PHILIPS INTEGRIS ALLURA— 510(k) K002016

Clearance details

Applicant

Philips Medical Systems North America, Inc.

Product code

Code OWB

Device class

Class 2

Regulation

21 CFR 892.1650

Advisory panel

Radiology

Date received

2000-07-03

Decision date

2000-09-06

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Da Best, NL

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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

• K102005 — ALLURA XPER OR TABLE SERIES2010-08-09
• K062233 — HEARTSTART MRX MONITOR/DEFIBRILLATOR2006-11-22
• K062283 — THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 INTELLIVUE PATIENT MONITORS2006-09-20
• K061052 — THE PHILIPS INTELLIVUE PATIENT MONITORS, MODELS MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP902006-05-26
• K050151 — MULTIDIAGNOST ELEVA2005-02-09

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-3167-2024 — System Name: 722044 INTEGRIS Allura 15-12 (biplane) 722030 Integris CV Cesar-Powerpack-Visub-Nicol 722021 INTEGRIS Allura 9 (biplane) 722018 Integris Allura 9 722017 Integris H5000 F / Allura 9F 722016 Integris H5000 C / Allura 9CClass II·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·20240822
• Z-0227-2024 — Integris-Allura IGTS Fixed SystemsClass II·Ongoing·Philips North America·20231004
• Z-1487-2020 — Integris Allura 15 & 12, monoplane (system code 722043) and biplane (system code 722044)Class II·Terminated·Philips North America, LLC·20191230
• Z-1488-2020 — Integris Allura 9, system codes 722018 722021Class II·Terminated·Philips North America, LLC·20191230
• Z-0726-2016 — INTEGRIS Allura 9 (biplane); Model Number: 722021 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura 12 & 15 system is intended for peripheral, abdominal, cerebral diagnostic and interventional angiography, neuro applications, cardiac applications and non-vascular interventionsClass II·Terminated·Philips Electronics North America Corporation·20151103
• Z-0727-2016 — INTEGRIS Allura 15-12 (mono); Model Number: 722043 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura 12 & 15 system is intended for peripheral, abdominal, cerebral diagnostic and interventional angiography, neuro applications, cardiac applications and non-vascular interventionsClass II·Terminated·Philips Electronics North America Corporation·20151103
• Z-0728-2016 — INTEGRIS Allura 15-12 (biplane); Product Code: 722044 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura 12 & 15 system is intended for peripheral, abdominal, cerebral diagnostic and interventional angiography, neuro applications, cardiac applications and non-vascular interventionsClass II·Terminated·Philips Electronics North America Corporation·20151103
• Z-0729-2016 — INTEGRIS CV; Model Number: 722030 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura 12 & 15 system is intended for peripheral, abdominal, cerebral diagnostic and interventional angiography, neuro applications, cardiac applications and non-vascular interventionsClass II·Terminated·Philips Electronics North America Corporation·20151103
• Z-0022-2015 — Philips Healthcare Integris Allura 15 -12 Fluoroscopy x ray systemClass II·Terminated·Philips Medical Systems, Inc.·20140808

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K002016.