510(k) K080048 ยท LNH System, Nuclear Magnetic Resonance Imaging
MSK EXTREME MR SCANNER, MODEL AA5000
| Applicant | Oni Medical Systems, Inc., Wilmington MA, US |
| Decision | Substantially Equivalent, Feb 6, 2008 |
| Received | Jan 8, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K080048
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 8, 2016 | GE Healthcare, LLC MSK 1.5T Extreme MR Scanner, a diagnostic imaging device Terminated |
LNH | None listed |
| May 1, 2013 | GE Healthcare, LLC MSK EXTREME MR SCANNER, MODEL AA5000
The intended for use as a diagnostic imaging device to produce axial, sagittal, coronal and oblique images of the internal structures of the leg (excluding the th Terminated |
LNH | None listed |
| Oct 26, 2011 | GE Healthcare, LLC GE HEALTHCARE, MSK 1.5T EXTREME MR SCANNER, MODEL AA5000.
The MSK Extreme TM MR Scanner is intended for use as a diagnostic imaging device to produce axial, sagittal, coronal and oblique images of th Terminated |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.