510(k) K103483 ยท OUO Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
INGENUITY TF PET/MR
| Applicant | Philips Healthcare (Cleveland), Cleveland OH, US |
| Decision | Substantially Equivalent, Nov 23, 2011 |
| Received | Nov 26, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103483
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 31, 2015 | Philips Medical Systems (Cleveland) Inc Ingenuity TF PET/MR, Diagnostic Imaging System , Philips Medical Systems Terminated |
OUO | None listed |
| Jun 11, 2015 | Philips Medical Systems (Cleveland) Inc Ingenuity PET/MR (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems. Terminated |
OUO | None listed |
| May 28, 2015 | Philips Medical Systems (Cleveland) Inc Ingenuity TF Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI), 882380, Philips Medical Systems.
The device is a diagnostic imaging system for fixed installations that combines Terminated |
KPS | None listed |
| May 22, 2012 | Philips Medical Systems (Cleveland) Inc Ingenuity TF PET/MRI System v.3.7.1, 510(k) #K103483, Model #882380.
The device is a diagnostic imaging system for fixed installations that combines Positron Emission Tomography (PET) and Magnetic R Terminated |
OUO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.