FDA.reportPublic FDA data

ASM SRC LS-EXACT LINE SRCS

Primary DI
04056869989075
Brand
ASM SRC LS-EXACT LINE SRCS
Company
SIEMENS MEDICAL SOLUTIONS USA, INC.
Model
11593892
Published
2023-06-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
IXDSource, calibration, sealed, nuclear

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IXDSource, Calibration, Sealed, NuclearRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04056869989075PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04056869989075040568699890754056869989075

GMDN Terms#

Term, Definition table
TermDefinition
Nuclear medicine phantom, test objectA device that includes a wide variety of two or three-dimensional (3-D) phantoms used in both calibration protocols and in subjective and quantitative evaluations of the performance of diagnostic nuclear medicine (NM) detector systems, e.g., gamma cameras, single photon emission computed tomography (SPECT), positron emission tomography (PET) or associated image display system and software programs. It consists of either fixed or variable configurations or patterns of absorbing or attenuating materials and radioactive source holders. The design can incorporate radioactive sealed sources or refillable radioactive source wells to which radioactivity can be added.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)888-7436CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
868230876
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04056869001371Biograph mCT Flow 20-3R10528956105289562016-09-24
04056869264745Symbia Pro.specta Q311364751113647512022-02-21
04056869264769Symbia Pro.specta X711364753113647532022-02-21
04056869264752Symbia Pro.specta X311364752113647522021-06-23
04056869001210Symbia_Intevo_Excel107648012016-09-24
04056869001289Biograph mCT-S (20) -3R105077862016-09-24
04056869001296Biograph mCT S(20)-3R105341592016-09-24
040568692435737L2 Transducer112895622020-05-14
04056869055466L10-5v Transducer113196822018-03-10
0405686905921118H5 Transducer112849242018-02-20
04056869002828ACUSON X300 Diagnostic Ultrasound System100374092016-09-24
04056869002750ACUSON S1000 Diagnostic Ultrasound System104417012016-09-24
04056869002767ACUSON S2000 Automated Breast Volume Scanner104347302016-09-24
04056869002774ACUSON S2000 Diagnostic Ultrasound System100414612016-09-24
04056869002781ACUSON S2000 Diagnostic Ultrasound System104400172016-09-24
04056869002798ACUSON S3000 Diagnostic Ultrasound System104417302016-09-24
04056869002811ACUSON X150 Diagnostic Ultrasound System101316612016-09-24
04056869002835ACUSON X300 PE Diagnostic Ultrasound System105661442016-09-24
04056869002859ACUSON X700 Diagnostic Ultrasound System106588442016-09-24
04056869004297Acuson NX3 Diagnostic Ultrasound System112356122016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810117211387Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.IXD2026-05-14
00810117211370Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.IXD2025-10-30
00810117211332Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.IXD2024-11-05
04068151007923ASM, LS-15 ROD SRCSIEMENS MEDICAL SOLUTIONS USA, INC.IXD2023-11-29
04068151007930ASM, CS-7 QC PHANTOMSIEMENS MEDICAL SOLUTIONS USA, INC.IXD2023-11-29
00850055164017Sanders Medical ProductsSanders Medical Products, Inc.IXD2023-07-27
04056869989082ASM SRC LS-HR+ LINE SRCSSIEMENS MEDICAL SOLUTIONS USA, INC.IXD2023-06-06
04056869989099ASM LINE SRC LS-30 HRRTSIEMENS MEDICAL SOLUTIONS USA, INC.IXD2023-06-06
04056869989105ASM LINE SOURCE MR-PETSIEMENS MEDICAL SOLUTIONS USA, INC.IXD2023-06-06
04056869989112ASSEMBLY MR PET QC PHANTOMSIEMENS MEDICAL SOLUTIONS USA, INC.IXD2023-06-06
04056869989129SM SRC CS-20-1 UNIFORM PHANTOMSIEMENS MEDICAL SOLUTIONS USA, INC.IXD2023-06-06
04056869989136SRC PHANTOM CS 20-2 GE68 2 MCI PLYUSIEMENS MEDICAL SOLUTIONS USA, INC.IXD2023-06-06
04056869989143ASM SRC CS-20-3 UNIFORM PHANTOMSIEMENS MEDICAL SOLUTIONS USA, INC.IXD2023-06-06
04056869989150SRC CS-HT-27-2 UNIFORM PHANTOMSIEMENS MEDICAL SOLUTIONS USA, INC.IXD2023-06-06
04056869989068ASM ACCEL LINE SRCSSIEMENS MEDICAL SOLUTIONS USA, INC.IXD2023-06-05
04056869989051ASM SRC LS-LA DET SET UP RODSIEMENS MEDICAL SOLUTIONS USA, INC.IXD2023-06-01
00810117211318Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.IXD2023-01-31
00810117210014Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.IXD2022-12-07
00810117210021Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.IXD2022-12-07
00810117210038Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.IXD2022-12-07
00810117210045Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.IXD2022-12-07
00810117210052Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.IXD2022-12-07
00810117210069Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.IXD2022-12-07
00810117210076Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.IXD2022-12-07
00810117210083Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.IXD2022-12-07
00810117210090Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.IXD2022-12-07
00810117210106Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.IXD2022-12-07
00810117210113Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.IXD2022-12-07
00810117210120Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.IXD2022-12-07
00810117210137Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.IXD2022-12-07