Search Results
Found 1 results
510(k) Data Aggregation
K Number
K070884Device Name
POD B-SCAN
Manufacturer
Date Cleared
2007-04-11
(12 days)
Product Code
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
STARFISH PRODUCT ENGINEERING INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The POD B-Scan is intended to be used for visualization by ultrasound of the eye and orbit by A-scan and B-scan.
The POD B-Scan System is a multi-purpose computer-based ultrasound diagnostic system for ophthalmic applications, intended to both visualize the interior of the eye by means of ultrasound and to make measurements inside the eye.
Device Description
The POD B-Scan is intended to be used for visualization by ultrasound of the eve and orbit by A-scan and B-scan.
The system is PC-based, and can be used with 35 MHz or 50MHz transducers. Because of the higher frequency of the transducers, it is expected that its greatest field of application will be in visualizing the anterior segment, because the focus area is about 11 mm from the transducer plane. The system can visualize other parts of the eye.
Summary of the reaconventional ophthalmic A and B-scan system using a motor-driven transducer and angle sensor for scanning. The A-scan is derived from the B-scan. There is a choice of transducer frequency of 35 MHz or 50 MHz. It uses a motor-driven 10 MHz transducer with an attached angle encoder. The system is PC-based, and the display is on the computer screen.
Ask a Question
Ask a specific question about this device
Page 1 of 1