510(k) · Cleared
CleareduAngio AVIVA CX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shanghai United Imaging Healthcare Co., Ltd. · OWB Interventional Fluoroscopic X-Ray System
Cleared on Apr 28, 2025 as substantially equivalent to K200917 (Philips Medical Systems Nederland B.V., 2020) after a 180-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
- Apr 28, 2025
- Review
- 180 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 deviceK243376 uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK253726 uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd. · 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 deviceK243376 uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd. · 2025
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K253726uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd. · 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) | K243376 | uAngio AVIVA CX | Shanghai United Imaging Healthcare Co., Ltd. | 2025 | — |
| +1 | K253726 | uAngio AVIVA CX | Shanghai United Imaging Healthcare Co., Ltd. | 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…CFR 892.1650 Review Panel: Radiology 4. Identification of Predicate Device(s) Predicate Device Trade/Device Name: Azurion R2.1 510(k) Number: K200917 Manufacturer: Philips Medical Systems Nederland B.V. Regulatory Information Classification Name: Image-intensifie… | 2020 |
| † | K201583 | SmartCT R1.0 | 2021 |
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 |
|---|---|---|---|
| K253726 | uAngio AVIVA CX | 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, K253726 (Shanghai United Imaging Healthcare Co., Ltd., 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 system is used to perform image guidance in diagnostic, intervention and surgical procedures. Procedures that can be performed with the system include cardiac angiography, neuro-angiography, vascular and non-vascular angiography, rotational angiography and whole body radiographic/fluoroscopic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243376 · printed Nov 4, 2026
Cite this page
510(k) Report. “K243376: uAngio AVIVA CX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K243376
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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