK133292 Allura Xper FD; or TablePhilips Medical Systems Nederland B.V. · 2014 · Recalled
- 1 generation backK141979 Allura Xper FD Series / Allura Xper or Table SeriesPhilips Medical Systems Netherland BV · 2014 · Recalled
- This deviceK162148 Allura Xper R9Philips Medical Systems Nethrlands BV · 2016
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 8 · See all- K163715Allura Xper R9Philips Medical Systems Nederland B.V. · 2017 · cites it directly7descendants
- K172822Azurion series R1.2Philips Medical Systems Nederland B.V. · 2017 · 2 generations on6descendants
- K181830Azurion R2.0Philips Medical Systems Nederland B.V. · 2018 · 3 generations on5descendants
- K200917Azurion R2.1Philips Medical Systems Nederland B.V. · 2020 · 3 generations on4descendants
- K251827Azurion R3.1Philips Medical Systems B.V. · 2025 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K801623 | Cavitron Ultrasonic Surg. Aspir. Cusa | Cavitron Corp. | 1980 | — |
| −11 | K962952 | Olympus Ultrasonic Surgical System (Usu) | Olympus Optical, Co. | 1996 | — |
| −10 | K972114 | Olympus Sonosurg System | The Olympus Optical Co. | 1998 | — |
| −9 | K981993 | Olympus Integrated Endosurgery System Endoalpha | The Olympus Optical Co. | 1998 | — |
| −8 | K994231 | Siemens Integrated Operating System (Sios) | Siemens Medical Corp. | 2000 | — |
| −7 | K052202 | Axiom Artis - Modular Angiographic System | Siemens Medical Solutions USA, Inc. | 2006 | 29 |
| −6 | K073290 | Artis Zee and Zeego | Siemens Medical Solutions USA, Inc. | 2008 | 39 |
| −5 | K090745 | Artis Zee / Zeegos with SW VC14 | Siemens Medical Solutions USA, Inc. | 2009 | 7 |
| −4 | K102005 | Allura Xper or Table Series | Philips Medical Systems North America, Inc. | 2010 | 39 |
| −3 | K130638 | Alluraclarity Xper FD Series X-Ray System | Philips Medical Systems Nederland B.V. | 2013 | 39 |
| −2 | K133292 | Allura Xper FD; or Table | Philips Medical Systems Nederland B.V. | 2014 | 45 |
| −1 | K141979 | Allura Xper FD Series / Allura Xper or Table Series | Philips Medical Systems Netherland BV | 2014 | 81 |
| 0 (this device) | K162148 | Allura Xper R9 | Philips Medical Systems Nethrlands BV | 2016 | — |
| +1 | K163715 | Allura Xper R9 | Philips Medical Systems Nederland B.V. | 2017 | Class I |
| +2 | K172822 | Azurion series R1.2 | Philips Medical Systems Nederland B.V. | 2017 | Class I |
| +3 | K181830 | Azurion R2.0 | Philips Medical Systems Nederland B.V. | 2018 | 42 |
| +3 | K200917 | Azurion R2.1 | Philips Medical Systems Nederland B.V. | 2020 | Class I |
| +4 | K251827 | Azurion R3.1 | Philips Medical Systems B.V. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 10 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2002 | 5 | 0 |
| 2003 | 2 | 1 |
| 2004 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 2 |
| 2018 | 1 | 0 |
| 2020 | 1 | 1 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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.
4 devices in this family have 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 OWB device
- #1 K251602 Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6…score 18.3 · 18 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 |
|---|---|---|---|
| * | K141979 | Allura Xper FD Series / Allura Xper or Table SeriesSummary page 4…series R8.2.1 Manufacturer: Philips Medical Systems Nederland B.V. 510(k) Clearance: K141979 (Aug 19, 2014) Classification Name: Image-intensified fluoroscopic x-ray system… | 2014 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K163715 | Allura Xper R9 Class I | 2017 | 7 |
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 13, 2021 | Class II | Z-2476-2021 | Device Design | Early life failure of the ADUs only occurs when the hospital mains provide 480V to the system. This current voltage may lead to saturation and overheating of the coils that protect the IGBTs (insulated-gate bipolar transistor) of the ADU.… |
| Dec 23, 2019 | Class II | Z-1145-2020 | Software design | Due to a software defect, when a digital subtraction angiography (DSA) is exported to the VesselNavigator application, the DSA is displayed without subtraction. |
| Aug 18, 2017 | Class II | Z-0255-2018 | Software design | When using the downscale option with the Allura R9 system or Azurion R1.1 system, the measurements performed using the QA Basic Measurement tool will not be correctly exported to the external DICOM destination. |
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.
- K033737Allura Xper FD20Philips Medical Systems North America, Inc. · 2003 · 4 generations back · ◆ in the 2003 ancestors bar of FIG. 113 Class I recalls
- K163715Allura Xper R9Philips Medical Systems Nederland B.V. · 2017 · Cites it directly · ◆ in the 2017 descendants bar of FIG. 17 Class I recalls
- K172822Azurion series R1.2Philips Medical Systems Nederland B.V. · 2017 · 2 generations on · ◆ in the 2017 descendants bar of FIG. 19 Class I recalls
- K200917Azurion R2.1Philips Medical Systems Nederland B.V. · 2020 · 3 generations on · ◆ in the 2020 descendants bar of FIG. 18 Class I recalls
What does this lineage say?
- The line of descent spans 36 years and passes through 9 companies; a new generation was cleared every 1.9 years on median.
- 19 of the 53 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K163715 (Philips Medical Systems Nederland B.V., 2017) has gone furthest, with 7 descendants of its own.
- 2 other devices also cite its predicate K141979.
How does its category compare?
All OWB devicesOWB Interventional Fluoroscopic X-Ray System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · OWB
22in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OWB
148in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWB
42so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OWB
14,008in 2025
MAUDE reports naming product code OWB, 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 | 3 | 52 | 0 | 1 |
| 2008 | 4 | 135 | 1 | 0 |
| 2009 | 9 | 99 | 0 | 0 |
| 2010 | 7 | 66 | 0 | 0 |
| 2011 | 6 | 79 | 0 | 1 |
| 2012 | 6 | 37 | 0 | 1 |
| 2013 | 11 | 119 | 10 | 27 |
| 2014 | 15 | 158 | 9 | 103 |
| 2015 | 11 | 66 | 35 | 2,134 |
| 2016 | 16 | 103 | 13 | 4,074 |
| 2017 | 20 | 76 | 13 | 1,604 |
| 2018 | 23 | 54 | 6 | 1,449 |
| 2019 | 9 | 174 | 7 | 1,558 |
| 2020 | 16 | 53 | 8 | 1,581 |
| 2021 | 24 | 60 | 31 | 1,981 |
| 2022 | 21 | 90 | 24 | 2,932 |
| 2023 | 12 | 152 | 22 | 7,604 |
| 2024 | 13 | 126 | 11 | 7,942 |
| 2025 | 22 | 148 | 30 | 14,008 |
| 2026 | 15 | 221 | 42 | — |
What is it indicated for?
The Allura Xper R9 series (within the limits of the used Operating Room table) are intended for use to perform: • Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular and neuro procedures. • Cardiac imaging applications including diagnostics, interventional and minimally invasive surgery procedures. Additionally: • The Allura Xper R9…
Read the full statement (109 words)
The Allura Xper R9 series (within the limits of the used Operating Room table) are intended for use to perform:
• Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular and neuro procedures.
• Cardiac imaging applications including diagnostics, interventional and minimally invasive surgery procedures.
Additionally:
• The Allura Xper R9 series can be used in a hybrid Operating Room.
• The Allura Xper R9 series contain a number of features to support a flexible and patient centric procedural workflow.
Patient Population:
All human patients of all ages. Patient weight is limited to the specification of the patient table.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162148 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162148: Allura Xper R9.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162148
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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