FDA.reportPublic FDA data

Standard Imaging IMSure 3D

Primary DI
00850019946543
Brand
Standard Imaging IMSure 3D
Company
STANDARD IMAGING INC.
Model
91365
Catalog number
91365
Device description
Standard Imaging IMSure 3D (IM3D) QA software is intended to be used for radiation dose calculation and radiation treatment plan quality assurance in radiation therapy.
Published
2023-11-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
IYEAccelerator, Linear, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850019946543PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850019946543008500199465438500199465430850019946543

GMDN Terms#

Term, Definition table
TermDefinition
Radiation therapy softwareAn application software program intended to facilitate/support the delivery of therapeutic radiation by enabling computer-assisted functionality in one or more of the following areas: treatment planning, simulation, record/verify, beam block CAD/CAM, quality assurance, and patient positioning. Some types may be combined with specific hardware or firmware accessories or configurations in order to function as intended.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
788084705
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850019946031Standard Imaging Seed Slider90090900902023-06-22
00850019946048Standard Imaging Needle Loading Shield90070900702023-06-22
00850019946062Standard Imaging Needle Cradle 90095900952023-06-22
00850019946079Standard Imaging CDX 2000B Electrometer90001900012023-06-22
00850019946086Standard Imaging MAX 4000 Plus Electrometer90020900202023-06-22
00850019946093Standard Imaging SuperMAX Electrometer90018900182023-06-22
00850019946109Standard Imaging MAX SD90030900302023-06-22
00850019946116Standard Imaging QA BeamChecker Plus90501905012023-06-22
00850019946123Standard Imaging QA StereoChecker91349913492023-06-22
00850019946130Standard Imaging Exradin Magna 60092600926002023-06-22
00850019946147Standard Imaging Exradin Magna 650 Ion Chamber92650926502023-06-22
00850019946154Standard Imaging Exradin A17 Ion Chamber92675926752023-06-22
00850019946161Standard Imaging Exradin A101 Ion Chamber92680926802023-06-22
00850019946178Standard Imaging Exradin A12 Ion Chamber92700927002023-06-22
00850019946185Standard Imaging Exradin A11 Ion Chamber92701927012023-06-22
00850019946192Standard Imaging Exradin A1 Ion Chamber92705927052023-06-22
00850019946208Standard Imaging Exradin A11TW Ion Chamber92708927082023-06-22
00850019946215Standard Imaging Exradin A14 Ion Chamber92711927112023-06-22
00850019946222Standard Imaging TomoElectrometer90016900162023-06-22
00850019946239Standard Imaging Exradin A4 Ion Chamber92715927152023-06-22

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07340145700421Gold AnchorNaslund Medical ABIYE2023-01-23
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07340145701169Gold AnchorNaslund Medical ABIYE2023-01-23
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