ClearanceBrief
510(k) K151000 ยท OWB Interventional Fluoroscopic X-Ray System

O-Arm O2 Imaging System

ApplicantMedtronic, Inc., Littleton MA, US
DecisionSubstantially Equivalent, Aug 6, 2015
ReceivedApr 15, 2015
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K151000

DateFirm and productCodeLinked 510(k)
Jun 6, 2024Medtronic Navigation, Inc.-Littleton
O-arm O2 Imaging System-Mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients. Product Number: BI70002000
Open, Classified		 OWBNone listed
Aug 24, 2023Medtronic Navigation, Inc.-Littleton
The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients weighing 60 lbs. or greater and having an abdominal thickness greater
Open, Classified		 OWBNone listed
Dec 31, 2019Medtronic Navigation, Inc.-Littleton
O-arm" O2 Imaging System, Product Number/CFN: BI-700-02000
Terminated		 OWBNone listed
Sep 30, 2017Medtronic Navigation, Inc.-Littleton
O-arm O2 interventional fluoroscopic x-ray system; Catalog Number: B1-700-02000 The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatri
Terminated		 OWBNone listed
Oct 11, 2016Medtronic Navigation, Inc.-Littleton
Medtronic Navigation O-arm O2 Surgical Imaging System Product Catalog Number: BI-700-02000 Product Usage: The O-arm Surgical Imaging System is a multi-dimensional surgical imaging platform that is de
Terminated		 OWBNone listed
Mar 17, 2016Medtronic Navigation, Inc.-Littleton
Medtronic Navigation O-arm 02 surgical x-ray imaging system
Terminated		 OWBNone listed
Mar 8, 2016Medtronic Navigation, Inc.
Medtronic 0-arm 02 Imaging System Catalog Number: Bl-700-02000 The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physi
Terminated		 OWBNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.