510(k) K133674 ยท JAK System, X-Ray, Tomography, Computed
PHILIPS IQON SPECTRAL CT
| Applicant | Philips Healthcare (Cleveland), Cleveland OH, US |
| Decision | Substantially Equivalent, Nov 21, 2014 |
| Received | Nov 29, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133674
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 8, 2018 | Philips Medical Systems (Cleveland) Inc IQon Spectral CT - Model no. 728332, Computed Tomography X-Ray system
Product Usage:
Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstructio Terminated |
JAK | None listed |
| Jan 11, 2018 | Philips Medical Systems (Cleveland) Inc IQon Spectral CT with 4.7.2 software version.- Model 728332, a Philips Computed Tomography X-Ray System Terminated |
JAK | None listed |
| Nov 8, 2017 | Philips Medical Systems (Cleveland) Inc Philips Healthcare IQon Spectral CT computed tomography x-ray system Terminated |
JAK | None listed |
| Dec 16, 2016 | Philips Medical Systems (Cleveland) Inc IQon Spectral CT with software version 4.7.0
Product Usage:
The IQon Spectral CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstructio Terminated |
JAK | None listed |
| Nov 14, 2016 | Philips Medical Systems (Cleveland) Inc IQon Spectral CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes Terminated |
JAK | None listed |
| Oct 13, 2016 | Philips Medical Systems (Cleveland) Inc IQon Spectral CT Computed Tomography X-ray system, Model 728332 Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.