FDA.reportPublic FDA data

CombiMax

Primary DI
B884S06211100L0
Brand
CombiMax
Company
Pausch, L.L.C.
Model
Left Hand
Catalog number
S 0621 1100LH
Published
2022-12-28
Public version status
New
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
B884S06211100L0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Diagnostic X-ray system positioning frameAn electrically-powered component of a diagnostic x-ray system intended to be placed on the floor to position and support a patient, an x-ray tube assembly, and an image receptor assembly (bucky) during a diagnostic x-ray procedure. It typically consists of a patient table, floor stands for the x-ray tube and image receptor, and controls. The table and floor stands may be moved and/or tilted; the image receptor may be included, however the x-ray tube is not included.

Regulatory Flags#

DUNS number
080365572
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
S062110000ElevatorMaxBaseS 0621 10002024-04-24
B884SVMS4000VMS 400BaseSVMS4002024-02-16
B884S10000110R0Paxis 100 AutoRHS10000110R2023-05-12
S10000110R0Paxis 100 AutoRHS10000110L2023-05-03
B884S10000110L0Paxis 100 AutoLHS10000110L2023-05-03
B884SMPRTHD0PATIENT TABLE RegularS MPRTHD2023-01-27
B884S06211100R0CombiMaxRight HandS 0621 1100RH2022-12-28
B884SFS100L0FS 100 WallstandLeft HandS FS 100 LH2022-12-28
B884SFS100R0FS 100 WallstandRight HandS FS 100 RH2022-12-28
B884S04201000L0CirrusLS 0420 1000L2022-12-23
B884S04201000R0CirrusRS 0420 1000R2022-12-23
B884S100002000Paxis 200BaseS100002002022-12-23
B884SMPRT0PATIENT TABLERegularS MPRT2022-12-23
SMPRT0PATIENT TABLERegularS MPRT2022-12-07
B884S10000100L0Paxis 100LHS10000100L2022-12-06
B884S10000100R0Paxis 100RHS10000100R2022-12-06

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
B884S06211100R0CombiMaxPausch, L.L.C.IZZ2022-12-28
00195278527455NAGE Hualun Medical Systems Co., LtdIZZ2022-07-21
00858340006134Del Medical, Inc.Del Medical, Inc.IZZ2022-04-15
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