Medical device licence · 79575 · Class 3
BRIGHTVIEW XCT IMAGING SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed April 23, 2009. It is in Health Canada’s list of active licences.
- Licence number
- 79575
- Licence holder
- Philips Medical Systems Nederland B.V.Orange Village, OH, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- April 23, 2009
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BRIGHTVIEW XCT IMAGING SYSTEM - ASSY, X-RAY DETECTOR (FLAT PANEL)
- BRIGHTVIEW XCT IMAGING SYSTEM - BASE GANTRY
- BRIGHTVIEW XCT IMAGING SYSTEM - MODL, TABLE
- BRIGHTVIEW XCT IMAGING SYSTEM - TILT SYSTEM
- BRIGHTVIEW XCT IMAGING SYSTEM - UPGRADE KIT, BRIGHTVIEW X TO BRIGHTVIEW XCT
- BRIGHTVIEW XCT IMAGING SYSTEM - X-RAY GENERATOR ASSAY
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “brightview”. A notice may cover another product or only some lots: read it to see what it covers.
- BrightView XCT Imaging System and Gamma Camera SystemJanuary 5, 2024 · Physical medicine · Performance · Type I
- Brightview SystemDecember 22, 2023 · Radiology · Performance · Type II
- BrightView XCT Imaging System and Gamma Camera System (2019-06-02)June 28, 2019 · Medical devices · Medical devices · Type II
- Precedence System - 6 and 16 Slice, Brightview Gamma - Camera Sy. W/ 3/8" Crystal & Detector Caudal Cephalic Tilt, Xct Imaging System - Tilt System and Syst, Brightview X With Crystal, 3/8" (Upgradeable Version) (2017-12-21)January 8, 2018 · Medical devices · Medical devices · Type II
- BrightView Imaging Systems (2017-02-24)March 6, 2017 · Medical devices · Medical devices · Type I
- Brightview XCT Imaging System-Base Gantry (2017-02-06)February 27, 2017 · Medical devices · Medical devices · Type II
- Brightview XCT Imaging SystemJanuary 25, 2017 · Medical devices · Type III
- BrightView Imaging Systems (2016-05-25)June 16, 2016 · Medical devices · Medical devices · Type III
- BRIGHTVIEW GAMMA CAMERA AND XCT IMAGING SYSTEMS (2015-12-17)January 14, 2016 · Medical devices · Health products · Type III
- Brightview XCT Imaging System - Tilt System (2014-11-07)November 21, 2014 · Medical devices · Medical devices · Type III
- Brightview Gamma Camera Systems (2014-11-07)November 20, 2014 · Medical devices · Medical devices · Type II
- Brightview XCT Imaging System - Tilt System (2014-06-13)July 3, 2014 · Medical devices · Medical devices · Type II
- Brightview Gamma, XCT, and X Camera Systems (2013-12-24)January 24, 2014 · Medical devices · Medical devices · Type II
- Brightview XCT Imaging System-Tilt System (2013-09-04)September 27, 2013 · Medical devices · Medical devices · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.