FDA.reportPublic FDA data

EXTRON 7

Primary DI
08800018420904
Brand
EXTRON 7
Company
DRTECH Corporation
Model
EXTRON 7
Published
2023-08-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JAASystem, X-Ray, Fluoroscopic, Image-Intensified
OWBInterventional Fluoroscopic X-Ray System
OXOImage-Intensified Fluoroscopic X-Ray System, Mobile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAASystem, X-Ray, Fluoroscopic, Image-IntensifiedRadiology2
OWBInterventional Fluoroscopic X-Ray SystemRadiology2
OXOImage-Intensified Fluoroscopic X-Ray System, MobileRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230871000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230871000EXTRON 5; EXTRON 7DRTECH Corporation2023-08-17OWB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800018420904PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800018420904088000184209048800018420904

GMDN Terms#

Term, Definition table
TermDefinition
Mobile general-purpose fluoroscopic x-ray system, digitalA mobile (within an imaging facility) general-purpose diagnostic fluoroscopic x-ray system that uses a C-arm and digital techniques for image capture, display and manipulation and is designed to be used in a variety of general-purpose applications requiring real-time fluoroscopic imaging capabilities. 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. Images can be both real-time and delayed formats.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
689842626
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800018408209EXPD 4343SEXPD 4343S2026-03-17
08800018408308EXPD 4343DEXPD 4343D2026-03-17
08800018408407EXPD 3643DEXPD 3643D2026-03-17
08800018412008EConsole2EConsole22026-03-17
08800018424704XERO-alphaXERO α2026-03-17
08800018403808FLAATZFLAATZ 5602016-09-02
08800018422601EXTRON 3EXTRON 32025-06-17
08800018430002EXPD-N seriesEXPD 4343N12025-06-13
08800018430101EXPD-N seriesEXPD 4343N2025-06-13
08800018430200EXPD-N seriesEXPD 4343U12025-06-13
08800018430309EXPD-N seriesEXPD 4343NU2025-06-13
08800018430408EXPD-N seriesEXPD 4343NP2025-06-13
08800018430507EXPD-N seriesEXPD 3643N12025-06-13
08800018430606EXPD-N seriesEXPD 3643N2025-06-13
08800018430705EXPD-N seriesEXPD 3643U12025-06-13
08800018430804EXPD-N seriesEXPD 3643NU2025-06-13
08800018430903EXPD-N seriesEXPD 3643NP2025-06-13
08800018420805EXTRON 5EXTRON 52023-08-24
08800018408506EXPD 114, EXPD 114G, EXPD 114P, EXPD 114PGEXPD 1142025-03-27
08800018408605EXPD 114, EXPD 114G, EXPD 114P, EXPD 114PGEXPD 114G2025-03-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060508110057Cydar MapsCYDAR LIMITEDOWB2026-05-27
08055186671225A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOWB2026-05-21
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
08055186671232A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOWB2026-05-21
08055186671249A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOWB2026-05-21
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 SRLOWB2026-05-21
08055186671256A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOXO2026-05-21
B225100000220Orthoscan TAU MVP 1515Ziehm-Orthoscan, Inc.OXO2026-04-30
B225100000220Orthoscan TAU MVP 1515Ziehm-Orthoscan, Inc.JAA2026-04-30
B225100000230Orthoscan TAU MVP 2020Ziehm-Orthoscan, Inc.JAA2026-04-30
B225100000230Orthoscan TAU MVP 2020Ziehm-Orthoscan, Inc.OXO2026-04-30
08809365283033SG HealthcareSG Healthcare Co., Ltd.OWB2026-04-24
08809244060533GenorayGENORAY CO., LTD.OWB2026-04-10
08809244060533GenorayGENORAY CO., LTD.JAA2026-04-10
08809244060557GenorayGENORAY CO., LTD.JAA2026-04-10
08809244060557GenorayGENORAY CO., LTD.OWB2026-04-10
08809244060632GenorayGENORAY CO., LTD.JAA2026-04-10
08809244060632GenorayGENORAY CO., LTD.OWB2026-04-10
08809244060601GenorayGENORAY CO., LTD.OWB2025-12-01
08809244060618GenorayGENORAY CO., LTD.JAA2025-12-01
08809244060625GenorayGENORAY CO., LTD.JAA2025-12-01
08809244060700GenorayGENORAY CO., LTD.JAA2025-12-01
08809244060700GenorayGENORAY CO., LTD.OXO2025-12-01
04056869993973LUMINOS Q.namix RSiemens Healthcare GmbHJAA2025-07-30
04056869993973LUMINOS Q.namix RSiemens Healthcare GmbHOWB2025-07-30
04056869993980LUMINOS Q.namix TSiemens Healthcare GmbHOWB2025-07-30
04056869993980LUMINOS Q.namix TSiemens Healthcare GmbHJAA2025-07-30
00850073646007TrackXTrackX Technology, LLCOWB2025-07-24