FDA.reportPublic FDA data

Huestis Medical Collimator

Primary DI
00850077007286
Brand
Huestis Medical Collimator
Company
HUESTIS MACHINE CORPORATION
Model
CM-32211-QMI
Device description
150PBL Collimator (Huestis Part # CM-32211-QMI)
Published
2021-04-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
00850077007286PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850077007286008500770072868500770072860850077007286

GMDN Terms#

Term, Definition table
TermDefinition
Automatic-aperture-control diagnostic x-ray system collimatorA standard, diagnostic x-ray beam-limiting and shaping device that includes an automatically controlled motorized shutter mechanism. It is designed to adjust the shutters so that the x-ray beam shape matches the size of the film cassette in the holder and is attached to the beam exit port of a diagnostic x-ray system tube housing assembly. It typically includes a light-centring device that is used to project a light field onto the patient that is coincident with the x-ray beam in order to centre the tube over the film cassette. It 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

Contacts#

Phone, Email table
PhoneEmail
1-401-253-5500sales@huestis.com

Regulatory Flags#

DUNS number
001188390
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850077007293Huestis Medical Flexi-HolderFH303DP-122025-03-05
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
00850077007002Huestis Medical CollimatorCM-11002016-07-01
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