510(k) K092564 ยท OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
O-ARM IMAGING SYSTEM
| Applicant | Medtronic Navigation, Inc. (Littleton), Littleton MA, US |
| Decision | Substantially Equivalent, Jun 17, 2010 |
| Received | Aug 20, 2009 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K092564
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 1, 2019 | Medtronic Navigation, Inc.-Littleton Medtronic 0-arm TM 1000 Imaging Systems: Bl-700-00027-XXX and B1-700-00028-XXX (where XXX indicates the system voltage):
Product Name Model#/ CFN
OARM ASSY 8170000027 SYSTEM PRODUCT BI70000027
OARM AS Terminated |
OXO | None listed |
| Aug 30, 2018 | Medtronic Navigation, Inc.-Littleton O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027 SYSTEM PRODUCT, Model Number Bl70000027
Product Usage:
The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3 Terminated |
OXO | None listed |
| Aug 30, 2018 | Medtronic Navigation, Inc.-Littleton O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027R SYS PRODUCT RWK, Model Number Bl70000027R
Product Usage:
The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic an Terminated |
OXO | None listed |
| Aug 30, 2018 | Medtronic Navigation, Inc.-Littleton O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027100 SYSTEM lOOV, Model Number Bl70000027100
Product Usage:
The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic an Terminated |
OXO | None listed |
| Aug 30, 2018 | Medtronic Navigation, Inc.-Littleton O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027100R SYSTEM lOOV RWK, Model Number Bl70000027100R
Product Usage:
The O-arm Imaging System is a mobile x-ray system designed for 2D fluorosco Terminated |
OXO | None listed |
| Aug 30, 2018 | Medtronic Navigation, Inc.-Littleton O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027120 SYSTEM 120V, Model Number Bl70000027120
Product Usage:
The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic an Terminated |
OXO | None listed |
| Aug 30, 2018 | Medtronic Navigation, Inc.-Littleton O-arm 1000 2nd Edition Imaging System, BASE BASE OARM Bl70000027120R SYSTEM 120V RWK, Model Number Bl70000027120R
Product Usage:
The O-arm Imaging System is a mobile x-ray system designed for 2D fluo Terminated |
OXO | None listed |
| Aug 30, 2018 | Medtronic Navigation, Inc.-Littleton O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027230 SYSTEM 230V, Model Number Bl7000002 7230
Product Usage:
The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic a Terminated |
OXO | None listed |
| Aug 30, 2018 | Medtronic Navigation, Inc.-Littleton O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027230R SYSTEM 230V RWK, Model Number Bl70000027230R
Product Usage:
The O-arm Imaging System is a mobile x-ray system designed for 2D fluorosco Terminated |
OXO | None listed |
| Aug 30, 2018 | Medtronic Navigation, Inc.-Littleton O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027GER SYS PRODUCT GER, Model Number Bl70000027GER
Product Usage:
The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopi Terminated |
OXO | None listed |
| Aug 30, 2018 | Medtronic Navigation, Inc.-Littleton O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027GERR SYS PRODUCT REFURB, Model Number Bl70000027GERR
Product Usage:
The O-arm Imaging System is a mobile x-ray system designed for 2D fluoro Terminated |
OXO | None listed |
| Jan 25, 2018 | Medtronic Navigation, Inc.-Littleton O-arm 1000 mobile image-intensified fluoroscopic x-ray system; (1) Model: BASE OARM Bl70000028100 SYS 100V, Product Number: Bl70000028100 (UDI: 00643169354418); (2) Model: BASE OARM Bl70000028120 SYS Terminated |
OXO | None listed |
| Mar 17, 2016 | Medtronic Navigation, Inc.-Littleton Medtronic 0-arm Imaging mobile x-ray system.
Model Numbers - B1-700-00027,
B1-700-00028 Terminated |
OXO | None listed |
| Feb 28, 2014 | Medtronic Navigation, Inc. Medtronic O-arm Imaging System Mobile X-ray system.
Model No. BI-700-00027 and BI-700-00028
The 0-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intend Terminated |
OXO | None listed |
| Mar 8, 2013 | Medtronic Navigation, Inc. Medtronic O-arm Imaging System
Product Usage:
image-intensified fluoroscopic x-ray system, mobile Terminated |
OXO | None listed |
| Aug 22, 2012 | Medtronic Navigation, Inc. Medtronic O-arm Imaging System. Product Numbers: BI-700-00027-100, BI-700-00027-100R, BI-700-00027-120, BI-700-00027-120R, BI-700-00027-230, BI-700-00027-230R. Terminated |
OXO | None listed |
| Jun 21, 2012 | Medtronic Navigation, Inc. Medtronic 0-arm Imaging System with Software Version 3.1.1, Catalog Numbers: BI-700-00027-120R and BI-700-00027-120. The 0-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and Terminated |
IZL | None listed |
| Nov 23, 2010 | Medtronic Navigation, Inc. Medtronic Navigation O-Arm Imaging System, Door Assembly
(BI-700-00006) used in Product Catalog Numbers:
9732719,9733346,81-700-00027, 81-700-00027R, 81700-
00027-100, 81-700-00027-1 OOR, 81-700-0002 Terminated |
IZL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.