510(k) K971365 ยท IZI System, X-Ray, Angiographic
PHILIPS INTEGRIS H5000
| Applicant | Philips Medical Systems North America, Inc., Shelton CT, US |
| Decision | Substantially Equivalent, May 14, 1997 |
| Received | Apr 14, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971365
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 30, 2019 | Philips North America, LLC Poly G Integris H5000, System code 72246 Terminated |
IZI | None listed |
| Jan 30, 2016 | Philips Electronics North America Corporation INTEGRIS H3000; Model Number: 72238
The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane Terminated |
IZI | None listed |
| Jan 30, 2016 | Philips Electronics North America Corporation INTEGRIS HM3000; Model Number: 72239
The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane Terminated |
IZI | None listed |
| Jan 30, 2016 | Philips Electronics North America Corporation INTEGRIS BN/BV3000; Model Number: 72240
The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Bipl Terminated |
IZI | None listed |
| Jan 30, 2016 | Philips Electronics North America Corporation INTEGRIS BH3000; Model Number: 72242
The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane Terminated |
IZI | None listed |
| Jan 30, 2016 | Philips Electronics North America Corporation INTEGRIS V3000; Model Number: 72243, 72244, 72245
The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS All Terminated |
IZI | None listed |
| Jan 30, 2016 | Philips Electronics North America Corporation INTEGRIS BV3000 MONO; Model Number: 72241
The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Bi Terminated |
IZI | None listed |
| Feb 3, 2015 | Philips Medical Systems, Inc. Philips Healthcare Allura Xper Series:
Allura Xper FD10
Allura Xper FD10/10
Allura Xper FD20
Allura Xper FD21
Allura Xper FD22
Allura Xper FD23
Allura Xper FD24
Allura Xper FD25
Product Usage:
The A Terminated |
OWB | None listed |
| Feb 3, 2015 | Philips Medical Systems, Inc. Philips Healthcare Allure BiPlane Series:
Model
722013 Allura Xper FD20 BIPLANE R7.6
722013 Allura Xper FD20 BIPLANE R7.7
722013 Allura Xper FD20 BIPLANE R7.8
722013 Allura Xper FD20 BIPLA Terminated |
OWB | None listed |
| Feb 3, 2015 | Philips Medical Systems, Inc. Philips Healthcare INTEGRIS cardio system
Model : 722121
Product Usage:
The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, i Terminated |
OWB | None listed |
| Feb 3, 2015 | Philips Medical Systems, Inc. Philips Healthcare INTEGRIS vascular System
Model : 722122
Product Usage:
The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, Terminated |
OWB | None listed |
| Feb 3, 2015 | Philips Medical Systems, Inc. Philips Healthcare INTEGRIS H5000F/Allura 9F
Model : 722017
Product Usage:
The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics Terminated |
OWB | None listed |
| Feb 3, 2015 | Philips Medical Systems, Inc. Philips Healthcare Xper cardio systems
Model : 722123
Product Usage:
The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, inte Terminated |
OWB | None listed |
| Feb 3, 2015 | Philips Medical Systems, Inc. Philips Healthcare Xper vascular system
Model : 722124
Product Usage:
The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, in Terminated |
OWB | None listed |
| Feb 3, 2015 | Philips Medical Systems, Inc. Philips Healthcare Xper cardio systems R7.6
Model : 722133
Product Usage:
The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, Terminated |
OWB | None listed |
| Feb 3, 2015 | Philips Medical Systems, Inc. Philips Healthcare Xper vascular systems R7.6
Model : 722134
Product Usage:
The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics Terminated |
OWB | None listed |
| Jul 20, 2004 | Philips Medical Systems Sales & Service Region No. America Clea Stand Ceiling used with the Integris X-Ray System H5000, Allura 12/15, Allura 9C Terminated |
EHD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.