FDA.reportPublic FDA data

Standard Imaging IVB 1000 Well Chamber

Primary DI
00866562000250
Brand
Standard Imaging IVB 1000 Well Chamber
Company
STANDARD IMAGING INC.
Model
90009
Catalog number
90009
Device description
Standard Imaging IVB 1000 is a medical device intended as a transducer for brachytherapy radiation QA measurements.
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
IWJSystem, Applicator, Radionuclide, Manual
JAQSystem, Applicator, Radionuclide, Remote-Controlled
KPTCalibrator, Dose, Radionuclide

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IWJSystem, Applicator, Radionuclide, ManualRadiology1
JAQSystem, Applicator, Radionuclide, Remote-ControlledRadiology2
KPTCalibrator, Dose, RadionuclideRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K001825000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K001825000STANDARD IMAGING HDR 1000 PLUS ION CHAMBER; STANDARD IMAGING IVB 1000 ION CHAMBERStandard Imaging, Inc.2000-08-02JAQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00866562000250PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00866562000250008665620002508665620002500866562000250

GMDN Terms#

Term, Definition table
TermDefinition
Radiation condenser R-meterA precise radiation counting instrument that uses a number of interchangeable radiation detection ionization probes and charger-reader mechanism. The charger is used to apply an electrostatic charge to the chamber. The drop in chamber voltage caused by a radiation field is measured in the reader. This drop in voltage is a measure of the total integrated ionization caused by the radiation. The different size and wall thickness ion chambers cover the possible range of photon energy and doses. This device is very stable over time and may be used for accurate source calibration and inter-comparison dosimetry measurements.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
788084705
Device count
1
Serial number
true
Manufacturing date on label
true

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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