510(k) · Cleared
ClearedAzurion R3.1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems B.V. · OWB Interventional Fluoroscopic X-Ray System
Cleared on Oct 24, 2025 as substantially equivalent to K200917 (Philips Medical Systems Nederland B.V., 2020) after a 133-day review. Its family tree reaches back 17 generations to 1980. 4 of the 60 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Oct 24, 2025
- Review
- 133 days
- Class
- Class II
- Product code
- OWB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 17 generations to K801623 (1980). 58 ancestors in all. 1 later device descends from it, 1 citing it directly. 4 of the 60 devices in this family, counting this one, have a Class I recall.
- Root · 17 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 13 generations between
- 3 generations backK172822 Azurion series R1.2Philips Medical Systems Nederland B.V. · 2017 · Recalled (Class I)
- 2 generations backK181830 Azurion R2.0Philips Medical Systems Nederland B.V. · 2018 · Recalled
- 1 generation backK200917 Azurion R2.1Philips Medical Systems Nederland B.V. · 2020 · Recalled (Class I)
- This deviceK251827 Azurion R3.1Philips Medical Systems B.V. · 2025
- Descendant · cites it directly · 0 of its ownK254186 Azurion R3.1Philips Medical Systems B.V. · 2026
Show all 17 generations
- Root · 17 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 16 generations backK962952 Olympus Ultrasonic Surgical System (Usu)Olympus Optical, Co. · 1996
- 15 generations backK972114 Olympus Sonosurg SystemThe Olympus Optical Co. · 1998
- 14 generations backK981993 Olympus Integrated Endosurgery System EndoalphaThe Olympus Optical Co. · 1998
- 13 generations backK994231 Siemens Integrated Operating System (Sios)Siemens Medical Corp. · 2000
- 12 generations backK052202 Axiom Artis - Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 11 generations backK073290 Artis Zee and ZeegoSiemens Medical Solutions USA, Inc. · 2008 · Recalled
- 10 generations backK090745 Artis Zee / Zeegos with SW VC14Siemens Medical Solutions USA, Inc. · 2009 · Recalled
- 9 generations backK102005 Allura Xper or Table SeriesPhilips Medical Systems North America, Inc. · 2010 · Recalled
- 8 generations backK130638 Alluraclarity Xper FD Series X-Ray SystemPhilips Medical Systems Nederland B.V. · 2013 · Recalled
- 7 generations backK133292 Allura Xper FD; or TablePhilips Medical Systems Nederland B.V. · 2014 · Recalled
- 6 generations backK141979 Allura Xper FD Series / Allura Xper or Table SeriesPhilips Medical Systems Netherland BV · 2014 · Recalled
- 5 generations backK162148 Allura Xper R9Philips Medical Systems Nethrlands BV · 2016 · Recalled
- 4 generations backK163715 Allura Xper R9Philips Medical Systems Nederland B.V. · 2017 · Recalled (Class I)
- 3 generations backK172822 Azurion series R1.2Philips Medical Systems Nederland B.V. · 2017 · Recalled (Class I)
- 2 generations backK181830 Azurion R2.0Philips Medical Systems Nederland B.V. · 2018 · Recalled
- 1 generation backK200917 Azurion R2.1Philips Medical Systems Nederland B.V. · 2020 · Recalled (Class I)
- This deviceK251827 Azurion R3.1Philips Medical Systems B.V. · 2025
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K254186Azurion R3.1Philips Medical Systems B.V. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K801623 | Cavitron Ultrasonic Surg. Aspir. Cusa | Cavitron Corp. | 1980 | — |
| −16 | K962952 | Olympus Ultrasonic Surgical System (Usu) | Olympus Optical, Co. | 1996 | — |
| −15 | K972114 | Olympus Sonosurg System | The Olympus Optical Co. | 1998 | — |
| −14 | K981993 | Olympus Integrated Endosurgery System Endoalpha | The Olympus Optical Co. | 1998 | — |
| −13 | K994231 | Siemens Integrated Operating System (Sios) | Siemens Medical Corp. | 2000 | — |
| −12 | K052202 | Axiom Artis - Modular Angiographic System | Siemens Medical Solutions USA, Inc. | 2006 | 29 |
| −11 | K073290 | Artis Zee and Zeego | Siemens Medical Solutions USA, Inc. | 2008 | 39 |
| −10 | K090745 | Artis Zee / Zeegos with SW VC14 | Siemens Medical Solutions USA, Inc. | 2009 | 7 |
| −9 | K102005 | Allura Xper or Table Series | Philips Medical Systems North America, Inc. | 2010 | 39 |
| −8 | K130638 | Alluraclarity Xper FD Series X-Ray System | Philips Medical Systems Nederland B.V. | 2013 | 39 |
| −7 | K133292 | Allura Xper FD; or Table | Philips Medical Systems Nederland B.V. | 2014 | 45 |
| −6 | K141979 | Allura Xper FD Series / Allura Xper or Table Series | Philips Medical Systems Netherland BV | 2014 | 81 |
| −5 | K162148 | Allura Xper R9 | Philips Medical Systems Nethrlands BV | 2016 | 3 |
| −4 | K163715 | Allura Xper R9 | Philips Medical Systems Nederland B.V. | 2017 | Class I |
| −3 | K172822 | Azurion series R1.2 | Philips Medical Systems Nederland B.V. | 2017 | Class I |
| −2 | K181830 | Azurion R2.0 | Philips Medical Systems Nederland B.V. | 2018 | 42 |
| −1 | K200917 | Azurion R2.1 | Philips Medical Systems Nederland B.V. | 2020 | Class I |
| 0 (this device) | K251827 | Azurion R3.1 | Philips Medical Systems B.V. | 2025 | — |
| +1 | K254186 | Azurion R3.1 | Philips Medical Systems B.V. | 2026 | — |
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 |
|---|---|---|
| 2026 | 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.
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 |
|---|---|---|---|
| * | K200917 | Azurion R2.1Summary page 5…Device 510(k) No. Company Name Product Code Device Name K200917 Philips Medical Systems Primary Code: OWB Nederland B.V.… | 2020 |
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 |
|---|---|---|---|
| K254186 | Azurion R3.1 | 2026 | 0 |
Has anything in its family been recalled? (4 Class I)
No FDA recall names this device.
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.
- K200917Azurion R2.1Philips Medical Systems Nederland B.V. · 2020 · Direct predicate · ◆ on the line of descent in FIG. 18 Class I recalls
- K172822Azurion series R1.2Philips Medical Systems Nederland B.V. · 2017 · 2 generations back · ◆ on the line of descent in FIG. 19 Class I recalls
- K163715Allura Xper R9Philips Medical Systems Nederland B.V. · 2017 · 3 generations back · ◆ on the line of descent in FIG. 17 Class I recalls
- K033737Allura Xper FD20Philips Medical Systems North America, Inc. · 2003 · 8 generations back · ◆ in the 2003 ancestors bar of FIG. 113 Class I recalls
What does this lineage say?
- The line of descent spans 45 years and passes through 10 companies; a new generation was cleared every 1.5 years on median.
- 24 of the 58 ancestors have a recall of any class; 4 have a Class I recall.
- Of its descendants, K254186 (Philips Medical Systems B.V., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K200917.
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. 2025, 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 Azurion 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 Azurion series can be…
Read the full statement (103 words)
The Azurion 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 Azurion series can be used in a hybrid Operating Room.
• The Azurion 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/K251827 · printed Nov 4, 2026
Cite this page
510(k) Report. “K251827: Azurion R3.1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K251827
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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