510(k) K010817 ยท JAK System, X-Ray, Tomography, Computed
MX8000 V5.0 CT SYSTEM
| Applicant | Philips Medical Systems (Cleveland), Inc., Cleveland OH, US |
| Decision | Substantially Equivalent, Jun 15, 2001 |
| Received | Mar 19, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010817
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 1, 2021 | Philips North America Llc Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems:
Model - MX8000
Models: 728120/728125/728201 Open, Classified |
JAK | None listed |
| May 22, 2015 | Philips Medical Systems (Cleveland) Inc MX8000 Dualv. EXP, 728130.
Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and Terminated |
JAK | None listed |
| Sep 26, 2014 | Philips Medical Systems (Cleveland) Inc Brilliance CT System 6/10/16/16P/40 configuration. No packaging, sold as single unit.
Computed tomography scanner intended to provide cross sectional images of the human body and visualization of Terminated |
JAK | None listed |
| Jun 4, 2014 | Philips Medical Systems (Cleveland) Inc Philips Medical Systems Computed Tomography X-ray systems (Brilliance CT series, iCT, iCT SP, Ingenuity CT, Ingenuity Core, Ingenuity Core128, Ingenuity Flex, and the MX8000 Dual v. EXP scanners) Terminated |
JAK | None listed |
| Mar 13, 2013 | Philips Medical Systems (Cleveland) Inc Brilliance 6, 10, 16, 40, 64, Big Bore and the iCT, iCT SP, Ingenuity CT and MX8000 Dual v. EXP are Computed Tomography X-Ray Systems.
These devices are Computed Tomography X-Ray Systems that are int Terminated |
JAK | None listed |
| Aug 1, 2011 | Philips Medical Systems (Cleveland) Inc Vertical Brake Hubs component of the Philips MX8000 Series Dual v. Exp. Computed Tomography System, Serial Numbers: 8008-8413, 80001-800022, Model #728130, 510 (k) #K010817.
Product Usag: The MX 800 Terminated |
KPS | None listed |
| Jan 16, 2009 | Philips Medical Systems (Cleveland) Inc Vertical drive brake (on patient supports). Used on certain Philips Medical Systems MX series and Brilliance series CT scanners.
The device is a vertical drive brake that controls the vertical posi Terminated |
KPS | None listed |
| Sep 26, 2007 | Philips Medical Systems (Cleveland) Inc Brilliance(a) CT 6 slice, Model #4535 670 73191.
Brilliance(a) CT 10 Slice, Model 4535 670 73181.
Brilliance 16 Slice, Model #4535 670 78851.
Brilliance CT 16 Power, Model #4535 670 23331.
Bri Terminated |
KPS | None listed |
| Aug 30, 2005 | Philips Medical Systems (Cleveland) Inc Brillance CT System, 16 Power configuration using version 1.2 or 1.2.1 software. Terminated |
JAK | None listed |
| Aug 30, 2005 | Philips Medical Systems (Cleveland) Inc Brillance CT System, 16, 10 and 6 configurations (air cooled version) using version 1.2 or 1.2.1software. Terminated |
JAK | None listed |
| Aug 30, 2005 | Philips Medical Systems (Cleveland) Inc MX8000 Dual v.EXP CT scanner using Version 2.5 software. Terminated |
JAK | None listed |
| May 15, 2003 | Philips Medical Systems (Cleveland) Inc Philips MX8000 Dual v. EXP CT Scanner, utilizing V2.0 software. Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.