The Implant Files -
International Medical Devices Database
- About this investigation
- International Medical Devices Database
- Tell us your story
- Resources for patients
- Reporting partners
- Video introduction
Stories - Patients harmed by medical devices
- Europe, a device gateway to the world
- History of the industry
- The Medtronic way
- Ruptured trust and breast implants
- Heart device raises risk questions
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Model / Serial
System : S/N : Model: 722003 30 Allura Xper FD10 722010 670 Allura Xper FD10 722011 167 Allura Xper FD10/10 722012 1951 Allura Xper FD20 722012 536 Allura Xper FD21 722012 504 Allura Xper FD22 722012 748 Allura Xper FD23 722012 536 Allura Xper FD24 722012 579 Allura Xper FD25
- Product Classification
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Device Class
2
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Implanted device?
No
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Distribution
Worldwide Distribution - US Nationwide and the countries of: Canada,Australia, Austria, Brazil, Chile, China, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, South Africa, Spain, Switzerland and United Kingdom.
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Product Description
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 Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, interventional procedures (such as PTCA, stent placement, embolization and thrombolysis and atherectomics), pacemaker Implantations and electrophysiology (EP). Use of the Allura Xper series system in the OR environment is restricted; the system should only be used for endo-vascular procedures. The Philips Integris Allura 9F is intended for diagnostic cardiovascular, vascular and interventional procedures
- Manufacturer
- 1 Event
Manufacturer
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Manufacturer Address
Philips Medical Systems, Inc., 3000 Minuteman Rd, Andover MA 01810-1032
- Manufacturer Parent Company (2017)
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Source
USFDA
79 devices with a similar name
Learn more about the data here
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Model / Serial
Code 728306, SN# 100776, UDI: (01)00884838059474(21)100776; 100778, UDI: (01)00884838059474(21)100778; 100779, UDI: (01)00884838059474(21)100779; 100780, UDI: (01)00884838059474(21)100780; 100781, UDI: (01)00884838059474(21)100781; 100782, UDI: (01)00884838059474(21)100782; 100783, UDI: (01)00884838059474(21)100783; 100784, UDI: (01)00884838059474(21)100784; 100785, UDI: (01)00884838059474(21)100785; 100787, UDI: (01)00884838059474(21)100787; 100790, UDI: (01)00884838059474(21)100790; 100791, UDI: (01)00884838059474(21)100791; and 100794, UDI: (01)00884838059474(21)1007.
- Product Classification
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Device Class
2
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Implanted device?
No
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Distribution
Worldwide Distribution -- US, Argentina, China, Republic of Korea, Russian Federation, Slovakia, Turkey, and United Kingdom. 4 in US, (1 military), 14 foreign accounts
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Product Description
Brilliance iCT || Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.
- Manufacturer
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Model / Serial
Brilliance iCT - 728306 Devices manufactured 03/05/2009 to present.
- Product Classification
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Device Class
2
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Implanted device?
No
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Distribution
107 domestic accounts 15 US Govt accounts 682 Foreign Accounts 3 Mexico accounts 12 Canada accounts
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Product Description
Philips Healthcare Brilliance iCT computed tomography x-ray system
- Manufacturer
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Model / Serial
Brilliance iCT SP - 728311 Devices manufactured 03/05/2009 to present.
- Product Classification
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Device Class
2
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Implanted device?
No
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Distribution
107 domestic accounts 15 US Govt accounts 682 Foreign Accounts 3 Mexico accounts 12 Canada accounts
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Product Description
Philips Healthcare Brilliance iCT SP computed tomography x-ray system
- Manufacturer
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Model / Serial
IQon Spectral CT 728332 Devices manufactured 03/05/2009 to present.
- Product Classification
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Device Class
2
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Implanted device?
No
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Distribution
107 domestic accounts 15 US Govt accounts 682 Foreign Accounts 3 Mexico accounts 12 Canada accounts
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Product Description
Philips Healthcare IQon Spectral CT computed tomography x-ray system
- Manufacturer
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Model / Serial
Code 728231, SN # 10655
- Product Classification
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Device Class
2
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Implanted device?
No
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Distribution
Worldwide Distribution -- US, Argentina, China, Republic of Korea, Russian Federation, Slovakia, Turkey, and United Kingdom. 4 in US, (1 military), 14 foreign accounts
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Product Description
Brilliance 64, (Code 728231) || Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.
- Manufacturer