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Found 5 results
510(k) Data Aggregation
K Number
K121422Device Name
APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM
Manufacturer
TOSHIBA MEDICAL SYSTEMS COPORATION, JAPAN
Date Cleared
2012-08-16
(94 days)
Product Code
IYO, ITX, IYN
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
TOSHIBA MEDICAL SYSTEMS COPORATION, JAPAN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DIAGNOSTIC ULTRASOUND SYSTEM APLIO 500 MODEL TUS-A500, APLIO 400 MODEL TUS-A400 and APLIO 300 MODEL TUS-A300 is indicated for the visualization of structures, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, intra-operative (abdominal), pediatric, small organs, trans-vaginal, trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatric), peripheral vascular, transesophageal, and musculoskeletal (both conventional and superficial).
Device Description
The DIAGNOSTIC ULTRASOUND SYSTEM APLIO 500 MODEL TUS-A500. APLIO 400 MODEL TUS-A400 and APLIO 300 MODEL TUS-A300 are mobile system. These systems are Track 3 devices that employ a wide array of probes that include flat linear array, convex linear array, and sector array with a frequency range of approximately 2 MHz to 12 MHz.
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K Number
K113466Device Name
AQUILION ONE
Manufacturer
TOSHIBA MEDICAL SYSTEMS COPORATION, JAPAN
Date Cleared
2012-04-10
(140 days)
Product Code
JAK
Regulation Number
892.1750Why did this record match?
Applicant Name (Manufacturer) :
TOSHIBA MEDICAL SYSTEMS COPORATION, JAPAN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K112366Device Name
4CH FLEX SPEEDER
Manufacturer
TOSHIBA MEDICAL SYSTEMS COPORATION, JAPAN
Date Cleared
2011-09-15
(29 days)
Product Code
MOS
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
TOSHIBA MEDICAL SYSTEMS COPORATION, JAPAN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- Imaging of the extremities (Foot and Hand), joints (knee, shoulder, ankie, wrist and elbow), and body (chest, abdomen and pelvis). MJAJ-192A is intended to be used on the Toshiba Vantage Titan 3T MR System.
Device Description
The 4ch Flex SPEEDER (MJAJ-192A), is a phased array coil that can receive NMR signal from the extremities, joints, and trunk of the human body. The 4ch Flex SPEEDER is mechanically flexible, and can wrap around various regions mentioned above. The 4ch Flex SPEEDER (MAJA-192A) consists of four coil elements and PC board. The coil elements shape single loop and the four single loop coil elements are arranged to the row. The coil is decoupled during transmission from QD whole body by means of activating the PIN diodes. MJAJ-192A is intended to be used on the Toshiba Vantage Titan 3T MR System.
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K Number
K110785Device Name
KALARE DIAGNOSTIC X-RAY TABLE SYSTEM
Manufacturer
TOSHIBA MEDICAL SYSTEMS COPORATION, JAPAN
Date Cleared
2011-05-27
(67 days)
Product Code
JAA
Regulation Number
892.1650Why did this record match?
Applicant Name (Manufacturer) :
TOSHIBA MEDICAL SYSTEMS COPORATION, JAPAN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations. Intended for use by a qualified/trained doctor or technologist on both adult and pediatric subjects taking diagnostic radiographic and fluoroscopic exposures of the whole body, skull, spinal column, chest, abdomen, extremities and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
Device Description
The main function of the KALARE (DREX-KL80) is to perform fluoroscopy/radiography of the examinations of the gastrointestinal tract examination, support for endoscopy, nonvascular contrast study, general abdominal radiography and general skeletal radiography. Using fluorescent scintillation effects of X-rays that have passed through the patient's body. image information is obtained for medical diagnosis and treatment.
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K Number
K111251Device Name
4CH FLEX SPEEDER
Manufacturer
TOSHIBA MEDICAL SYSTEMS COPORATION, JAPAN
Date Cleared
2011-05-27
(23 days)
Product Code
MOS
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
TOSHIBA MEDICAL SYSTEMS COPORATION, JAPAN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Imaging of the extremities (Foot and Hand), joints (knee, shoulder, ankle, wrist and elbow), and body (chest, abdomen and pelvis)
Device Description
The 4ch Flex SPEEDER is a phased array coil that can receive NMR signal from the extremities, joints, and trunk of the body. The 4ch Flex SPEEDER is mechanically flexible, and can wrap around various regions as mentioned above. The 4ch Flex SPEEDER consists of four coil elements and PC board. The coil elements shape single loop and the four single loop coil elements are arranged to the row. The coil is decoupled during transmission from QD whole body by means of activating the PIN diodes.
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