FDA.reportPublic FDA data

ACUSON SC2000 Diagnostic Ultrasound System

Primary DI
04056869002804
Brand
ACUSON SC2000 Diagnostic Ultrasound System
Company
SIEMENS MEDICAL SOLUTIONS USA, INC.
Model
10433816
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
ITXTransducer, ultrasonic, diagnostic
IYNSystem, imaging, pulsed doppler, ultrasonic
IYOSystem, imaging, pulsed echo, ultrasonic
LLZSystem, image processing, radiological
OBJCatheter, ultrasound, intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2
IYNSystem, Imaging, Pulsed Doppler, UltrasonicRadiology2
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2
LLZSystem, Image Processing, RadiologicalRadiology2
OBJCatheter, Ultrasound, IntravascularCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102017000
K113179000
K130754000
K132654000
K141846000
K142395000
K162221000
K170315000
K181098000
K202683000
K211726000
K233613000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102017000SC2000 DIAGNOSTIC ULTRASOUND SYSTEMSiemens Medical Solutions USA, Inc.2010-09-20IYN
K113179000ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEMSiemens Medical Solutions USA, Inc., Ultrasound DI2011-12-07IYN
K130754000ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEMSiemens Medi Cal Solutions, Inc.2013-03-25IYN
K132654000ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEMSiemens Medical Solutions USA, Inc. Ultrasound Gro2013-09-26IYO
K141846000ACUSON X700 ULTRASOUND SYSTEM, ACUSON X600 ULTRASOUND SYSTEMSiemens Medical Solutions USA, Inc.2014-08-07IYN
K142395000SC2000 and ACUSON X300 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2014-09-09IYO
K162221000ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions Inc. Ultrasound Group2016-09-06IYN
K170315000Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.2017-04-04IYN
K181098000ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2018-05-31IYN
K202683000ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System, ACUSON Freestyle Diagnostic Ultrasound System,ACUSON S1000, S2000, S3000 Diagnostic Ultrasound Systems, ACUSON P200 Diagnostic Ultrasound System, ACUSON P500 Diagnostic Ultrasound System, ACUSON NX3, NX3 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020-10-15IYN
K211726000Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2021-11-05IYO
K233613000ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2024-06-12IYO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04056869002804PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04056869002804040568690028044056869002804

GMDN Terms#

Term, Definition table
TermDefinition
Cardiovascular ultrasound imaging systemAn assembly of mains electricity (AC-powered) devices designed for extracorporeal and/or intracorporeal (endosonography or endoscopic) imaging procedures involving the heart and blood vessels. Included are software packages that support a variety of static or real-time cardiac specific imaging applications used to diagnose anatomical defects of the heart, determine blood flow characteristics and functional/anatomical problems associated with myocardial infarction. It is used to generate ultrasound pulses, direct them to a target area, detect the echoes, and process the resulting information to produce and display static or dynamic two or three-dimensional (3-D) images.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
804722783
Device count
1
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

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Primary DI, Brand, Company table
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B359OAIIV2026051RamsoftRamsoft IncLLZ2026-06-04
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