Search Results
Found 2 results
510(k) Data Aggregation
K Number
K041916Device Name
ALOKA SSD-ALPHA 5 ULTRASOUND SYSTEM
Manufacturer
ALOKA CO. LTD USA
Date Cleared
2004-07-30
(14 days)
Product Code
IYN, ITX, IYO
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
ALOKA CO. LTD USA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application: Fetal, Abdominal, Pediatric, Small Organ (specify), Neonatal Cephalic, Adult Cephalic, Cardiac, Transvaginal, Peripheral Vascular, Musculo-skeletal Superficial.
Modes of operation: B, M, PWD, CWD, Color Doppler, Amplitude Doppler.
Combined (specify): See Below
Additional Comments: Mixed mode operation includes BM, BPWD, MCD, B/CD/PWD, B/CD/CWD
Applications: Small Parts-breast, testes & thyroid, abdominal, gynecological, fetal, neonatal, cardiac.
Device Description
The Aloka SSD-Alpha 5 Ver. 1.0 diagnostic ultrasound system and transducers. High frequency sound waves are transmitted into the body by a piezo-electric transducer. In the body, differences in the acoustic impedance of different tissues reflect a certain amount of the ultrasound energy back to the transducer, where it is transmitted via the probe cable to the system console and processed into an image. The Aloka SSD-Alpha 5 transducers can also use the Doppler shift of sound reflected from moving tissues (blood) to detect and display flow.
Ask a Question
K Number
K032875Device Name
ALOKA MODEL SSD-5500 V6.0 ULTRASOUND SYSTEM
Manufacturer
ALOKA CO. LTD USA
Date Cleared
2003-09-30
(15 days)
Product Code
IYO
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
ALOKA CO. LTD USA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Intraoperative (specify), Intraoperative Neurological, Pediatric, Small Organ (specify), Neonatal Cephalic, Adult Cephalic, Cardiac, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, Laparoscopic, Musculo-skeletal Conventional, Musculo-skeletal Superficial. Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD. Intraoperative applications: include liver, pancreas and gall bladder. Small parts applications include breast, testes and thyroid.
Device Description
The Aloka SSD-5500 V6.0 functions in the same manner as other diagnostic ultrasound devices. High frequency sound waves are transmitted into the body by a piezo-electric transducer. In the body, differences in the acoustic impedance of different tissues reflect a certain amount of the ultrasound energy back to the transducer, where it is transmitted via the probe cable to the system console and processed into an image. The Aloka SSD-5500 V6.0 transducer can also use the Doppler shift of sound reflected from moving tissues (blood) to detect and display flow.
Ask a Question
Page 1 of 1