510(k) K801320 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
SFX-90 TABLE/SPOTFILMER W/FLUORICON L200
| Applicant | General Electric Co., Mchenry IL, US |
| Decision | Substantially Equivalent, Jul 21, 1980 |
| Received | Jun 3, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K801320
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 22, 2017 | GE Healthcare, LLC Table Patient Step on RFX/SFX, Legacy, and Precision 500D systems Terminated |
IXR | None listed |
| Nov 21, 2016 | GE Healthcare, LLC SFX Terminated |
JAA | None listed |
| Jan 21, 2014 | GE Healthcare, LLC Video Monitor Suspensions that may be on the following Fluoroscopic and Radiographic X-Ray systems: Precision 500D, Legacy, Prestilix, Monitrol, RFX, SFX, Tilt-C, Prestige VH, Prestige SI, and Presti Terminated |
JAA | None listed |
| Oct 17, 2013 | GE Healthcare, LLC GE Healthcare, Precision 500D, Legacy, RFX, and SFX X.
This table is intended for use in a diagnostic X-ray system to support patients during general purpose radiological procedures in the horizonta Terminated |
JAA | None listed |
| Oct 27, 2008 | GE Healthcare Monitor suspensions used with Advantx Legacy, RFX Classical, SFX-90, Model # 46-240838G2, manufactured after March 8, 1985 for Advantx Legacy, RFX and SFX systems.
General-purpose radiographic system Terminated |
IZO | None listed |
| Jul 20, 2004 | General Electric Med Systems GE Single 15 inch TV Monitor Suspension with Rail, Model 46-240485P1, Catalog number B0256EH Terminated |
EAM | None listed |
| Jul 20, 2004 | General Electric Med Systems GE Single 15 inch TV Monitor Suspension for XT Bridge, Model 46-240485P2, Catalog Number B2056HA Terminated |
EAM | None listed |
| Jul 20, 2004 | General Electric Med Systems GE Single 20 inch TV Monitor Suspension with Rail, Model 46-240485P5, Catalog Number B2056EC Terminated |
EAM | None listed |
| Jul 20, 2004 | General Electric Med Systems GE Single 20 inch TV Monitor Suspension for XT Bridge, Model 46-240485P6, Catalog Number B2056EG Terminated |
EAM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.