FDA.reportPublic FDA data

ASM ACCEL LINE SRCS

Primary DI
04056869989068
Brand
ASM ACCEL LINE SRCS
Company
SIEMENS MEDICAL SOLUTIONS USA, INC.
Model
11593891
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
04056869989068PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04056869989068040568699890684056869989068

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
04056869250144syngo Utrasound Breast Analysis115078592023-06-29
04056869235417syngo Ultrasound Apps Suite (sUSAS)112911942019-11-26
04056869001067sUSBA Software, VA25A108556712016-09-24
04056869001074sUSBA SW, VA20B108534992016-09-24
04056869003511syngo Ultrasound Apps Suite (sUSAS)111486662016-09-24
04056869006833sUSBA Software111499252018-03-12
04056869006840sUSBA Trial Software111499262018-03-12
04056869063287sUSAS112875792018-03-12
04056869269429Biograph Vision Quadra10754273107542732023-01-12
04068151012477ACUSON Origin ICE Diagnostic Ultrasound System11669400116694002024-08-22
04056869996295ACUSON Origin Diagnostic Ultrasound System11668590116685902023-12-19
04056869981062ACUSON Sequoia Select Diagnostic Ultrasound System11658635116586352023-04-21
04056869173566ACUSON Sequoia Diagnostic Ultrasound System11148775111487752018-05-07
04068151049923MI View&GO11589575115895752026-06-10
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

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
04056869989075ASM SRC LS-EXACT 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