Search Results
Found 11 results
510(k) Data Aggregation
K Number
K163289Device Name
syngo. CT Single Source Dual Energy (twin beam)
Manufacturer
SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI
Date Cleared
2017-02-09
(79 days)
Product Code
JAK, SYN
Regulation Number
892.1750Why did this record match?
Applicant Name (Manufacturer) :
SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
syngo. CT Single Source Dual Energy is designed to operate with CT images which have been acquired with Siemens Twin Beam Single Source scanners. The various materials of an anatomical region of interest have different attenuation coefficients, which depend on the used energy. These differences provide information on the chemical composition of the scanned body materials. syngo.CT Single Source Dual Energy combines images acquired with low and high energy spectra to visualize this information. Depending on the region of interest, contrast agents may be used.
The functionality of the syngo. CT Single Source Dual Energy applications are as follows:
- · Monoenergetic
- · Bone Removal
- · Liver VNC
- · Lung Analysis
- · Gout Evaluation
- · Monoenergetic Plus
- · Virtual Unenhanced
- · Rho/Z
- · Hard Plaques
-
- · Kidney Stones *
*) Kidney Stones is designed to support the visualization of the chemical composition of kidney stones and especially the differentiation between uric acid and non-uric acid stones. For full identification of the kidney stone additional clinical clinical information should be considered such as patient history and urine testing. Only a well-trained radiologist can make the final diagnosis under consideration of all available information. The accuracy of identification is decreased in obese patients.
Device Description
syngo.CT Single Source Dual Energy (twin beam) Software Package is a post processing application package consisting of several post-processing application classes that can be used to improve visualization of various energy dependent materials in the human body. This software application is designed to operate on the most recent version syngo.via client/server platform, which supports preprocessing and loading of datasets by syngo.via depending on configurable rules.
After loading the two reconstructed image datasets acquired with two different X-ray spectra into syngo.CT Single Source Dual Energy (twin beam), a correction algorithm is used in order to minimize motion effects. They are then displayed using linear blending with selectable mixing ratio and color scale. Multiplanar reformations (MPR) of the volume are shown in 3 image segments, which are initialized as sagittal, coronal and axial view. After arriving at an initial diagnosis on the basis of the CT-images, the user can choose one of the following application classes:
- . Monoenergetic
- Bone Removal ●
- Liver VNC
- Lung Analysis
- Gout Evaluation ●
- Monoenergetic Plus ●
- Virtual Unenhanced .
- Rho/Z ●
- Hard Plaques .
- Kidney Stones .
These application classes are designed for specific clinical tasks, so that algorithms, additional tool buttons, the use of colored overlay images and image representation (for example MPR or maximum intensity projection) is optimized correspondingly.
Ask a Question
K Number
K113179Device Name
ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM
Manufacturer
SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI
Date Cleared
2011-12-07
(40 days)
Product Code
IYN, ITX, IYO
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Intrcperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. The typical examinations performed using the SC2000 Ultrasound System are: Cardiac Imaging Applications and Analysis, Vascular Imaging Applications and Analysis, Superficial Imaging Applications, Intraoperative Imaging Applications, Transcranial Imaging Applications.
Device Description
The SC2000™ Diagnostic Ultrasound System is a multi-purpose mobile, software controlled diagnostic ultrasound system with an on-screen display for themical indices related to potential bio-effect mechanisms. Its function is to acquire primary of Secondary harmonic ultrasound echo data and display it in B-Mode, Pulsed (PW) Dopler Mode, a combination Continuous (CW) Doppler Mode, Color Dopen Mode, Ampling on a France, Nissalay of modes, 3D Imaging, or Harmonic Imaging and 4D imaging on a Flat Panel Display. The SC2000™Ultrasound System has been optimized for user ergonomics with adjustable keyboard height and rotation and independently adjustable Flat P available off-line workstation (SC2000WP).
Ask a Question
K Number
K112596Device Name
ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM
Manufacturer
SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI
Date Cleared
2011-09-16
(9 days)
Product Code
IYN, ITX, IYO
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The S2000™ ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
The system also provides the ability to measure anatomical structures {fetal, abdominal. intraoperative, intraoperative neurological, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, trans-esophageal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging".
The Acuson Acunav Ultrsound Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart of adult and pediatric patients.
Device Description
The S2000™ Ultrasound System is a multi-purpose mobile, software controlled diagnostic ultrasound system with and on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, or Harmonic Imaging and 3D/4D Imaging on a Flat Panel Display.
Ask a Question
K Number
K081148Device Name
SIEMENS ACUSON 2000 ULTRASOUND SYSTEM WITH ABVS TRANSDUCER
Manufacturer
SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI
Date Cleared
2008-12-22
(244 days)
Product Code
IYO, ITX, IYN
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Modified S2000, the S2000 ABVS Ultrasound System, is intended for the following The Modified Beeral Radiology, Abdominal, Fetal, Small Parts, Transcranial, OB/GYN, apprications: Contral News Cephalic, Pediatric, Urology, Vascular, Musculoskeletal, Supericial Musculoskeletal, and Peripheral Vascular applications. The system supports the Superilean Massantanteretalters for Use tables, including the 14LSBV for Bmode imaging of a patient's breast using an optional automatic scanning function. The device is not intended to be used as a replacement for screening mammography.
The system also provides for the measurement of anatomical structures and analysis as provided in the original S2000 Ultrasound System, which provides information that is used by medical heulth care professionals for clinical diagnosis purposes.
Device Description
The Acuson S2000 ABVS Ultrasound System has been designed to meet the following product safety standards:
- UL 60601-1, Safety Requirements for Medical Equipment .
- I IFC 60601-2-37 Diagnostic Ultrasound Safety Standards
- CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment D
- AJUM/NEMA UD-3, 1998 Standard for Real Time Display of Thermal and 이 Mcchanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- AIUM/NEMA UD-2, 1998 Acoustic Output Measurcment Standard for Diagnostic 1 Ultrasound
- l 93/42/EEC Medical Devices Directive
- Safety and EMC Requirements for Medical Equipment L
- . EN/IEC 60601-1
- 8 EN/IEC 60601-1-1
- B EN/IEC 60601-1-2
- IEC 1157 Declaration of Acoustic Power .
- . ISO 10993-1 Biocompatibility
Ask a Question
K Number
K082142Device Name
ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM
Manufacturer
SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI
Date Cleared
2008-11-13
(106 days)
Product Code
IYN, ITX, IYO
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The S2000™ ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, intraoperative neurological, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, trans-esophageal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
Device Description
The Acuson S2000™ has been designed to meet the following product safety standards:
- UL 60601-1, Safety Requirements for Medical Equipment
- IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
- CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment
- AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical l Acoustic Output Indices on Diagnostic Ultrasound Equipment
- AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound
- 93/42/EEC Medical Devices Directive
- Safety and EMC Requirements for Medical Equipment
- EN/IEC 60601-1
- EN/IEC 60601-1-1
- EN/IEC 60601-1-2
- IEC 1157 Declaration of Acoustic Power
- ISO 10993-1 Biocompatibility
Ask a Question
K Number
K081121Device Name
MODIFICATION TO ACUSON X150 ULTRASOUND SYSTEM
Manufacturer
SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI
Date Cleared
2008-06-04
(44 days)
Product Code
IYO, ITX, IYN
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Siemens ACUSON X150 ultrasound imaging system is intended for the following applications: General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Neonatal/Adult Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial, OB/GYN, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
Diagnostic imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Intraoperative (abdominal, vascular), Pediatric, Small Organ (breast, testes, thyroid, penis, prostate, etc.), Neonatal Cephalic, Adult Cephalic, Cardiac, Transesophageal, Transrectal, Transvaginal, Transurethral, Intravascular, Peripheral vessel, Laparoscopic, Musculo-skeletal Conventional, Musculo-skeletal Superficial.
Device Description
The Siemens ACUSON X150 ultrasound system is a multi-purpose diagnostic ultrasound system with accessories and proprietary software.
Ask a Question
K Number
K080760Device Name
ACUSON X300 ULTRASOUND SYSTEM
Manufacturer
SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI
Date Cleared
2008-04-25
(38 days)
Product Code
IYN, DQO, ITX, IYO
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Siemens ACUSON X300 ultrasound imaging system is intended for the following applications: General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Neonatal/Adult Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial, OB/GYN, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
Diagnostic imaging or fluid flow analysis of the human body as follows: (followed by tables detailing specific applications and modes of operation for various transducers).
Device Description
The Siemens ACUSON X300 has been designed to meet the following product safety standards:
- UL 60601-1, Safety Requirements for Medical Equipment
- I IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
- I CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment
- AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- 1 AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound
- 93/42/EEC Medical Devices Directive
- . Safety and EMC Requirements for Medical Equipment
- 트 EN/IEC 60601-1
- 요 EN/IEC 60601-1-1
- 트 EN/IEC 60601-1-2
- 트 EN/EC 60601-1-4
- 이 EN/EC 60601-1-6
- . EN/IEC 60601-2-18
- 피 EN/EC 60601-2-25
- I IEC 61157 Declaration of Acoustic Power
- ISO 10993-1 Biocompatibility
Ask a Question
K Number
K072365Device Name
SEQUOIA PLUS DIAGNOSTIC ULTRASOUND SYSTEM
Manufacturer
SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI
Date Cleared
2007-10-17
(55 days)
Product Code
IYN, ITX, IYO
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Ultrasound imaging or fluid flow analysis of the human body as follows: Cardiac, Neonatal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Intraoperative Neurological, Musculo-skelctal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
Device Description
The Siemens Sequoia™ Plus has been designed to meet the following product safety standards: UL 60601-1, Safety Requirements for Medical Equipment; IEC 60601-2-37 Diagnostic Ultrasound Safety Standards; CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment; AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment; AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound; 93/42/EEC Medical Devices Directive; Safety and EMC Requirements for Medical Equipment EN/IEC 60601-1, EN/IEC 60601-1-1, EN/IEC 60601-1-2; IEC 1157 Declaration of Acoustic Power; ISO 10993-1 Biocompatibility.
Ask a Question
K Number
K072090Device Name
SIEMENS DIAGNOSTIC ULTRASOUND SYSTEMS
Manufacturer
SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI
Date Cleared
2007-09-14
(46 days)
Product Code
IYN
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Siemens ultrasound imaging systems are intended for the following applications: General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Neonatal/Adult Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial, OB/GYN, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
Device Description
The modified software features provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
Ask a Question
K Number
K071036Device Name
MODIFICATION TO ACUSON X300 ULTRASOUND SYSTEM
Manufacturer
SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI
Date Cleared
2007-05-16
(34 days)
Product Code
IYN, DQO, ITX, IYO
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Diagnostic imaging or fluid flow analysis of the human body as follows: General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Neonatal/Adult Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial, OB/GYN, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
Device Description
The Siemens Acuson X300 has been designed to meet the following product safety standards: UL 60601-1, Safety Requirements for Medical Equipment; IEC 60601-2-37 Diagnostic Ultrasound Safety Standards; CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment; AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment; AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound; 93/42/EEC Medical Devices Directive; Safety and EMC Requirements for Medical Equipment EN/EC 60601-1, EN/IEC 60601-1-1, EN/IEC 60601-1-2; IEC 61157 Declaration of Acoustic Power; ISO 10993-1 Biocompatibility.
Ask a Question
Page 1 of 2