EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG

Primary DI
08800018407301
Brand
EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG
Company
DRTECH Corporation
Model
EXPD 129P
Device description
The EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG Digital X-ray detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. This device is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. This device is not intended for mammography applications. It is intended for both adult and pediatric populations.
Published
2022-11-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)Radiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223124000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223124000EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PGDRTECH Corporation2022-11-18MQB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800018407301PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800018407301088000184073018800018407301

GMDN Terms#

Term, Definition table
TermDefinition
Indirect flat panel x-ray detectorAn electrically-powered, cassette-like device intended to be used as part of an x-ray system to detect x-ray images following exposure, and create a digital signal; it is not dedicated to imaging of a specific anatomy. It includes two types of transducing technology (i.e., indirect): a scintillator [e.g. caesium iodide (CsI)] screen converts x-ray energy into light, followed by the conversion of light into a digital signal by photodiode array. The image data can be sent to an appropriate processing unit through a wired or wireless connection (e.g., Wi-Fi). It may be used in place of a fixed detector in x-ray imaging systems, e.g., as part of a digital imaging conversion system.

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
08800018420904EXTRON 7EXTRON 72023-08-24
08800018408506EXPD 114, EXPD 114G, EXPD 114P, EXPD 114PGEXPD 1142025-03-27

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