Allura Xper R9— 510(k) K162148

Clearance details

Applicant

Philips Medical Systems Nethrlands BV

Product code

Code OWB

Device class

Class 2

Regulation

21 CFR 892.1650

Advisory panel

Radiology

Date received

2016-08-01

Decision date

2016-11-23

Decision

Substantially Equivalent

Clearance type

Abbreviated

Location

Best Noord-Brabant, NL

• K253726 — uAngio AVIVA CX2026-08-21
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• K254205 — Zenition 302026-08-07
• K260607 — Shield System (Siemens 30x40)2026-07-31
• K253670 — SmartCT (R3.0 (L10))2026-07-10

• K153022 — Philips IntelliSpace Cardiovascular2015-11-18
• K150665 — Philips Spectral CT Applications2015-08-07
• K143606 — MultiBand SENSE2015-05-08
• K142708 — VERADIUS UNITY2014-10-22

Death

49

Injury

340

Malfunction

36,973

Total

37,362

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2476-2021 — The Azurion series (within the limits of the used 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.Class II·Terminated·Philips North America Llc·20210813
• Z-1145-2020 — VesselNavigator application used with Philips Azurion (Azurion 7 Series) Software R1.2 and R2.0, and Philips Allura Xper R9, upgraded to Azurion 1.2 M20. System codes: Azurion 7 B12 (722067), Azurion 3 B20 (722068), Azurion 7 M12 (722078), Azurion 7 M20 (722079), Field Extensions Azurion 7 series (722136), Allura Xper R9 (722303). The product is software, used during an endovascular intervention procedure.Class II·Terminated·Philips North America, LLC·20191223
• Z-0255-2018 — Azurion 3 M12, Azurion 3 M15, Allura R9 7 M12, Allura R9 M20, Azurion 7 M12, Azurion 7 M20 The Allura Xper series is intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs, stent placements, embolisations and thrombolysis. Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures ( such as PTCA, stent placing, atherectomies), pacemaker implantations, and electrophysiology (EP) Non-vascular interventions such as drainages, biopsies and vertebroplastics procedures The Azurion series (within the limits of the used 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.Class II·Terminated·Philips Electronics North America Corporation·20170818

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K162148.