OEC OLYMPUS MOBILE FLUOROSCOPY SYSTEM WITH INTEGRATED NAVIGATION
FDA 510(k) clearance K041931 · decided 2004-08-26
Clearance details
- K-number
- K041931
- Device name
- OEC OLYMPUS MOBILE FLUOROSCOPY SYSTEM WITH INTEGRATED NAVIGATION
- Applicant
- Ge Oec Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-07-19
- Decision date
- 2004-08-26
- Days to decision
- 38 days
- Clearance type
- Traditional
- Product code
- OWB
- Device class
- 2
- Regulation number
- 892.1650
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| GEHC OEC 9900 ESP-15 Elite C-Arm fluoroscopic X-ray system, GE Healthcare, Salt Lake City, recall (Z-0989-2007) | GE OEC Medical Systems, Inc | 2007-07-12 |
| GE OEC 9900 Elite Fluoroscopic X-ray System, GE Healthcare, Salt Lake City, Utah. recall (Z-0848-2007) | GE OEC Medical Systems, Inc | 2007-06-30 |
| GE OEC 9900 Elite Fluoroscopy System with Integrated Navigation,GE OEC Medical Systems Inc recall (Z-0041-2007) | GE OEC Medical Systems, Inc | 2006-10-25 |
| OEC 9900 Elite Fluoroscopy System, Catalog No. 887208 and 887210, GE OEC Medical Systems, recall (Z-0042-2007) | GE OEC Medical Systems, Inc | 2006-10-14 |
| GE OEC 9900 Elite Digital Mobile C-Arm X-ray system, GE OEC Medical Systems Inc. recall (Z-1301-06) | GE OEC Medical Systems, Inc | 2006-09-30 |