FDA.reportPublic FDA data

O-ARM®

Primary DI
20643169803002
Brand
O-ARM®
Company
MEDTRONIC NAVIGATION, INC.
Model
9732721
Device description
MOUSE 9732721 STERILE O-ARM 10
Published
2017-08-12
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
20643169803002PrimaryGS10
00643169803008Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2064316980300220643169803002
00643169803008006431698030086431698030080643169803008

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
00763000404871StealthStation™97359632026-05-23
00199150006427Stealth AXiS97365512026-04-24
00199150071586Stealth AXiS97367642026-04-19
00199150071609Stealth AXiS97367662026-04-19
00763000928896Stealth AXiS97365172026-04-11
00763000928902Stealth AXiS97365182026-04-11
00763000928919Stealth AXiS97365212026-04-10
00763000928926Stealth AXiS97365332026-04-10
00763000945947Stealth AXiS97365202026-04-10
00763000945954Stealth AXiS97365192026-04-10
00763000983840Stealth AXiS97366782026-04-11
00763000983864Stealth AXiS97366792026-04-11
00763000983888Stealth AXiS97366802026-04-11
00763000984441Stealth AXiS97364812026-04-10
00763000984458Stealth AXiS97364822026-04-10
00763000984465Stealth AXiS97364832026-04-10
00763000984472Stealth AXiS97364842026-04-10
00763000984489Stealth AXiS97364852026-04-10
00763000984496Stealth AXiS97364862026-04-10
00763000984502Stealth AXiS97365032026-04-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00884838112292Zenition 90Philips Medical Systems Nederland B.V.OXO2024-05-28