FDA.reportPublic FDA data

DRGEM

Primary DI
08800011150136
Brand
DRGEM
Company
DRGEM Corporation
Model
RAYMO
Device description
Power Specification :100-240V~ / 150kV
Published
2026-05-20
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
IZLSystem, X-Ray, Mobile
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IZLSystem, X-Ray, MobileRadiology2
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)Radiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K260085000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K260085000RAYMO Mobile X-ray System (Model: RAYMO)DRGEM Corporation2026-05-14IZL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800011150136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800011150136088000111501368800011150136

GMDN Terms#

Term, Definition table
TermDefinition
Mobile basic diagnostic x-ray system, digitalAn assembly of devices that comprise a digital general-purpose mobile diagnostic x-ray system used in a variety of routine planar x-ray imaging applications. It uses digital techniques for image capture, display and manipulation and the mobile design allows it to operate on mains or battery power and to be driven or pushed by an operator to various locations within a building or facility. It is commonly used for bedside imaging and for interventional and intraoperative imaging. It consists of basic modular configurations that can be upgraded. This GMDN code does not cover systems with fluoroscopic or tomographic capabilities.

Regulatory Flags#

DUNS number
688477319
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800011150129DRGEMRAYMO2026-05-20
08800011140076DRGEMGXR-52SD2019-10-07
08800011140090DRGEMGXR-82SD2019-10-07
08800011140106DRGEMGXR-C32SD2019-10-07
08800011140113DRGEMGXR-C40SD2019-10-07
08800011140120DRGEMGXR-C52SD2019-10-07
08800011140137DRGEMGXR-U32SD2019-10-07
08800011140144DRGEMGXR-U40SD2019-10-07
08800011140182DRGEMGXR-32SD2019-10-07
08800011140199DRGEMGXR-32SD2019-10-07
08800011140205DRGEMGXR-32SD2019-10-07
08800011140212DRGEMGXR-32SD2019-10-07
08800011140229DRGEMGXR-40SD2019-10-07
08800011140236DRGEMGXR-40SD2019-10-07
08800011140243DRGEMGXR-40SD2019-10-07
08800011140250DRGEMGXR-40SD2019-10-07
08800011140267DRGEMGXR-52SD2019-10-07
08800011140274DRGEMGXR-68SD2019-10-07
08800011140281DRGEMGXR-82SD2019-10-07
08800011140298DRGEMGXR-C32SD2019-10-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800011150129DRGEMDRGEM CorporationMQB2026-05-20
08800011150129DRGEMDRGEM CorporationIZL2026-05-20
08809413811096ExamVue ApexJPI HEALTHCARE. CO., LTD.MQB2026-05-14
08809413811126ExamVue ApexJPI HEALTHCARE. CO., LTD.MQB2026-05-14
08809413811133ExamVue ApexJPI HEALTHCARE. CO., LTD.MQB2026-05-14
08800184900002X-RAYNEUF Inc.IZL2026-05-11
08800184900019X-RAYNEUF Inc.IZL2026-05-11
08908021109097PRORAD ATLAS ULTRAPORTABLEPROGNOSYS MEDICAL SYSTEMS PRIVATE LIMITEDIZL2026-05-07
B225100000220Orthoscan TAU MVP 1515Ziehm-Orthoscan, Inc.MQB2026-04-30
B225100000230Orthoscan TAU MVP 2020Ziehm-Orthoscan, Inc.MQB2026-04-30
08809365280001SG HealthcareSG Healthcare Co., Ltd.MQB2026-04-24
08809365281015SG HealthcareSG Healthcare Co., Ltd.MQB2026-04-24
08908021109103PRORAD ATLAS ULTRAPORTABLE PLUSPROGNOSYS MEDICAL SYSTEMS PRIVATE LIMITEDIZL2026-04-16
08800040900108Diagnostic X-ray UnitPoskom Co., Ltd.IZL2026-04-15
08800040900221Airbile-100Poskom Co., Ltd.IZL2026-04-15
08800040900245AirRay-miniPoskom Co., Ltd.IZL2026-04-15
08800040900252AirRay-miniPoskom Co., Ltd.IZL2026-04-15
08800040900269AirRay-miniPoskom Co., Ltd.IZL2026-04-15
08800040900276AirRay-miniPoskom Co., Ltd.IZL2026-04-15
08055186671089A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLMQB2026-04-02
00198953056103DefiniumGE Hualun Medical Systems Co., LtdMQB2026-02-12
00198953056158DefiniumGE Hualun Medical Systems Co., LtdMQB2026-02-12
00195278913814DefiniumGE Hualun Medical Systems Co., LtdMQB2025-09-05
08800011150112DRGEMDRGEM CorporationMQB2025-08-26
B225100000200Orthoscan Versa Mini C-ArmZiehm-Orthoscan, Inc.MQB2025-07-11
08436046003651SEDECALSEDECALIZL2025-03-21
08436046003668SEDECALSEDECALIZL2025-03-21
08436046003675SEDECALSEDECALIZL2025-03-21
08436046003682SEDECALSEDECALIZL2025-03-21
08436046003699SEDECALSEDECALIZL2025-03-21