FDA.reportPublic FDA data

Del Medical, Inc.

Primary DI
00858340006479
Brand
Del Medical, Inc.
Company
Del Medical, Inc.
Model
KA Reveal Mobi Pro
Device description
This a motorized mobile diagnostic x-ray system. The Mobile Direct Radiographic system facilitates x-ray examinations, in situations where it is not feasible to transport the patient to a ward with fixed equipment. The unit is precise, yet easy to maneuver due to smooth battery-powered motorization
Published
2026-03-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
IZLSystem, X-Ray, Mobile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IZLSystem, X-Ray, MobileRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858340006479PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858340006479008583400064798583400064790858340006479

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
847-288-7029gbell@delmedical.com

Regulatory Flags#

DUNS number
078671236
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858340006202Del Medical, Inc.DM-SARM2022-04-15
00858340006523Del Medical, Inc.CM-OTC18T2026-03-05
00858340006530Del Medical, Inc.DMX2026-03-05
00858340006547Del Medical, Inc.VT300 (5187)2026-03-05
00858340006486Del Medical, Inc.CM-OTC18M2024-05-09
00858340006400Del Medical, Inc.FM-OTC18T2024-03-18
00858340006417Del Medical, Inc.FM-OTC18M2024-03-18
00858340006424Del Medical, Inc.FM-FMT18T2024-03-18
00858340006431Del Medical, Inc.FM-FMT18M2024-03-18
00858340006448Del Medical, Inc.MT500-F2024-03-18
00858340006455Del Medical, Inc.MT500-EL2024-03-18
00858340006462Del Medical, Inc.MT500-EB2024-03-18
00858340006387Del Medical, Inc.VS502023-05-16
00858340006073Del Medical, Inc.DM-FWFC2022-04-15
00858340006110Del Medical, Inc.OTC18S2022-04-15
00858340006134Del Medical, Inc.EV800T2022-04-15
00858340006141Del Medical, Inc.VT300T2022-04-15
00858340006158Del Medical, Inc.DM-OTC18S2022-04-15
00858340006165Del Medical, Inc.DM-OTC18T2022-04-15
00858340006172Del Medical, Inc.DM-OTC18M2022-04-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800011150129DRGEMDRGEM CorporationIZL2026-05-20
08800011150136DRGEMDRGEM CorporationIZL2026-05-20
07350011170005TrueMobileSolutions For Tomorrow ABIZL2026-05-18
08800184900002X-RAYNEUF Inc.IZL2026-05-11
08800184900019X-RAYNEUF Inc.IZL2026-05-11
08908021109097PRORAD ATLAS ULTRAPORTABLEPROGNOSYS MEDICAL SYSTEMS PRIVATE LIMITEDIZL2026-05-07
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
00850079606043MC2 Portable X-ray SystemOXOS Medical, Inc.IZL2026-03-25
00850079606050EmitterOXOS Medical, Inc.IZL2026-03-25
04547410571134FDR AQROFUJIFILM CORPORATIONIZL2026-03-20
08800060100229REMEX Xcam6REMEDI CO.,LTD.IZL2026-01-22
04056869297309MOBILETT ImpactSiemens Healthcare GmbHIZL2025-11-20
08800011150105DRGEMDRGEM CorporationIZL2025-08-26
08800011150112DRGEMDRGEM CorporationIZL2025-08-26
08800070400074HnX-P1H&abyz Co., LtdIZL2025-08-12
08800070400166HnX-PBH&abyz Co., LtdIZL2025-08-12
08436046003651SEDECALSEDECALIZL2025-03-21
08436046003668SEDECALSEDECALIZL2025-03-21
08436046003675SEDECALSEDECALIZL2025-03-21
08436046003682SEDECALSEDECALIZL2025-03-21
08436046003699SEDECALSEDECALIZL2025-03-21
08436046003705SEDECALSEDECALIZL2025-03-21
08436046003712SEDECALSEDECALIZL2025-03-21
08436046003729SEDECALSEDECALIZL2025-03-21