FDA.reportPublic FDA data

Del Medical, Inc.

Primary DI
00858340006134
Brand
Del Medical, Inc.
Company
Del Medical, Inc.
Model
EV800T
Device description
The EV800T elevating table is designed for general purpose radiography and features a four-way floating table top with longitudinal and transverse travel. The EV800T is intended to be used with the DM-OTC18S auto-stitching system.
Published
2022-04-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IZZTable, Radiographic, Non-Tilting, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IZZTable, Radiographic, Non-Tilting, PoweredRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858340006134PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858340006134008583400061348583400061340858340006134

GMDN Terms#

Term, Definition table
TermDefinition
Basic diagnostic x-ray system table, poweredA powered/programmable table that is a component of a basic diagnostic x-ray system designed to position and support a patient during a variety of routine/planar or speciality diagnostic procedures requiring the use of a diagnostic x-ray system; it is not a planar tomography nor computed tomography (CT) table. It can be a stationary or mobile unit and is made of radiolucent materials with low x-ray attenuation coefficients. It is not intended for use during interventional radiology/surgery.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078671236
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858340006202Del Medical, Inc.DM-SARM2022-04-15
00858340006479Del Medical, Inc.KA Reveal Mobi Pro2026-03-05
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
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
08800011101145DRGEMDRGEM CorporationIZZ2025-02-11
05999116100023PHOENIX 1CONTROL-X Medical Kereskedelmi és Szolgáltató Zártkörűen Működő RészvénytársaságIZZ2024-10-30
S062110000ElevatorMaxPausch, L.L.C.IZZ2024-04-24
05999116100054PHOENIX 2CONTROL-X Medical Kereskedelmi és Szolgáltató Zártkörűen Működő RészvénytársaságIZZ2023-08-15
B884S06211100L0CombiMaxPausch, L.L.C.IZZ2022-12-28
B884S06211100R0CombiMaxPausch, L.L.C.IZZ2022-12-28
00195278527455NAGE Hualun Medical Systems Co., LtdIZZ2022-07-21
00195278012258NAGE Hualun Medical Systems Co., LtdIZZ2020-11-24
00840682140942NAGE Hangwei Medical Systems Company Ltd.IZZ2018-11-09
00840682141895NAGE Hangwei Medical Systems Company Ltd.IZZ2018-11-09
00840682141932NAGE Hualun Medical Systems Co., LtdIZZ2018-11-06
60889978606801DRX - Ascend SystemCARESTREAM HEALTH, INC.IZZ2018-01-15
00850977007058IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.IZZ2017-09-18
00850977007065IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.IZZ2017-09-18
00850977007072IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.IZZ2017-09-18
00850977007089IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.IZZ2017-09-18
00850977007096IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.IZZ2017-09-18
00850977007188IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.IZZ2017-09-18
00850977007195IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.IZZ2017-09-18
00850977007201IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.IZZ2017-09-18
00850977007218IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.IZZ2017-09-18
00850977007225IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.IZZ2017-09-18
00840682102674NAGE Hangwei Medical Systems Company Ltd.IZZ2017-07-28
00840682103572NAGE Healthcare Japan CorporationIZZ2017-07-17
08800011101008DRGEMDRGEM CorporationIZZ2017-05-29
08800011101015DRGEMDRGEM CorporationIZZ2017-05-29
08800011101022DRGEMDRGEM CorporationIZZ2017-05-29
08800011100018DRGEMDRGEM CorporationIZZ2017-05-29
00850977007171IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.IZZ2017-05-18
00850977007041IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.IZZ2017-02-02