510(k) K033486 ยท OWB Interventional Fluoroscopic X-Ray System
GE PRECISION MPI
| Applicant | Nrt-Nordisk Rontgen Teknik A/S, Hasselager, DK |
| Decision | Substantially Equivalent, Nov 19, 2003 |
| Received | Nov 4, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033486
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 24, 2016 | Regulatory Insight, Inc GE Precision MPi is an all-digital multipurpose tilt-C x-ray system, intended for a multitude of diagnostic procedures, including radiology, fluoroscopy, interventional procedures, vascular and non-va Terminated |
OWB | None listed |
| Jul 20, 2015 | GE Healthcare GE Healthcare, Precision MPi fluoroscopic imaging systems. Terminated |
JAA | None listed |
| Feb 3, 2014 | GE Healthcare, LLC GE Healthcare Precision 500D, Precision MPI & Precision RXI X-ray imaging systems.
The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic Terminated |
OWB | None listed |
| Sep 29, 2009 | NRT - Nordisk Rontgen Teknik A/S Celex/GE Precision MPi, REF no.: 02980000
Is an all-digital multipurpose tilt-C X-ray system, intended for a multitude of diagnostic procedures, including: R&F, radiology, fluoroscopy, interventional Terminated |
JAA | None listed |
| Sep 19, 2008 | GE Healthcare GE Precision MPi, model 5126893. GE Medical Systems - Americas, Milwaukee, USA
The product is used to generate radiographic and fluoroscopic images of human anatomy, perform interventional procedures Terminated |
JAA | None listed |
| Sep 19, 2008 | GE Healthcare GE Precision MPi, model 2385125. GE Medical Systems - Americas, Milwaukee, USA
The product is used to generate radiographic and fluoroscopic images of human anatomy, perform interventional procedures Terminated |
JAA | None listed |
| Sep 19, 2008 | GE Healthcare GE Precision MPi, model 2398238. GE Medical Systems - Americas, Milwaukee, USA
The product is used to generate radiographic and fluoroscopic images of human anatomy, perform interventional procedures Terminated |
JAA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.