Search Results
Found 25 results
510(k) Data Aggregation
K Number
K082224Device Name
DIAGNOSTIC ULTRASOUND SYSTEM SARANO, ECHO VIEW, SHIMASONIC
Manufacturer
SHIMADZU MEDICAL SYSTEMS
Date Cleared
2008-12-15
(131 days)
Product Code
ITX, IYO
Regulation Number
892.1570Why did this record match?
Applicant Name (Manufacturer) :
SHIMADZU MEDICAL SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Fetal, Abdominal, Pediatric, Small Organs (Thyroid, Testicles, Breast), Neonatal Cephalic, Adult Cephalic, Cardiac, Transvaginal, Peripheral Vascular, Musculo-skeletal Superficial and Musculo-skeletal Conventional, Transrectal.
Device Description
The sarano is a mobile diagnostic ultrasound system. This system has flat linear array, convex and with a frequency range of approximately 2 to 15 MHz. It has B mode, M mode, or in a combination of modes. Also the sarano has two kinds of monitor; CRT and LCD. The former is standard model and latter is optional model.
Ask a Question
K Number
K071287Device Name
ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND DEVICE, MODEL SDU-2200PRO
Manufacturer
SHIMADZU MEDICAL SYSTEMS
Date Cleared
2008-01-09
(246 days)
Product Code
ITX, IYN, IYO
Regulation Number
892.1570Why did this record match?
Applicant Name (Manufacturer) :
SHIMADZU MEDICAL SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Fetal, Abdominal, Pediatric, Small Organs (Specify), Neonatal Cephalic, Adult Cephalic, Cardiac, Transvaginal, Peripheral Vascular, Musculo-skeletal Superficial and Musculo-skeletal Conventional.
Small Organ (Specify): Thyroid, Testicles, Breast.
Device Description
The SDU-2200Pro is a mobile diagnostic ultrasound system. This system has flat linear array, convex linear and sector probe with a frequency range of approximately 2 to 15 MHz. It has B mode, M mode, Pulsed Doppler mode, Continuous Doppler mode, Color mode, Real time 3D mode, or in a combination of modes.
Ask a Question
K Number
K071289Device Name
ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO
Manufacturer
SHIMADZU MEDICAL SYSTEMS
Date Cleared
2008-01-09
(246 days)
Product Code
ITX, IYN, IYO
Regulation Number
892.1570Why did this record match?
Applicant Name (Manufacturer) :
SHIMADZU MEDICAL SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Fetal, Abdominal, Pediatric, Small Organs (Thyroid, Testicles, Breast), Neonatal Cephalic, Adult Cephalic, Cardiac, Transvaginal, Peripheral Vascular, Musculo-skeletal Superficial and Musculo-skeletal Conventional, Transrectal.
Device Description
The SDU-1200Pro is a mobile diagnostic ultrasound system. This system has flat linear array, convex linear and sector probe with a frequency range of approximately 1.5 to 15 MHz. It has B mode, M mode, Pulsed Doppler mode, Continuous Doppler mode, Real time 3D mode, Color mode, or in a combination of modes.
Ask a Question
K Number
K071291Device Name
ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100
Manufacturer
SHIMADZU MEDICAL SYSTEMS
Date Cleared
2008-01-09
(246 days)
Product Code
ITX, IYN, IYO
Regulation Number
892.1570Why did this record match?
Applicant Name (Manufacturer) :
SHIMADZU MEDICAL SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Fetal, Abdominal, Pediatric, Small Organs (Specify), Neonatal Cephalic, Adult Cephalic, Cardiac, Transrectal, Transvaginal, Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial. Small Organ (Specify): Thyroid, Testicles, Breast. Other (Specify): Real time 3D.
Device Description
The SDU-1100 is a mobile diagnostic ultrasound system. This system has flat linear array, convex linear and sector probe with a frequency range of approximately 2 to 15 MHz. It has B mode, M mode, Pulsed Doppler mode, Real time 3D mode, Color mode, or in a combination of modes.
Ask a Question
K Number
K061643Device Name
ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO
Manufacturer
SHIMADZU MEDICAL SYSTEMS
Date Cleared
2006-07-27
(45 days)
Product Code
IYN, ITX, IYO
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
SHIMADZU MEDICAL SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Fetal, Abdominal, Pediatric, Small Organs (Thyroid, Testicles, Breast), Neonatal Cephalic, Adult Cephalic, Cardiac, Transvaginal, Transrectal, Peripheral Vascular, Musculo-skeletal Conventional, and Musculo-skeletal Superficial.
Device Description
The SDU-1200Pro is a mobile diagnostic ultrasound system. This system has flat linear array, convex linear and sector probe with a frequency range of approximately 1.5 to 15 MHz. It has B mode, M mode, Pulsed Doppler mode, Continuous Doppler mode, Color mode, or in a combination of modes.
Ask a Question
K Number
K061637Device Name
ECHOVIEW/ SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-2200PRO
Manufacturer
SHIMADZU MEDICAL SYSTEMS
Date Cleared
2006-07-25
(43 days)
Product Code
IYN, ITX, IYO
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
SHIMADZU MEDICAL SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Fetal, Abdominal, Pediatric, Small Organs (Thyroid, Testicles, Breast), Neonatal Cephalic, Adult Cephalic, Cardiac, Transvaginal, Peripheral Vascular, Musculo-skeletal Superficial and Musculo-skeletal Conventional, Transrectal.
Mode of Operation: A, B, M, PWD, CWD, Color Doppler, Power (Amplitude) Doppler, Color Velocity Imaging, Combined (B/M, B/PWD, CFM(B)/PWD, CFM(B)/CFM(M), B/CWD, CFM(B)/CWD), Tissue Harmonic Imaging.
Device Description
The SDU-2200Pro is a mobile diagnostic ultrasound system. This system has flat linear array, convex linear and sector probe with a frequency range of approximately 2 to 15 MHz. It has B mode, M mode, Pulsed Doppler mode, Continuous Doppler mode, Color mode, or in a combination of modes.
Ask a Question
K Number
K061641Device Name
ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SARANO
Manufacturer
SHIMADZU MEDICAL SYSTEMS
Date Cleared
2006-07-14
(32 days)
Product Code
IYO, DAT
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
SHIMADZU MEDICAL SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Fetal, Abdominal, Pediatric, Small Organs (Thyroid, Testicles, Breast), Neonatal Cephalic, Adult Cephalic, Cardiac, Transvaginal, Peripheral Vascular, Muscular, Musculo-skeletal Superficial and Musculo-skeletal Conventional, Transrectal.
Device Description
The sarano is a mobile diagnostic ultrasound system. This system has flat linear array, convex linear and with a frequency range of approximately 2 to 15 MHz. It has B mode, M mode, or in a combination of modes.
Ask a Question
K Number
K052500Device Name
DAR-8000F
Manufacturer
SHIMADZU MEDICAL SYSTEMS
Date Cleared
2005-10-17
(34 days)
Product Code
IZI
Regulation Number
892.1600Why did this record match?
Applicant Name (Manufacturer) :
SHIMADZU MEDICAL SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is intended to be used for the radiography in the hospital with X-ray devices. The object of this device is total patient population. As mentioned at "Intended Use" in this clearance letter, the intended use of DAR-8000f is the same as that of predicate device of DAR-7000(K050925). Consequently, the indications for use of DAR-8000f are also the same as that of DAR-7000, and there are no additional indications.
Device Description
Not Found
Ask a Question
K Number
K052076Device Name
DAR-8000I
Manufacturer
SHIMADZU MEDICAL SYSTEMS
Date Cleared
2005-09-02
(32 days)
Product Code
IZI
Regulation Number
892.1600Why did this record match?
Applicant Name (Manufacturer) :
SHIMADZU MEDICAL SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is intended to be used for radiography in the hospital with X-ray devices.
Device Description
Not Found
Ask a Question
K Number
K050510Device Name
ECHOVIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100
Manufacturer
SHIMADZU MEDICAL SYSTEMS
Date Cleared
2005-04-01
(31 days)
Product Code
IYN, ITX, IYO
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
SHIMADZU MEDICAL SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Fetal, Abdominal, Pediatric, Small Organs (Thyroid, Testicles, Breast), Neonatal Cephalic, Adult Cephalic, Cardiac, Transvaginal, Peripheral Vascular, Musculo-skeletal Superficial and Musculo-skeletal Conventional, Transrectal.
Device Description
The SDU-1100 is a mobile diagnostic ultrasound system. This system has flat linear array, convox array, and sector probe with a frequency range of approximately 2 to 15 MHz. The system can operate in B mode, M mode, Pulsed Doppler mode, Color mode, or in a combination of modes.
Ask a Question
Page 1 of 3