FDA.reportPublic FDA data

RadQual

Primary DI
00850020470020
Brand
RadQual
Company
RADQUAL, LLC
Model
BM04
Device description
"Rect 14"" x 18"" Phantom Co 57"
Published
2020-08-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IYQPhantom, Flood Source, Nuclear

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYQPhantom, Flood Source, NuclearRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850020470020PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850020470020008500204700208500204700200850020470020

GMDN Terms#

Term, Definition table
TermDefinition
Nuclear medicine phantom, flood sourceA device which is either a radioactive sealed source or a water-filled radiolucent disc or other shape to which radioactivity can be added. It is a quality assurance (QA) device used in both subjective and quantitative evaluations of various calibration and performance characteristics of photon detector systems used in nuclear medicine applications and associated image acquisition, display, and analysis computer programs.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008841076
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850020470037RadQualBM052020-08-07
00850020470044RadQualBM072020-08-07
00850020470051RadQualBM552020-08-07
00850020470068RadQualBM032020-08-03
00850020470075RadQualBM03-22A2020-08-03
00850020470082RadQualBM03-137L2020-08-03
00850020470099RadQualBM03-22L2020-08-03
00850020470105RadQualBM03-22L-PET2020-08-03
00850020470112RadQualBM03-57A2020-08-03
00850020470129RadQualBM03-57L2020-08-03
00850020470136RadQualBM03-57 L&R2020-08-03
00850020470143RadQualBM03-68A2020-08-03
00850020470150RadQualBM03-68L-10C2020-08-03
00850020470167RadQualBM03-68L2020-08-03
00850020470174RadQualBM03-133L2020-08-03
00850020470181RadQualBM06E-332020-08-03
00850020470198RadQualBM06E-372020-08-03
00850020470204RadQualBM06E-572020-08-03
00850020470211RadQualBM06E-602020-08-03
00850020470228RadQualBM06S-332020-08-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810117211363Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.IYQ2025-10-30
00850055164000Sanders Medical ProductsSanders Medical Products, Inc.IYQ2023-07-27
00810117210359Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.IYQ2022-12-07
00810117210366Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.IYQ2022-12-07
00810117210373Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.IYQ2022-12-07
00810117210380Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.IYQ2022-12-07
00810117210397Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.IYQ2022-12-07
00810117210403Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.IYQ2022-12-07
00810117210410Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.IYQ2022-12-07
00810117210427Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.IYQ2022-12-07
00810117210434Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.IYQ2022-12-07
00810117210441Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.IYQ2022-12-07
00810117210458Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.IYQ2022-12-07
00810117210465Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.IYQ2022-12-07
00810117210472Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.IYQ2022-12-07
00810117210489Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.IYQ2022-12-07
00810117210496Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.IYQ2022-12-07
00810117210502Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.IYQ2022-12-07
00810117210519Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.IYQ2022-12-07
00810117210526Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.IYQ2022-12-07
00810117210533Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.IYQ2022-12-07
00810117210540Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.IYQ2022-12-07
00810117210557Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.IYQ2022-12-07
00810117210564Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.IYQ2022-12-07
00810117210571Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.IYQ2022-12-07
00810117210588Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.IYQ2022-12-07
00810117210595Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.IYQ2022-12-07
00810117210601Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.IYQ2022-12-07
00810117210618Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.IYQ2022-12-07
00810117210625Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.IYQ2022-12-07