PHILIPS INTEGRIS V5000 AND BV5000— 510(k) K973482
Substantially EquivalentPhilips Medical Systems North America, Inc.
FDA 510(k) clearance K973482 for PHILIPS INTEGRIS V5000 AND BV5000, Substantially Equivalent on 1997-11-10. Applicant: Philips Medical Systems North America, Inc.. Device class: 2.
Clearance details
- Applicant
- Philips Medical Systems North America, Inc.
- Product code
- Code IZI
- Device class
- Class 2
- Regulation
- 21 CFR 892.1600
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shelton, CT, US
Recent devices under product code IZI
view allMore clearances from Philips Medical Systems North America, Inc.
view all- K102005 — ALLURA XPER OR TABLE SERIES
- K062233 — HEARTSTART MRX MONITOR/DEFIBRILLATOR
- K062283 — THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 INTELLIVUE PATIENT MONITORS
- K061052 — THE PHILIPS INTELLIVUE PATIENT MONITORS, MODELS MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90
- K050151 — MULTIDIAGNOST ELEVA
Adverse events under product code IZI
product code IZI- Death
- 9
- Malfunction
- 5,312
- Total
- 5,321
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K973482
K-number listed on FDA's recall record- Z-0722-2016 — INTEGRIS H5000; Model Number: 72246 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 interventions
- Z-0723-2016 — INTEGRIS BH5000; Model Number: 72247 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 interventions
- Z-0724-2016 — INTEGRIS V5000: Model Number: 72248 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 interventions
- Z-0725-2016 — INTEGRIS BV5000: Model Number: 72249 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 interventions
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K973482.
Data sourced from openFDA. This site is unofficial and independent of the FDA.