Azurion 722230
GUDID 00884838116733
Monoplane Interventional X-Ray System. A floor-mounted monoplane system with a 15-inch flat detector
Philips Medical Systems Nederland B.V.
Stationary angiographic x-ray system, digital| Primary Device ID | 00884838116733 |
| NIH Device Record Key | f4904e08-dd0a-428f-8ab7-4082f0c35d82 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Azurion |
| Version Model Number | Azurion 3 M15 |
| Catalog Number | 722230 |
| Company DUNS | 413819707 |
| Company Name | Philips Medical Systems Nederland B.V. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Operating and Storage Conditions
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 110 KiloPascal |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 110 KiloPascal |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 110 KiloPascal |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 110 KiloPascal |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 110 KiloPascal |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 110 KiloPascal |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 110 KiloPascal |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 110 KiloPascal |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 110 KiloPascal |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 110 KiloPascal |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 110 KiloPascal |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 110 KiloPascal |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 110 KiloPascal |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 110 KiloPascal |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 110 KiloPascal |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 110 KiloPascal |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 110 KiloPascal |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 110 KiloPascal |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 110 KiloPascal |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 110 KiloPascal |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 110 KiloPascal |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 110 KiloPascal |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 110 KiloPascal |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 110 KiloPascal |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 110 KiloPascal |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 110 KiloPascal |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 110 KiloPascal |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 110 KiloPascal |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 110 KiloPascal |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 110 KiloPascal |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00884838116733 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K200917
FDA Product Code
| JAA | System, x-ray, fluoroscopic, image-intensified |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-09-06 |
| Device Publish Date | 2023-08-29 |
On-Brand Devices [Azurion]
| 00884838085367 | Biplane Interventional X-Ray System with floor-mounted frontal stand (20-inch flat detector), ce |
| 00884838085350 | Biplane Interventional X-Ray System with floor-mounted frontal stand (12-inch flat detector), ce |
| 00884838085282 | Monoplane Interventional X-Ray System. A floor-mounted monoplane system with a 15-inch flat det |
| 00884838085275 | Monoplane Interventional X-Ray System. A floor-mounted monoplane system with a 12-inch flat det |
| 00884838085268 | Monoplane Interventional X-Ray System. A ceiling or floor-mounted monoplane system with a 20-inc |
| 00884838085251 | Monoplane Interventional X-Ray System. A ceiling or floor-mounted monoplane system with a 12-inc |
| 00884838116740 | Monoplane Interventional X-Ray System. A ceiling monoplane system with a 12-inch flat detector. |
| 00884838116733 | Monoplane Interventional X-Ray System. A floor-mounted monoplane system with a 15-inch flat dete |
| 00884838116726 | Monoplane Interventional X-Ray System. A floor-mounted monoplane system with a 12-inch flat dete |
| 00884838116801 | Biplane Interventional X-Ray System with floor-mounted frontal stand (20-inch flat detector), ce |
| 00884838116788 | Biplane Interventional X-Ray System with floor-mounted frontal stand (12-inch flat detector), ce |
| 00884838116771 | Monoplane Interventional X-Ray System. A ceiling or floor-mounted monoplane system with a 20-inc |
| 00884838116764 | Monoplane Interventional X-Ray System. A ceiling or floor-mounted monoplane system with a 12-inc |
| 00884838116757 | Monoplane Interventional X-Ray System. A ceiling or floor-mounted monoplane system with a 20-inc |
| 00884838099272 | Biplane Interventional X-Ray System with floor-mounted frontal stand (20-inch flat detector), ce |
| 00884838099265 | Biplane Interventional X-Ray System with floor-mounted frontal stand (12-inch flat detector), ce |
| 00884838099258 | Monoplane Interventional X-Ray System. A ceiling or floor-mounted monoplane system with a 20-inc |
| 00884838099241 | Monoplane Interventional X-Ray System. A ceiling or floor-mounted monoplane system with a 12-inc |
| 00884838099234 | Monoplane Interventional X-Ray System. A ceiling or floor-mounted monoplane system with a 20-inc |
| 00884838099227 | Monoplane Interventional X-Ray System. A ceiling or floor-mounted monoplane system with a 12-inc |
| 00884838099210 | Monoplane Interventional X-Ray System. A floor-mounted monoplane system with a 15-inch flat det |
| 00884838099203 | Monoplane Interventional X-Ray System. A floor-mounted monoplane system with a 12-inch flat det |
Trademark Results [Azurion]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AZURION 79162838 5051661 Live/Registered |
KONINKLIJKE PHILIPS N.V. 2015-03-04 |
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