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510(k) Data Aggregation
K Number
K042885Device Name
OCT-OPTHALMOSCOPE
Manufacturer
OPHTHALMIC TECHNOLOGIES, INC.
Date Cleared
2005-01-21
(94 days)
Product Code
HLI, OBO
Regulation Number
886.1570Why did this record match?
Applicant Name (Manufacturer) :
OPHTHALMIC TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OTI OCT Ophthalmoscope is intended to offer simultaneous acquisition of highresolution transversal OCT (Optical Coherence Tomography) and confocal images of the eye fundus. It is indicated in situations where these images are required for diagnosis.
Device Description
The OTI OCT Ophthalmoscope produces simultaneous acquisition of highresolution transversal OCT (Optical Coherence Tomography) and confocal images of the eye fundus. In addition conventional longitudinal OCT images may also be collected. The system uses a high power superluminescient diode operating at 850nm. The software uses a tabbed interface: the user can select any of the primary functional modules at any time by clicking on the tab for that function at the top of the screen. When there are several major components in a function, these are presented as tabs below the principal tab bar.
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K Number
K031391Device Name
HF MODULE WITH TRANSDUCERS
Manufacturer
OPHTHALMIC TECHNOLOGIES, INC.
Date Cleared
2003-06-20
(49 days)
Product Code
IYO
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
OPHTHALMIC TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Transducer for B-scans with OTI-Scan HF Module Mode of Operation Ophthalmic
Device Description
The OTI-scan HF module is an ultrasonic ophthalmic B-scan system that uses the principles of sonar (pulsed ultrasound) to visualize and measure the interior of the eye with high-frequency transducers to obtain better accuracy.
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K Number
K030770Device Name
OTI SCAN WITH TRANSDUCERS
Manufacturer
OPHTHALMIC TECHNOLOGIES, INC.
Date Cleared
2003-03-27
(16 days)
Product Code
IYO
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
OPHTHALMIC TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OTI-scan ultrasound system is a multi-purpose personal-computer-based ultrasonic diagnosis system for ophthalmic applications, intended to both visualize the interior of the eye by means of ultrasound and to make measurements inside the eye, including the measurement of axial length for determination of IOL power.
Device Description
The OTI-scan is a compact Ultrasonic ophthalmic A-scan system and B-scan system that uses the principles of sonar (pulsed ultrasound) to measure the axial length of the eyes and to visualize the interior of the eye.
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K Number
K024114Device Name
A-SCAN 100
Manufacturer
OPHTHALMIC TECHNOLOGIES, INC.
Date Cleared
2003-01-10
(28 days)
Product Code
IYO
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
OPHTHALMIC TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The A-scan 100 is an ophthalmic A-scan system intended to be used for measurement of axial distances in the eye and for the calculation of the power of an implanted intraocular lens (IOL), indicated for patients requiring intraocular lenses.
Device Description
The A-scan 100 is a compact device Ultrasonic ophthalmic A-scan system that uses the principles of sonar (pulsed ultrasound) to measure the axial length of the eyes. The device includes four popular formulas to calculate the implanted IOL power, using the Ultrasound Axial Length measurement. The results may be printed through a PC computer printers.
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K Number
K990064Device Name
DI-RHEX OPHTHALMIC DIATHERMY SYSTEM
Manufacturer
OPHTHALMIC TECHNOLOGIES, INC.
Date Cleared
1999-04-04
(86 days)
Product Code
HQR
Regulation Number
886.4100Why did this record match?
Applicant Name (Manufacturer) :
OPHTHALMIC TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OTI Di-thex Ophthalmic Diathermy Unit is intended to be used for producing haemeostasis in the anterior and posterior segment of the eye, for conjunctival welding (coaptation), retinal coagulation using endodiathermy tips, and for cutting in ophthalmic surgery, using a high frequency current applied by a bipolar probe.
Device Description
The system consists of a central control unit that supplies radio frequency energy to a handpiece. The unit can be used for standard diathermy procedures, and can be also used as a cutting instrument for membrane dissection in the eye with the appropriate handpieces and tips. Power level is microprocessor-controlled, and the power-level setting is shown by a bar-graph display on the front panel. The system has a set of alarms which alert the user and suspend operation for such cases as overtemperature, overvoltage, and computer errors.
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K Number
K974522Device Name
3D I-SCAN
Manufacturer
OPHTHALMIC TECHNOLOGIES, INC.
Date Cleared
1998-02-25
(85 days)
Product Code
IYO
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
OPHTHALMIC TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ophthalmic Technologies Inc. (OTI) 3D i-scan is intended to be used as an accessory with the OTI i-scan Ophthalmic B-scan Ultrasound system (K960622) to provide a three-dimensional visualization of the interior of the globe. The device is indicated when it is desirable to have a three-dimensional depiction (perspective rendering) of the interior of the globe for diagnostic purposes.
Device Description
The 3D i-scan works in conjunction with the Ophthalmic Technologies Inc. (OTI) i-scan ophthalmic B-scan system. It automatically makes a series of 201 B-scans at different angles, and then combines them to produce a perspective image, called the "3D image." Scanning is done through a closed eye-lid. The 3D i-scan consists of a computer and computer monitor, and a mechanical scan assembly which holds the B-scan ultrasonic scanner and rotates it at a speed synchronized with the lateral scanning rate of the probe. Ultrasonic gel is used as a coupling medium between the transducer and the surface of the eye-lid. The computer system assembles the multiple images of the interior of the eye, all taken at a slightly different angle, and produces a three-dimensional representation of the interior of the eye on the computer monitor screen. Software facilities are included for a number of types of image manipulation, such as slicing, changing perspective or line, and measurement of distances, areas, and volumes.
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K Number
K971679Device Name
I-SCOPE OPHTHALMIC ENDOSCOPE
Manufacturer
OPHTHALMIC TECHNOLOGIES, INC.
Date Cleared
1997-06-25
(49 days)
Product Code
MPA
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
OPHTHALMIC TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ophthalmic Technologies i-Scope™ is intended to be used for visualization of intra-ocular structures, as a means to introduce micro instruments into the eye, or as a means to introduce laser fibers into the eye for photocoagulation.
Device Description
The Ophthalmic Technologies i-Scope™ is a rigid ophthalmic fiber-optic microendoscope. The i-Scope has an imaging fiber bundle with 10,000 pixels, an illumination fiber, and a working channel for an optional laser fiber or microinstruments. The laser fiber is disposable and can be replaced between cases. The fiber is not manufactured by Ophthalmic Technologies. The image fiber bundle terminal is connected to an orientation ring, video adapter and video camera. The illuminating bundle fiber can be connected to the OTI "XE-LITE" Xenon Light Source, or other light sources which have been cleared by the FDA. The laser fiber is disposable and can be replaced between cases.
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K Number
K960622Device Name
I-SCAN
Manufacturer
OPHTHALMIC TECHNOLOGIES, INC.
Date Cleared
1996-05-13
(90 days)
Product Code
IYO
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
OPHTHALMIC TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OTI i+tech "i-scan" ultrasound system is intended to both visualize the interior of the eye by means of ultrasound and to make measurements inside the eye, including the measurement of axial length for determination of IOL power.
Device Description
The OTI i+tech "i-scan" ultrasound system is a multipurpose personal-computer-based ultrasonic diagnosis system for ophthalmic applications. It includes three separate transducers which provide: 1. A Biometry X-mode for measurement of axial length, using a focused probe which can be hand-held or placed in a tonometer-holder. The operator has a choice of automatic measurement (in which the system automatically finds the critical structures in the eye and makes the measurements) or manual (in which the A-scan is presented on screen and the operator selects the points for a the measurements). 2. An A-scan mode for observation and measurement of the internal structures in the eye, with its own handheld probe. 3. A B-scan mode, usinç a hand-held motor-driven transducer, permitting visualization of internal structures in the eye. In X-mode, the system also performs IOL calculations with a choice of several algorithms.
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