OEC BRIVO 865 ADVANCE, OEC BRIVO 785 ESSENTIAL, AND OEC BRIVO 715 PRIME— 510(k) K123603
Substantially EquivalentGe Healthcare Surgery GE Oec Medical Systems, Inc.
FDA 510(k) clearance K123603 for OEC BRIVO 865 ADVANCE, OEC BRIVO 785 ESSENTIAL, AND OEC BRIVO 715 PRIME, Substantially Equivalent on 2013-05-17. Applicant: Ge Healthcare Surgery GE Oec Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Ge Healthcare Surgery GE Oec Medical Systems, Inc.
- Product code
- Code OXO
- Device class
- Class 2
- Regulation
- 21 CFR 892.1650
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Salt Lake City, UT, US
Recent devices under product code OXO
view allMore clearances from Ge Healthcare Surgery GE Oec Medical Systems, Inc.
view allAdverse events under product code OXO
product code OXO- Death
- 6
- Injury
- 163
- Malfunction
- 2,099
- Other
- 1
- Total
- 2,269
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 K123603
K-number listed on FDA's recall record- Z-0071-2017 — OEC Brivo 715 Prime, OEC Brivo 785 Essential, OEC Brivo 865 Advance Product Usage: The OEC Brivo Mobile C-Arm X-Ray Products are designed to provide digital spot film imaging and fluoroscopic image guidance for all adult and pediatric populations for orientations between patient anatomy and surgical instruments. The product is used for general surgical applications and musculoskeletal procedures to visualize, for example, implant localizations or needle positions for aspirations, injections or biopsy. The OEC Brivo is not indicated for interventional use.
- Z-0840-2015 — GE OEC Brivo 715 Prime Mobile C-Arm X-Ray Product Used for general surgical applications and musculoskeletal procedures to visualize.
- Z-0841-2015 — GE OEC Brivo 865 Plus Mobile C-Arm X-Ray Product Used for general surgical applications and musculoskeletal procedures to visualize.
- Z-1638-2015 — GE OEC Brivo 865 plus, Mobile X-ray system laser aimer assemblies (part number 520002DW)
- Z-0066-2014 — GE Brivo OEC715/785/865 C-Arm, Models: 715 Prime, 785 Essential, and 865 Plus. The QEC Brivo Mobile C-Arm X-Ray Products are designed to provide digital spot film imaging and fluoroscopic image guidance for all adult and pediatric populations for orientations between patient anatomy and surgical instruments. The product is used for general surgical applications and musculoskeletal procedures to visualize, for example, implant localizations or needle positions for aspirations,injections or biopsy.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K123603.
Data sourced from openFDA. This site is unofficial and independent of the FDA.