Atlas FDA

MX8000 IDT CT SYSTEM

FDA 510(k) clearance K012009 · decided 2001-09-13

Clearance details

K-number
K012009
Device name
MX8000 IDT CT SYSTEM
Applicant
Marconi Medical Systems, Inc.
Decision
Substantially Equivalent
Date received
2001-06-27
Decision date
2001-09-13
Days to decision
78 days
Clearance type
Traditional
Product code
JAK
Device class
2
Regulation number
892.1750
Medical specialty
Radiology
Advisory committee
Radiology
Location
Cleveland, OH, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Philips CT systems labeled as the following: 1. Brilliance 16 Power, Model Number: 728240. recall (Z-2596-2025)Philips North America Llc2025-09-19
Brilliance CT 16 Slice Air (Uninterruptible Power Supply (UPS) accessory devices) Computed recall (Z-1765-2015)Philips Medical Systems (Cleveland) Inc2015-06-11
Brilliance CT 6 Slice Air (Uninterruptible Power Supply (UPS) accessory devices) Computed recall (Z-1766-2015)Philips Medical Systems (Cleveland) Inc2015-06-11
Diamond Select Brilliance CT 16 (Uninterruptible Power Supply (UPS) accessory devices) Com recall (Z-1793-2015)Philips Medical Systems (Cleveland) Inc2015-06-11
Brilliance CT 16 Power. Computed Tomography X-ray systems intended to produce cross-sectio recall (Z-1651-2015)Philips Medical Systems (Cleveland) Inc2015-05-22
Brilliance CT 16 Water. Computed Tomography X-ray systems intended to produce cross-sectio recall (Z-1652-2015)Philips Medical Systems (Cleveland) Inc2015-05-22
Brilliance CT 16 Air. Computed Tomography X-ray systems intended to produce cross-sectiona recall (Z-1653-2015)Philips Medical Systems (Cleveland) Inc2015-05-22
Brilliance CT 10 Air. Computed Tomography X-ray systems intended to produce cross-sectiona recall (Z-1654-2015)Philips Medical Systems (Cleveland) Inc2015-05-22
Brilliance CT 6 Air. Computed Tomography X-ray systems intended to produce cross-sectional recall (Z-1655-2015)Philips Medical Systems (Cleveland) Inc2015-05-22
Various Brilliance and Ingenuity Computed Tomography X-ray systems; one unit per package P recall (Z-0979-2015)Philips Medical Systems (Cleveland) Inc2015-01-15
IntelliSpace Portal (ISP) DX/HX/EX, IntelliSpace Portal (ISP) IX, and IntelliSpace Portal recall (Z-2237-2014)Philips Medical Systems (Cleveland) Inc2014-08-14
Philips Medical Systems Computed Tomography X-ray systems (Brilliance CT series, iCT, iCT recall (Z-1722-2014)Philips Medical Systems (Cleveland) Inc2014-06-04
IntelliSpace Portal (ISP), (ISP DX/HX/EX, Model number 881001; ISP IX, Model number 881030 recall (Z-1678-2014)Philips Medical Systems (Cleveland) Inc2014-06-02
Brilliance CT 16, Brilliance CT 64, Brilliance CT Big Bore Oncology, Brilliance CT Big Bor recall (Z-1461-2014)Philips Medical Systems (Cleveland) Inc2014-04-16
Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology and Brilliance CT 16 (Ai recall (Z-0013-2014)Philips Medical Systems (Cleveland) Inc2013-10-17
Brilliance CT 6, M/N 728256; Brilliance CT 16 M/N 728246; Brilliance CT 40, M/N 728235 & B recall (Z-2210-2013)Philips Medical Systems (Cleveland) Inc2013-09-16
Brilliance CT 16-Slice Water, System Code: 728245; Brilliance CT 10-Slice Water, System Co recall (Z-1338-2013)Philips Medical Systems (Cleveland) Inc2013-05-20
Brilliance 6, 10, 16, 40, 64, Big Bore and the iCT, iCT SP, Ingenuity CT and MX8000 Dual v recall (Z-0945-2013)Philips Medical Systems (Cleveland) Inc2013-03-13
Philips Medical Systems, Extended Brilliance Workspace (EBW) X-Ray Scanners, Model #728260 recall (Z-0881-2013)Philips Medical Systems (Cleveland) Inc2013-02-26
Computed Tomography X-Ray Systems, (Brilliance 6, Brilliance 16, MX8000 Dual v. Exp, GEMIN recall (Z-2451-2012)Philips Medical Systems (Cleveland) Inc2012-09-25
The Brilliance CT 16 System Product Usage: The Brilliance 16 is a Whole Body Computed Tomo recall (Z-2404-2012)Philips Medical Systems (Cleveland) Inc2012-09-19
The Brilliance 6, 10, 16, 40, 64 and CT Big Bore are Computed Tomography X-Ray Systems The recall (Z-2245-2012)Philips Medical Systems (Cleveland) Inc2012-08-22
Philips Brilliance 6, 16, 40, 64, Big Bore, iCT and iCT SP are Computed Tomography X-Ray S recall (Z-2035-2012)Philips Medical Systems (Cleveland) Inc2012-07-19
Intellispace Portal software Product Usage: Intellispace Portal is a multimodality thin-cl recall (Z-2000-2012)Philips Medical Systems (Cleveland) Inc2012-07-12
IntelliSpace Portal software and Extended Brillance Workspace software Intellispace Portal recall (Z-1987-2012)Philips Medical Systems (Cleveland) Inc2012-07-11
Intellispace Portal software. Intellispace Portal is a multimodality thin client applicati recall (Z-1988-2012)Philips Medical Systems (Cleveland) Inc2012-07-11
Brilliance 16 - Model #728246, CT Scanning System is subject to recall/correction Product recall (Z-1690-2012)Philips Medical Systems (Cleveland) Inc2012-05-30
Brilliance 40 - Model #72835, and Brilliance 64 - Model #728231, and Ingenuity - Model #72 recall (Z-1691-2012)Philips Medical Systems (Cleveland) Inc2012-05-30
Brilliance Big Bore - Model #728243, and - Model #728244, CT Scanning System is subject to recall (Z-1692-2012)Philips Medical Systems (Cleveland) Inc2012-05-30
Brilliance iCT - Model #728306, and Brilliance iCT SP - Model #728311, CT Scanning System recall (Z-1693-2012)Philips Medical Systems (Cleveland) Inc2012-05-30
Extended Brilliance Workstation-NM (EBW-NM) with software version 1.0P, 1.1.1A, 1.5H, 1.5. recall (Z-0182-2012)Philips Medical Systems2011-11-10
Extended Brilliance Workstation (EBW) a component of the Computed Tomography X-Ray System recall (Z-1819-2011)Philips Medical Systems (Cleveland) Inc2011-03-24
Vertical Brake Hubs of the Computed Tomography X-Ray Systems under the following Brands an recall (Z-1669-2011)Philips Medical Systems (Cleveland) Inc2011-03-16
Computed Tomography X-Ray System MX 8000 IDT 16; Model # 728120; Serial #'s: 2513, 2518, 3 recall (Z-0133-2011)Philips Medical Systems (Cleveland) Inc2010-10-22
Dental Application on the Extended Brilliance Workspace v4.0 and v4.0.1. Model #4550112026 recall (Z-1568-2009)Philips Medical Systems (Cleveland) Inc2009-07-06
Vertical drive brake (on patient supports). Used on certain Philips Medical Systems MX ser recall (Z-0597-2009)Philips Medical Systems (Cleveland) Inc2009-01-16
Respiratory Gating System which includes: Pulmonary Digital Assembly Kit and Pulmonary Too recall (Z-0132-2009)Philips Medical Systems (Cleveland) Inc2008-10-28
Philips Medical Systems, Cardiac Viewer or Pulmonary Viewer Application that can run on al recall (Z-0366-2008)Philips Medical Systems (Cleveland) Inc2007-12-29
Extended Brilliance Workspace Imaging Workstation. An independent diagnostic viewing and p recall (Z-0889-06)Philips Medical Systems (Cleveland) Inc2006-05-19
Brillance 16, 10, and 6 configuration (watercooled version) using 1.0, 1.1, 1.2, 1.2.2, or recall (Z-1411-05)Philips Medical Systems (Cleveland) Inc2005-08-30
Extended Brilliance Workspace using 1.x or 2.x software. recall (Z-1415-05)Philips Medical Systems (Cleveland) Inc2005-08-30
MxView using version 5.0, 5.0.1, or 4.1 software. recall (Z-1416-05)Philips Medical Systems (Cleveland) Inc2005-08-30
Philips MX8000 IDT CT Scanner System, 10 & 16 slice images. recall (Z-0786-04)Philips Medical Systems (Cleveland) Inc2004-07-20
Philips Brilliance CT Scanner System, 6, 10 & 16 slice images. recall (Z-0787-04)Philips Medical Systems (Cleveland) Inc2004-07-20
Philips MX8000 IDT CT Scanner, utilizing V2.1 software. recall (Z-0835-03)Philips Medical Systems (Cleveland) Inc2003-05-15