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510(k) Data Aggregation
K Number
K103608Device Name
I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND
Manufacturer
ELLEX, INC.
Date Cleared
2010-12-27
(18 days)
Product Code
IYO
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
ELLEX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Eye Cubed V4 is indicated for use in ophthalmic imaging when the following conditions are present or suspected:
- Cataracts
- Retinal Detachments (a separation of the retina from the middle coat of the eyeball)
- Orbital Lesions
- Tumors
- Foreign bodies
- Inflammation
- Vascular Irregularities
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Ophthalmic: A, B, M, PWD, CWD, Colour Doppler, Amplitude Doppler, Colour Velocity Imaging, Combined (specify), Other (specify)
Specific transducer intended uses:
Ophthalmic 40 MHz Anterior Segment B-scan transducer: Anterior 40 MHz B-scan imaging of the eye
Ophthalmic 10 MHz Posterior Segment B-scan transducer: Posterior 10 MHz B-scan imaging of the eye
Ophthalmic 10 MHz Biometric A-scan transducer: 10 MHz Biometric A-scan imaging of the eye
Ophthalmic 8 MHz Diagnostic A-scan transducer: 8 MHz Diagnostic A-scan imaging of the eye
Ophthalmic 20 MHz Anterior Segment B-scan transducer: Anterior 20 MHz B-scan imaging of the eye
Device Description
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K Number
K083061Device Name
ELLEX INNOVATIVE IMAGING EYE CUBED V4
Manufacturer
ELLEX, INC.
Date Cleared
2009-01-09
(87 days)
Product Code
IYO
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
ELLEX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Posterior 10MHz B-scan Imaging of the Eye; 10MHz Biometric A-scan Imaging of the Eye; 8MHz Diagnostic A-scan Imaging of the Eye; Anterior 20MHz B-scan Imaging of the Eye.
Device Description
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