FDA.reportPublic FDA data

O-ARM®

Primary DI
20885074546180
Brand
O-ARM®
Company
MEDTRONIC NAVIGATION, INC.
Model
9732721
Device description
MOUSE 9732721 STERILE O-ARM 10PK
Published
2016-09-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OXOImage-intensified fluoroscopic x-ray system, mobile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OXOImage-Intensified Fluoroscopic X-Ray System, MobileRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K060344000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060344000O-ARM IMAGING SYSTEMBreakaway Imaging, LLC2006-03-29OXO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20885074546180PrimaryGS10
00885074546186Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088507454618020885074546180
00885074546186008850745461868850745461860885074546186

GMDN Terms#

Term, Definition table
TermDefinition
Portable general-purpose fluoroscopic x-ray system, digitalA portable (moveable from one location to another, and easily reassembled) general-purpose diagnostic fluoroscopic x-ray system that uses real-time digital techniques for image capture, display and manipulation and is specifically designed to be used in a variety of general-purpose applications requiring real-time fluoroscopic imaging. It includes spot-film capabilities in addition to the fluoroscopic features and is intended to optimize the capability of users to visually and quantitatively evaluate the anatomy and physiological function of various targeted body areas in real-time. It is frequently used in conjunction with an ingested or injected x-ray contrast medium.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
803580559
Device count
10
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150054398StealthStation S897357622026-08-07
00199150054466N/A97367262026-08-08
00199150057078AXIS AP ROBOTIC TOOL CHANGER 973668197366812026-08-09
00199150067626KIT 9736691 SPINE REFERENCING97366912026-08-07
00199150074396CLAMP 9736433 SPINE STRAIGHT TALL97364332026-08-07
00199150074402CLAMP 9736465 SPINE STRAIGHT MEDIUM97364652026-08-07
00199150074419CLAMP 9736434 SPINE STRAIGHT SHORT97364342026-08-07
00199150074426CLAMP 9736467 SPINE DOUBLE MEDIUM97364672026-08-07
00763000381141N/A97314602026-08-08
00763000989927AXIS HYBRID REF FRAME 973651197365112026-08-07
00763000989941AXIS EM SEGMENT TRACKER DRIVER 973651397365132026-08-07
00763000539238SteathStation97364262023-08-04
00763000539108SteathStation97364232022-02-07
00763000539177SteathStation97364262022-02-07
00763000914097Stealth AXiS97365032026-07-24
00763000914035Stealth AXiS97364812026-07-17
00763000914042Stealth AXiS97364822026-07-17
00763000914059Stealth AXiS97364832026-07-17
00763000914066Stealth AXiS97364842026-07-17
00763000914073Stealth AXiS97364852026-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860014944611nView s1 with nav optionNVIEW MEDICAL INC.OXO2026-07-08
08055186671225A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOXO2026-05-21
08055186671232A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOXO2026-05-21
08055186671249A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOXO2026-05-21
08055186671256A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOXO2026-05-21
B225100000220Orthoscan TAU MVP 1515Ziehm-Orthoscan, Inc.OXO2026-04-30
B225100000230Orthoscan TAU MVP 2020Ziehm-Orthoscan, Inc.OXO2026-04-30
00850079606043MC2 Portable X-ray SystemOXOS Medical, Inc.OXO2026-03-25
00850079606050EmitterOXOS Medical, Inc.OXO2026-03-25
00198953052488AlliaGE MEDICAL SYSTEMSOXO2025-12-17
08809244060700GenorayGENORAY CO., LTD.OXO2025-12-01
00613994462428O-ArmMEDTRONIC NAVIGATION, INC.OXO2025-11-27
B225100000200Orthoscan Versa Mini C-ArmZiehm-Orthoscan, Inc.OXO2025-07-11
08055186671096FUJIFILM Healthcare Americas CorporationA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOXO2025-07-02
08800018422601EXTRON 3DRTECH CorporationOXO2025-06-17
08809244060090GenorayGENORAY CO., LTD.OXO2025-05-02
00195278685001OECGE Hualun Medical Systems Co., LtdOXO2025-01-09
00860001123418CassetteOXOS Medical, Inc.OXO2025-01-01
00860001123425EmitterOXOS Medical, Inc.OXO2025-01-01
00860008892706Foot PedalOXOS Medical, Inc.OXO2025-01-01
00860008892713Wired ChargerOXOS Medical, Inc.OXO2025-01-01
00860008892737CartOXOS Medical, Inc.OXO2025-01-01
00860008892744MC2 AppOXOS Medical, Inc.OXO2025-01-01
00860008892782MC2 Portable X-ray SystemOXOS Medical, Inc.OXO2025-01-01
08053307591070TRIDENTTECHNIX SPAOXO2024-11-06
08053307591087TRIDENTTECHNIX SPAOXO2024-11-06
00643169618121O-armMEDTRONIC NAVIGATION, INC.OXO2024-10-10
00763000709631O-armTM O2 Imaging SystemMEDTRONIC NAVIGATION, INC.OXO2024-08-26
00193982184506EXCELSIUS3DGLOBUS MEDICAL, INC.OXO2024-06-26
00193982184537EXCELSIUS3DGLOBUS MEDICAL, INC.OXO2024-06-26