OEC 9800 PLUS— 510(k) K132027
Substantially EquivalentGe Oec Medical Systems, Inc.
FDA 510(k) clearance K132027 for OEC 9800 PLUS, Substantially Equivalent on 2014-05-01. Applicant: Ge Oec Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Ge Oec Medical Systems, Inc.
- Product code
- Code OWB
- Device class
- Class 2
- Regulation
- 21 CFR 892.1650
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Salt Lake City, UT, US
Recent devices under product code OWB
view allMore clearances from Ge Oec Medical Systems, Inc.
view allAdverse events under product code OWB
product code OWB- Death
- 49
- Injury
- 340
- Malfunction
- 36,973
- Total
- 37,362
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K132027
K-number listed on FDA's recall record- Z-2341-2025 — GE HealthCare OEC 9800.
- Z-0706-2025 — 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 interventional procedures. Clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.
- Z-2276-2023 — OEC 9800 Systems with 9-inch Image Intensifier
- Z-2279-2023 — 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, OEC 9800, and OEC 9900 Systems
- Z-2872-2020 — 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 cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical-care and emergency room procedures. The GE OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures, and is also intended for cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, critical care and emergency room procedures.
- Z-1059-2017 — OEC 9800. MDL Numbers: D222250, D141598
- Z-0973-2017 — 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 application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.
- Z-0195-2015 — 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.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K132027.
Data sourced from openFDA. This site is unofficial and independent of the FDA.