510(k) K993090 ยท KPR System, X-Ray, Stationary
SILHOUETTE FC
| Applicant | Ge Medical Systems, Inc., Waukesha WI, US |
| Decision | Substantially Equivalent, Oct 1, 1999 |
| Received | Sep 16, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K993090
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 25, 2024 | GE Healthcare (China) Co., Ltd. GE Proteus XR/A radiographic system Open, Classified |
KPR | None listed |
| Aug 26, 2024 | GE Healthcare (China) Co., Ltd. GE Healthcare Proteus XR/a, stationary X-Ray System, Model/Catalog Numbers:
1) 2259973;
2) 2259988;
3) 2266999;
4) 2373519;
5) 2379827;
6) 5729352;
7) 2259973-1;
8) 2259973-2;
9) 2259973-3; Open, Classified |
KPR | None listed |
| Sep 20, 2019 | GE Healthcare, LLC Proteus XR/a (SlOK : K993090) Open, Classified |
KPR | None listed |
| Jun 10, 2019 | GE Healthcare, LLC Proteus XR/a
The Proteus XR/a radiographic system offers the flexibility to choose a configuration based upon your specific requirements. The system provides exceptional image quality, high frequenc Terminated |
KPR | None listed |
| Mar 6, 2015 | GE Healthcare GE Healthcare Proteus XR/a with wall stand model number 2260354.
Intended for use in generating radiographic images of human anatomy in all general purpose diagnostic procedures. This device is not i Terminated |
KPR | None listed |
| Jan 12, 2015 | GE Healthcare GE Healthcare, Proteus XR/a with wall stand model number 600-0301. Terminated |
KPR | None listed |
| Jul 2, 2014 | GE Healthcare, LLC GE Healthcare, Proteus XR/a.
Proteus XR/a Intended Use: Is intended for use in generating radiographic images of human anatomy in all general purpose diagnostic procedures. This device is not intende Terminated |
KPR | None listed |
| Jun 8, 2012 | General Electric Med Systems LLC GE Proteus XR/a Radiographic System. GE Medical Systems-Americas Milwaukee, WI.
Model Number: 2259988.
Product is indicated for use in generating radiographic images of human anatomy in all general- Terminated |
KPR | None listed |
| Dec 16, 2009 | GE Medical Systems, LLC GE Healthcare Proteus XR/a. Model # 2259988.
GE Healthcare, 3000 North Grandview, Waukesha, WI 53188.
The Silhouette FC is indicated for use in generating radiographic images of human anatomy in all Terminated |
KPR | None listed |
| Sep 30, 2008 | GE Healthcare GE Healthcare Proteus XR/a Eclipse Collimator model # 2379827. Terminated |
KPR | None listed |
| Jun 10, 2008 | GE Healthcare GE Healthcare Proteus XR/a Radiographic X-ray System, Model Number 2259976; previously marketed as the Silhouette FC, GE Healthcare, Waukesha, WI 53188. Terminated |
KPR | None listed |
| Sep 25, 2007 | General Electric Med Systems LLC GE Healthcare Proteus XR/a General Purpose Radiographic System, Models 2259973-4 and 2380179 containing Proteus Operator Console model# 2259976. Terminated |
KPR | None listed |
| Feb 14, 2006 | General Electric Med Systems LLC Proteus XR/a Radiographic X-ray System, models 2259973-1, 2259973-2, 2259973-3, 2259973-4. The system consists of a radiographic table, a overhead tube suspension, high frequency generator and power Terminated |
KPR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.