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
00199150071968Stealth AXiS Leica Kit97367562026-09-25
00199150071975Stealth AXiS Kinevo 900 Kit97367572026-09-25
00199150071982Stealth AXiS Pentero 900 Kit97367582026-09-25
00199150054404ZEISS TIVATO 70097367222026-09-21
00199150054442ZEISS PENTERO 800S97367242026-09-21
00199150067633Stealth AXiS Advanced Spine Referencing Kit97366922026-09-06
00763000994501Stealth AXiS Spine Referencing Kit SS97366962026-09-06
00763000994525Stealth AXiS Advanced Spine Referencing Kit SS97366972026-09-06
00763000994549Stealth AXiS EM Emitter Arm Bed Kit SS97366982026-09-06
00763000994563Stealth AXiS EM Spine Retractors Kit SS97366992026-09-06
00763000384234N/A97361462021-08-13
00199150071593Stealth AXiS™ 3D-to-Fluoro Round Adapter Kit97367642026-08-22
00199150071616Stealth AXiS™ 3D-to-Fluoro Flat Adapter Kit97367662026-08-22
00763000989972Stealth AXiS™ 3D-to-Fluoro Flat C-arm Tracker97365192026-08-22
00763000989989Stealth AXiS™ 3D-to-Fluoro Round C-arm Tracker97365332026-08-22
00763000994587Stealth AXiS™ GEHC CRANIAL INTEGRATION KIT Stainless Steel97367002026-08-17
00199150067664Stealth AXiS™ GEHC CRANIAL INTEGRATION KIT97366952026-08-15
00763000989958Stealth AXiS™ GEHC Craniotomy Transducer Tracker97365172026-08-15
00763000989965Stealth AXiS™ GEHC craniotomy Transducer Verification Device97365182026-08-15
00763000995195Stealth AXiS97366722026-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850079606081MC2 Portable X-ray SystemOXOS Medical, Inc.OXO2026-09-21
00850079606098EmitterOXOS Medical, Inc.OXO2026-09-21
00850079606104CassetteOXOS Medical, Inc.OXO2026-09-21
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