FDA.reportPublic FDA data

Summit X-ray Collimator

Primary DI
B307D8000
Brand
Summit X-ray Collimator
Company
SUMMIT INDUSTRIES, LLC
Model
D800
Catalog number
D800
Device description
Collimator, manual, Radiographic (892-1610)
Published
2016-09-15
Public version status
Update
Distribution status
Not 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
K874687000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K874687000COLLI-MATETM MODEL NO. B800Summit Industries, Inc.1987-12-30IZX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B307D8000PrimaryHIBCC0

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure10 Degrees Celsius40 Degrees Celsius
Special Storage Condition, Specify00Keep dry

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1773-353-4000villih@summitindustries.Net
+17733534000davidv@summitindustries.net

Regulatory Flags#

DUNS number
130235187
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B307J7000SummitJ700J7002016-11-07
B307S1050SummitS105S1052016-11-07
B307S1130SummitS113S1132016-11-07
B307S1140SummitS114S1142016-11-07
B307S2030SummitS203S2032016-11-07
B307S2250SummitS225S2252016-11-07
B307A172F0SummitA-172FA-172F2017-04-01
B307C2560Summit Radiographic tableC256C2562016-09-15
B307J10000SummitJ1000J10002016-11-01
B307S1020SummitS102S1022016-11-01
B307S1070SummitS107S1072016-11-01
B307S1080SummitS108S1082016-11-01
B307S1090SummitS109S1092016-11-01
B307S1110SummitS111S1112016-11-01
B307S2000Summit Radiographic tableS200S2002016-09-15
B307S2040Summit Radiographic tableS204S2042016-09-15
B307S2100Summit Radiographic tableS210S2102016-09-15
B307S2110Summit Radiographic tableS211S2112016-09-15
B307S2120Summit Radiographic tableS212S2122016-09-15
B307S2220Summit Radiographic tableS222S2222016-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06975501940428iRayiRay Imaging Technology (Haining) LimitedIZX2024-12-16
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08718755004069Varex ImagingVarex Imaging Nederland B.V.IZX2022-09-23
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08718755001969Varex ImagingVarex Imaging Nederland B.V.IZX2022-02-07