Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004785967

FEI Number

3004785967

Entity Name

MEDTRONIC NAVIGATION, INC. (Boxborough)

City/State/Country

Boxborough, MA, US

Establishment Address

200 Beaver Brook Rd, Boxborough, MA 01719, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Medtronic, Inc. (Owner Number: 2112641)

Owner / Operator Contact Address

710 Medtronic Parkway, Minneapolis, MN 55432, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K240465

PMA Number

N/A

All Registered Proprietary Names

O-arm Equipment Drape Surgical drape and drape accessories O-Arm O2 Imaging System O-arm O2 imaging system

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2017-12-05
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2010-12-01
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2020-10-15
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2020-10-15
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2020-10-15
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2015-08-17
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2015-08-17
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2015-08-17
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2024-08-16
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2024-08-16
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2024-08-16

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Medtronic, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007042319	HeartWare, Inc.	Miami Lakes, FL, US
3004497303	MEDTRONIC MEXICO EG	EMPALME Sonora, MX
3015192387	CATHWORKS	Newport Beach, CA, US
3004185781	Medtronic, Inc.	Tempe, AZ, US
3012520654	MEDTRONIC, INC.	Billerica, MA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K103464	Medtronic, Inc.	PACIFIC XTREME PTCA BALLOON DILATATION CATHETER	2010-12-22
K111339	Medtronic, Inc.	HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS)	2011-06-08
K060344	Breakaway Imaging, LLC	O-ARM IMAGING SYSTEM	2006-03-29
K982706	Philips Medical Systems, Inc.	PHILIPS BV300 SERIES RELEASE 2.1	1998-09-02
K863853	Superior Medical Products	EAZY COVERS	1987-03-06

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2007	GE OEC Medical Systems, Inc	2	GE 4 inch Anterior Cervical Post, GE Part Number 1006385 or 1006385-NAV, GE Healthcare OEC Medical Systems (an accessory used with the InstaTrak 3500 plus and 9800 C-Arm Navigation systems)
Z-0001-2009	Philips Medical Systems North America Co. Phillips	2	NeuViz Dual Multi-Slice Computed Tomography (CT) Scanner System (software). Whole body x-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system software is an interactive program used for x-ray scan control, image reconstruction, and image archive/evaluation. It is intended to produce cross-section images of head and body by computer reconstruction of x-ray transmission data taken at different angles. The function of Time Scan is intended to use in contrast scan include single phase and multi-phase scan, that is according to different density of contrast in vessels or organs between different phase to get necessary information to support doctor's diagnosis.
Z-0004-2010	Ge Healthcare	2	GE OEC 9900 Elite ESP To produce mobile fluoroscopic images of human anatomy.
Z-0005-2010	Ge Healthcare	2	GE OEC 9900 Elite GSP Fluoroscopes To produce mobile fluoroscopic images of human anatomy.
Z-0009-04	Siemens Medical Solutions USA, Inc	2	Urology X-Ray System, Uroskop D1/D2/D3 - Hardware for Motor Drive

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004785967. Last updated year: 2026. Please use registration number 3004785967 when referencing this establishment in official correspondence.