510(k) K132027 ยท OWB Interventional Fluoroscopic X-Ray System
OEC 9800 PLUS
| Applicant | Ge Oec Medical Systems, Inc., Salt Lake City UT, US |
| Decision | Substantially Equivalent, May 1, 2014 |
| Received | Jul 1, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K132027
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 22, 2025 | GE Medical Systems, LLC GE HealthCare OEC 9800. Open, Classified |
OWB | None listed |
| Dec 18, 2024 | GE OEC Medical Systems, Inc OEC 9800 REF
Image-Intensified Fluoroscopic X-Ray System, Mobile. The Series OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interve Open, Classified |
OXO | None listed |
| Jul 31, 2023 | GE OEC Medical Systems, Inc OEC 9800 Systems with 9-inch Image Intensifier Open, Classified |
OWB | None listed |
| Jul 31, 2023 | GE OEC Medical Systems, Inc Field Upgrade Kits: P/N 5451208 RIU, 9 INCH, TOSHIBA; P/N 5485304 SERVICE PART, IMAGE INTENSIFIER, 9 INCH, TOSHIBA; P/N 5761613 SERVICE PART, IMAGE INTENSIFIER, 9 INCH - used with OEC Flexiview 8800, Open, Classified |
OXO | None listed |
| Aug 27, 2020 | Ge Healthcare The OEC 9900 C-Arm is designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include chola Open, Classified |
RCC | None listed |
| Jan 20, 2017 | GE OEC Medical Systems, Inc OEC 9800. MDL Numbers: D222250, D141598 Terminated |
OWB | None listed |
| Jan 9, 2017 | GE OEC Medical Systems, Inc OEC 9800. MDL Numbers: D222250, D141598
The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applic Terminated |
OWB | None listed |
| Nov 7, 2014 | GE OEC Medical Systems, Inc Series OEC 9800.
The Series OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient,during diagnostic, surgical and interventional procedures. Terminated |
OWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.