510(k) K002016 ยท OWB Interventional Fluoroscopic X-Ray System
PHILIPS INTEGRIS ALLURA
| Applicant | Philips Medical Systems North America, Inc., Da Best, NL |
| Decision | Substantially Equivalent, Sep 6, 2000 |
| Received | Jul 3, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002016
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 30, 2024 | Philips North America Integris-Allura IGTS Fixed Systems Open, Classified |
OWB | None listed |
| Sep 18, 2024 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. 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 72201 Open, Classified |
OWB | None listed |
| Dec 30, 2019 | Philips North America, LLC Integris Allura 15 & 12, monoplane (system code 722043) and biplane (system code 722044) Terminated |
OWB | None listed |
| Dec 30, 2019 | Philips North America, LLC Integris Allura 9, system codes 722018
722021 Terminated |
OWB | None listed |
| Jan 30, 2016 | Philips Electronics North America Corporation 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 All Terminated |
OWB | None listed |
| Jan 30, 2016 | Philips Electronics North America Corporation 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 Al Terminated |
OWB | None listed |
| Jan 30, 2016 | Philips Electronics North America Corporation 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 Terminated |
OWB | None listed |
| Jan 30, 2016 | Philips Electronics North America Corporation 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 sy Terminated |
OWB | None listed |
| Oct 9, 2014 | Philips Medical Systems, Inc. Philips Healthcare Integris Allura 15 -12 Fluoroscopy x ray system Terminated |
OWB | None listed |
| Jan 25, 2007 | Philips Medical Systems North America Co. Phillips Philips Integris Allura x-ray systems angiographic - Allura 9 F/C (floor and ceiling models). A mono-plane analog Allura with a 9' Image Intensifier Terminated |
IZI | None listed |
| Nov 29, 2005 | Philips Medical Systems North America Co. Phillips AD5 table for use with Integris and Integris Allura x-ray systems Terminated |
IZI | None listed |
| Nov 29, 2005 | Philips Medical Systems North America Co. Phillips AD6 table for use with Integris and Integris Allura x-ray systems. The AD6 is the tilt version. Terminated |
IZI | None listed |
| Aug 31, 2005 | Philips Medical Systems North America Co. Phillips Interis Allura BiPlane X-Ray System Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.