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Standard Imaging PIPSpro Software

Primary DI
00866562000236
Brand
Standard Imaging PIPSpro Software
Company
STANDARD IMAGING INC.
Model
v5
Catalog number
91309
Device description
Standard Imaging PIPSpro Software is a stand alone software medical device used for QA checks of imaging systems used with radiation therapy systems.
Published
2016-10-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
IXGPhantom, Anthropomorphic, Radiographic
IYEAccelerator, Linear, Medical
LHOInstrument, Quality-Assurance, Radiologic
LLZSystem, Image Processing, Radiological
LMBDevice, Digital Image Storage, Radiological
LMDSystem, Digital Image Communications, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IXGPhantom, Anthropomorphic, RadiographicRadiology1
IYEAccelerator, Linear, MedicalRadiology2
LHOInstrument, Quality-Assurance, RadiologicRadiology1
LLZSystem, Image Processing, RadiologicalRadiology2
LMBDevice, Digital Image Storage, RadiologicalRadiology1
LMDSystem, Digital Image Communications, RadiologicalRadiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K042733000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042733000STANDARD IMAGING PIPSPRO QA SOFTWARE SYSTEMStandard Imaging, Inc.2004-11-15LHO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00866562000236PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00866562000236008665620002368665620002360866562000236

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850019946543Standard Imaging IMSure 3D91365913652023-11-29
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

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