FDA.reportPublic FDA data

Huestis Medical Collimator

Primary DI
00850077007002
Brand
Huestis Medical Collimator
Company
HUESTIS MACHINE CORPORATION
Model
CM-1100
Device description
X-Ray Collimator, Manual
Published
2016-07-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IZXCollimator, Manual, Radiographic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IZXCollimator, Manual, RadiographicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K972966000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K972966000AXT 150M MANUAL COLLIMATOR (AXT 150M)Applied X-Ray Technologies, Inc.1997-08-21IZX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850077007002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850077007002008500770070028500770070020850077007002

GMDN Terms#

Term, Definition table
TermDefinition
Manual-aperture-control diagnostic x-ray system collimator, non-motorizedA standard, non-motorized, diagnostic x-ray beam-limiting device whose aperture size/length/shutter assembly must be manually adjusted in order to match the size of the x-ray beam to the size of the x-ray cassette in use. It includes designs with manual controls that operate one or more shutter pairs and also designs that require the addition or removal of attachments or extensions that allow the operator to alter the size and shape of the exit beam from a cone or cylinder. An x-ray collimator is used to limit the effects of scattered radiation on image quality and to provide patient protection by eliminating exposure to non-target body areas.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
001188390
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850077007293Huestis Medical Flexi-HolderFH303DP-122025-03-05
00850077007286Huestis Medical CollimatorCM-32211-QMI2021-04-02
00850077007279Huestis Medical CollimatorCM-3201-1022021-03-19
00850077007255Huestis Centralite Patient Positioning LaserCTL-DLL-22142021-02-18
00850077007262Huestis Centralite Patient Positioning LaserCTL-DLG-22142021-02-18
00850077007217Huestis Centralite Patient Positioning LaserDLG22021-02-04
00850077007224Huestis Centralite Patient Positioning LaserDLL22021-02-04
00850077007231Huestis Centralite Patient Positioning LaserDLL42021-02-04
00850077007248Huestis Centralite Patient Positioning LaserDLG42021-02-04
00850077007019Huestis Medical CollimatorCM-3201-0082016-07-18
00850077007026Huestis Medical CollimatorCM-32012-0082016-07-18
00850077007033Huestis Medical CollimatorCM-10032016-07-18
00850077007040Huestis Medical Flexi-HolderFH410-GE2016-07-18
00850077007057Huestis Medical CollimatorCM-3300B-0022016-07-18
00850077007064Huestis Medical CollimatorCM-32001-COV2016-07-18
00850077007071Huestis Medical Flexi-HolderFH3032017-06-19
00850077007088Huestis Medical Flexi-HolderFH303-12016-11-01
00850077007095Huestis Medical Flexi-HolderFH4102016-11-01
00850077007101Huestis Medical Flexi-HolderFH410-12016-11-01
00850077007118Husetis Medical Flexi-HolderFH410-GE2016-11-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975501940459iRayiRay Imaging Technology (Haining) LimitedIZX2025-07-02
06975501940411iRayiRay Imaging Technology (Haining) LimitedIZX2024-12-16
06975501940428iRayiRay Imaging Technology (Haining) LimitedIZX2024-12-16
08718755004052Varex ImagingVarex Imaging Nederland B.V.IZX2022-09-23
08718755004069Varex ImagingVarex Imaging Nederland B.V.IZX2022-09-23
08718755003208Varex ImagingVarex Imaging Nederland B.V.IZX2022-04-04
08718755003215Varex ImagingVarex Imaging Nederland B.V.IZX2022-04-04
08718755003222Varex ImagingVarex Imaging Nederland B.V.IZX2022-04-04
08718755003239Varex ImagingVarex Imaging Nederland B.V.IZX2022-04-04
08718755003246Varex ImagingVarex Imaging Nederland B.V.IZX2022-04-04
08718755003253Varex ImagingVarex Imaging Nederland B.V.IZX2022-04-04
08718755003260Varex ImagingVarex Imaging Nederland B.V.IZX2022-04-04
08718755003277Varex ImagingVarex Imaging Nederland B.V.IZX2022-04-04
08718755003284Varex ImagingVarex Imaging Nederland B.V.IZX2022-04-04
08718755003291Varex ImagingVarex Imaging Nederland B.V.IZX2022-04-04
08718755003307Varex ImagingVarex Imaging Nederland B.V.IZX2022-04-04
08718755003314Varex ImagingVarex Imaging Nederland B.V.IZX2022-04-04
08718755003321Varex ImagingVarex Imaging Nederland B.V.IZX2022-04-04
08718755003338Varex ImagingVarex Imaging Nederland B.V.IZX2022-04-04
08718755003345Varex ImagingVarex Imaging Nederland B.V.IZX2022-04-04
08718755003352Varex ImagingVarex Imaging Nederland B.V.IZX2022-04-04
08718755003369Varex ImagingVarex Imaging Nederland B.V.IZX2022-04-04
08718755003376Varex ImagingVarex Imaging Nederland B.V.IZX2022-04-04
08718755003383Varex ImagingVarex Imaging Nederland B.V.IZX2022-04-04
08718755003390Varex ImagingVarex Imaging Nederland B.V.IZX2022-04-04
08718755003406Varex ImagingVarex Imaging Nederland B.V.IZX2022-04-04
08718755003413Varex ImagingVarex Imaging Nederland B.V.IZX2022-04-04
08718755003420Varex ImagingVarex Imaging Nederland B.V.IZX2022-04-04
08718755003437Varex ImagingVarex Imaging Nederland B.V.IZX2022-04-04
08718755001969Varex ImagingVarex Imaging Nederland B.V.IZX2022-02-07