510(k) · Cleared
Recalled · Class I · 2026Azurion R2.1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems Nederland B.V. · OWB Interventional Fluoroscopic X-Ray System
Cleared on May 1, 2020 as substantially equivalent to K172822 (Philips Medical Systems Nederland B.V., 2017) and 1 other predicate after a 25-day review. Its family tree reaches back 16 generations to 1980. 4 of the 62 devices in its family, counting itself, have a Class I recall. 4 later devices descend from it. It has been recalled 75 times, including 8 Class I recalls.
- Decided
- May 1, 2020
- Review
- 25 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 75 (8 Class I)
- Predicates
- 2
Its longest line of descent runs back 16 generations to K801623 (1980). 57 ancestors in all. 4 later devices descend from it, 2 citing it directly. 4 of the 62 devices in this family, counting this one, have a Class I recall.
- Root · 16 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 12 generations between
- 3 generations backK163715 Allura Xper R9Philips Medical Systems Nederland B.V. · 2017 · Recalled (Class I)
- 2 generations backK172822 Azurion series R1.2Philips Medical Systems Nederland B.V. · 2017 · Recalled (Class I)
- 1 generation backK181830 Azurion R2.0Philips Medical Systems Nederland B.V. · 2018 · Recalled
- This deviceK200917 Azurion R2.1Philips Medical Systems Nederland B.V. · 2020
- Descendant · cites it directly · 1 of its ownK251827 Azurion R3.1Philips Medical Systems B.V. · 2025
- Descendant · cites it directly · 1 of its ownK243376 uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK253726 uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK254186 Azurion R3.1Philips Medical Systems B.V. · 2026
Show all 16 generations
- Root · 16 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 15 generations backK962952 Olympus Ultrasonic Surgical System (Usu)Olympus Optical, Co. · 1996
- 14 generations backK972114 Olympus Sonosurg SystemThe Olympus Optical Co. · 1998
- 13 generations backK981993 Olympus Integrated Endosurgery System EndoalphaThe Olympus Optical Co. · 1998
- 12 generations backK994231 Siemens Integrated Operating System (Sios)Siemens Medical Corp. · 2000
- 11 generations backK052202 Axiom Artis - Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 10 generations backK073290 Artis Zee and ZeegoSiemens Medical Solutions USA, Inc. · 2008 · Recalled
- 9 generations backK090745 Artis Zee / Zeegos with SW VC14Siemens Medical Solutions USA, Inc. · 2009 · Recalled
- 8 generations backK102005 Allura Xper or Table SeriesPhilips Medical Systems North America, Inc. · 2010 · Recalled
- 7 generations backK130638 Alluraclarity Xper FD Series X-Ray SystemPhilips Medical Systems Nederland B.V. · 2013 · Recalled
- 6 generations backK133292 Allura Xper FD; or TablePhilips Medical Systems Nederland B.V. · 2014 · Recalled
- 5 generations backK141979 Allura Xper FD Series / Allura Xper or Table SeriesPhilips Medical Systems Netherland BV · 2014 · Recalled
- 4 generations backK162148 Allura Xper R9Philips Medical Systems Nethrlands BV · 2016 · Recalled
- 3 generations backK163715 Allura Xper R9Philips Medical Systems Nederland B.V. · 2017 · Recalled (Class I)
- 2 generations backK172822 Azurion series R1.2Philips Medical Systems Nederland B.V. · 2017 · Recalled (Class I)
- 1 generation backK181830 Azurion R2.0Philips Medical Systems Nederland B.V. · 2018 · Recalled
- This deviceK200917 Azurion R2.1Philips Medical Systems Nederland B.V. · 2020
Class I recalls in this family
Most influential descendants
Showing 4 of 4 · See all- K251827Azurion R3.1Philips Medical Systems B.V. · 2025 · cites it directly1descendant
- K243376uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd. · 2025 · cites it directly1descendant
- K253726uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd. · 2026 · 2 generations on0descendants
- K254186Azurion R3.1Philips Medical Systems B.V. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K801623 | Cavitron Ultrasonic Surg. Aspir. Cusa | Cavitron Corp. | 1980 | — |
| −15 | K962952 | Olympus Ultrasonic Surgical System (Usu) | Olympus Optical, Co. | 1996 | — |
| −14 | K972114 | Olympus Sonosurg System | The Olympus Optical Co. | 1998 | — |
| −13 | K981993 | Olympus Integrated Endosurgery System Endoalpha | The Olympus Optical Co. | 1998 | — |
| −12 | K994231 | Siemens Integrated Operating System (Sios) | Siemens Medical Corp. | 2000 | — |
| −11 | K052202 | Axiom Artis - Modular Angiographic System | Siemens Medical Solutions USA, Inc. | 2006 | 29 |
| −10 | K073290 | Artis Zee and Zeego | Siemens Medical Solutions USA, Inc. | 2008 | 39 |
| −9 | K090745 | Artis Zee / Zeegos with SW VC14 | Siemens Medical Solutions USA, Inc. | 2009 | 7 |
| −8 | K102005 | Allura Xper or Table Series | Philips Medical Systems North America, Inc. | 2010 | 39 |
| −7 | K130638 | Alluraclarity Xper FD Series X-Ray System | Philips Medical Systems Nederland B.V. | 2013 | 39 |
| −6 | K133292 | Allura Xper FD; or Table | Philips Medical Systems Nederland B.V. | 2014 | 45 |
| −5 | K141979 | Allura Xper FD Series / Allura Xper or Table Series | Philips Medical Systems Netherland BV | 2014 | 81 |
| −4 | K162148 | Allura Xper R9 | Philips Medical Systems Nethrlands BV | 2016 | 3 |
| −3 | 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 |
| −1 | K181830 | Azurion R2.0 | Philips Medical Systems Nederland B.V. | 2018 | 42 |
| 0 (this device) | K200917 | Azurion R2.1 | Philips Medical Systems Nederland B.V. | 2020 | — |
| +1 | K251827 | Azurion R3.1 | Philips Medical Systems B.V. | 2025 | — |
| +1 | K243376 | uAngio AVIVA CX | Shanghai United Imaging Healthcare Co., Ltd. | 2025 | — |
| +2 | K253726 | uAngio AVIVA CX | Shanghai United Imaging Healthcare Co., Ltd. | 2026 | — |
| +2 | 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 |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K172822 | Azurion series R1.2Summary page 4…Azurion R1.2 Manufacturer: Philips Medical Systems Nederland B.V. 510(k) Clearance: K172822 (November 22, 2017) Classification Name: Image-intensified fluoroscopic x-ray system… | 2017 |
| * | K181830 | Azurion R2.0Summary page 4…Azurion R2.0 Device Manufacturer: Philips Medical Systems Nederland B.V. 510(k) Clearance: K181830 (August 02, 2018) Classification Name: Image-intensified fluoroscopic x-ray system… | 2018 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 6, 2026 | Not classified | Z-0295-2027 | Equipment maintenance | Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which may include reduced reliability over time such as loss of… |
| Oct 6, 2026 | Not classified | Z-0294-2027 | Equipment maintenance | Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which may include reduced reliability over time such as loss of… |
| Oct 6, 2026 | Not classified | Z-0297-2027 | Equipment maintenance | Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which may include reduced reliability over time such as loss of… |
| Oct 6, 2026 | Not classified | Z-0299-2027 | Equipment maintenance | Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which may include reduced reliability over time such as loss of… |
| Oct 6, 2026 | Not classified | Z-0293-2027 | Equipment maintenance | Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which may include reduced reliability over time such as loss of… |
| Oct 6, 2026 | Not classified | Z-0292-2027 | Equipment maintenance | Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which may include reduced reliability over time such as loss of… |
| Oct 6, 2026 | Not classified | Z-0298-2027 | Equipment maintenance | Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which may include reduced reliability over time such as loss of… |
| Oct 6, 2026 | Not classified | Z-0300-2027 | Equipment maintenance | Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which may include reduced reliability over time such as loss of… |
| Oct 6, 2026 | Not classified | Z-0296-2027 | Equipment maintenance | Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which may include reduced reliability over time such as loss of… |
| Jul 16, 2026 | Class II | Z-2932-2026 | Software design | Two software related issues affecting Philips Azurion R3.0 and R3.1 systems: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss of… |
| Jul 16, 2026 | Class II | Z-2931-2026 | Software design | Two software related issues affecting Azurion R2.2.10 Systems: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss of geometry movements… |
| Jun 17, 2026 | Class II | Z-2892-2026 | Under Investigation by firm | Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives. |
| Apr 28, 2026 | Class II | Z-2225-2026 | Device Design | Potential safety issue with Philips Azurion systems, where longitudinal and transverse table movements may be impacted due to mechanical wear of the Float Tabletop control on the control module. |
| Mar 31, 2026 | Class II | Z-2170-2026 | Device Design | Potential for the bolts and plastic parts of the Cable Hose Carriers that hold the cable hose to the monitor ceiling suspension may loosen and/or break over time due to the forces applied when the monitor is moved or rotated. |
| Jan 26, 2026 | Class II | Z-1346-2026 | Device Design | Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active. |
| Jan 26, 2026 | Class II | Z-1345-2026 | Device Design | Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active. |
| Jan 26, 2026 | Class II | Z-1347-2026 | Device Design | Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active. |
| Jan 26, 2026 | Class II | Z-1344-2026 | Device Design | Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active. |
| Jan 26, 2026 | Class II | Z-1350-2026 | Device Design | Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active. |
| Jan 26, 2026 | Class II | Z-1349-2026 | Device Design | Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active. |
| Jan 26, 2026 | Class II | Z-1348-2026 | Device Design | Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active. |
| Jan 26, 2026 | Class II | Z-1351-2026 | Device Design | Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active. |
| Dec 12, 2025 | Class II | Z-1113-2026 | Software design | Philips has identified two (2) software issues affecting device systems that may result in loss of imaging (X-ray) functionality and/or loss of motorized movement, and/or incorrect image content and/or loss of data. Issue 1 - System… |
| Dec 12, 2025 | Class II | Z-1091-2026 | Software design | Six (6) identified software issues which may result in the following: system keeps restarting, AMC triple drive, C-Partition of Suite PC running out of free space, system remains in continuous restart mode after the start-up, misalignment… |
| Dec 8, 2025 | Class II | Z-1079-2026 | Software design | Nine (9) identified software issues which may result in the following: loss of X-ray after Pedal Tap, loss of X-ray after Phase Fault, missing live X-ray on the FlexVision monitor, system continues to restart, AMD triple drive… |
| Oct 27, 2025 | Class II | Z-0597-2026 | Radiation Control for Health and Safety Act | Between July 2024 and June 2025, Philips Azurion R3.0 systems with a FlexArm stand were shipped without the Source-to-Skin Distance (SSD) Spacer. The SSD spacer is necessary to meet the FDA minimum source-skin distance requirement of 38… |
| Oct 2, 2025 | Class II | Z-0719-2026 | Equipment maintenance | The motorized longitudinal movement of the FlexArm stand may be inconsistent (not smooth) and eventually may become unavailable. This issue is due to grease leakage from the bearings and/or anti-corrosion oil applied on the bearings… |
| Aug 1, 2025 | Class II | Z-2502-2025 | Under Investigation by firm | Philips Azurion and Allura systems configured with a 1 Phase Uninterruptible Power Supply (UPS) have the potential of shutting down and/or not starting up, if power to the system is lost. |
| May 28, 2025 | Class II | Z-1969-2025 | Software design | A software issue was identified in the internal communication process between the system software and the X-ray generator firmware. Loss of imaging (X-ray) functionality caused by the software issue in either of the two situations… |
| Jan 13, 2025 | Class II | Z-1090-2025 | Device Design | Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the… |
| Jan 13, 2025 | Class I | Z-1153-2025 | Under Investigation by firm | Possibility of the patient falling from the table related to the mattress used on the patient table. |
| Jan 13, 2025 | Class II | Z-1087-2025 | Device Design | Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the… |
| Jan 13, 2025 | Class II | Z-1089-2025 | Device Design | Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the… |
| Jan 13, 2025 | Class I | Z-1154-2025 | Under Investigation by firm | Possibility of the patient falling from the table related to the mattress used on the patient table. |
| Jan 13, 2025 | Class II | Z-1093-2025 | Device Design | Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the… |
| Jan 13, 2025 | Class I | Z-1155-2025 | Under Investigation by firm | Possibility of the patient falling from the table related to the mattress used on the patient table. |
| Jan 13, 2025 | Class I | Z-1158-2025 | Under Investigation by firm | Possibility of the patient falling from the table related to the mattress used on the patient table. |
| Jan 13, 2025 | Class II | Z-1092-2025 | Device Design | Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the… |
| Jan 13, 2025 | Class I | Z-1160-2025 | Under Investigation by firm | Possibility of the patient falling from the table related to the mattress used on the patient table. |
| Jan 13, 2025 | Class I | Z-1159-2025 | Under Investigation by firm | Possibility of the patient falling from the table related to the mattress used on the patient table. |
| Jan 13, 2025 | Class I | Z-1157-2025 | Under Investigation by firm | Possibility of the patient falling from the table related to the mattress used on the patient table. |
| Jan 13, 2025 | Class I | Z-1156-2025 | Under Investigation by firm | Possibility of the patient falling from the table related to the mattress used on the patient table. |
| Jan 13, 2025 | Class II | Z-1094-2025 | Device Design | Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the… |
| Jan 13, 2025 | Class II | Z-1088-2025 | Device Design | Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the… |
| Jan 13, 2025 | Class II | Z-1091-2025 | Device Design | Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the… |
| Aug 22, 2024 | Class II | Z-3165-2024 | Device Design | Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Result in Parts Falling and/or Part of the Cable Hose Dropping, and result in injury. |
| Aug 6, 2024 | Class II | Z-2953-2024 | Under Investigation by firm | The motorized longitudinal movement of the FlexArm stand may be inconsistent (not smooth) and eventually may become unavailable. This issue is due to grease leakage from the bearings and/or anti-corrosion oil applied on the bearings… |
| Jul 15, 2024 | Class II | Z-2534-2024 | Device Design | Potential Loss of Imaging (X-ray) Functionality and/or Longer Time to Perform Cold Restart |
| Feb 6, 2024 | Class II | Z-1178-2024 | Under Investigation by firm | Generator may fail due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) in PoInt EVR (Power Invertor). If a short circuit occurs, it will cause the fuses to trip and the system will become non-functional due to… |
| Feb 6, 2024 | Class II | Z-1177-2024 | Under Investigation by firm | Generator may fail due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) in PoInt EVR (Power Invertor). If a short circuit occurs, it will cause the fuses to trip and the system will become non-functional due to… |
The 5 latest of 50 recalls; the web page lists all.
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.
- K172822Azurion series R1.2Philips Medical Systems Nederland B.V. · 2017 · Direct predicate · ◆ on the line of descent in FIG. 19 Class I recalls
- K163715Allura Xper R9Philips Medical Systems Nederland B.V. · 2017 · 2 generations back · ◆ on the line of descent in FIG. 17 Class I recalls
- K033737Allura Xper FD20Philips Medical Systems North America, Inc. · 2003 · 7 generations back · ◆ in the 2003 ancestors bar of FIG. 113 Class I recalls
What does this lineage say?
- The line of descent spans 40 years and passes through 9 companies; a new generation was cleared every 1.5 years on median.
- 23 of the 57 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K251827 (Philips Medical Systems B.V., 2025) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K172822.
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. 2020, this device’s year, is highlighted.
FDA decisions per year · OWB
22in 2025
2007high 24 (2021) · low 3 (2007)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · OWB
148in 2025
2007high 221 (2026) · low 37 (2012)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWB
42so far in 2026, the most since 2007
2007high 42 (2026) · low 0 (2007)2026
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OWB
14,008in 2025
2007high 14,008 (2025) · low 0 (2008)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 Operation 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…
Read the full statement (102 words)
The Azurion series (within the limits of the Operation 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 Operation 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/K200917 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200917: Azurion R2.1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200917
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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