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510(k) Data Aggregation
K Number
K972019Device Name
PEFECT SHOT
Manufacturer
Date Cleared
1997-07-03
(32 days)
Product Code
Regulation Number
872.6640Why did this record match?
Applicant Name (Manufacturer) :
INTERNATIONAL IMAGING ELECTRONICS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Perfect Shot Intra-Oral Camera is to be used by medical practitioners, usually dental hygienists, assistants or dentlats, to view the mouth of patients. It can explore the entire mouth and examine teeth or gum tissue for diagnostic purposes. It is distributed through dealers to medical practitioners.
The Perfect Shot is wireless, unlike other similar devices, allowing more freedom of movement by the user. It also contains voice activated instructions which enable the user to "freeze" a view on the monitor or take a picture and print) of the area being examined for reference at a later date by simply using voice instructions.
The product is designed to transmit a RF (radio frequency) signal to a receiver. This product can and will be used both intra and extra orally, which will allow a dentist to examine and display to the patient problem areas of concern or treatment that is required. The resolution capabilities of the CCD (Charge Coupled Device) is 640-480 lines.
The picture is transmitted to a monitor in the examination area for the patient to view , allowing the patient a better understanding of a potential problem and a better explanation of the prescribed solution.
Pictures that are captured may be printed for further review or for patient files. The Perfect Shot may also be attached to computers for digital storage or transmission to other computers.
Device Description
The Perfect Shot Intra-Oral Camera is a wireless intra-oral camera that transmits an RF signal to a receiver. It has voice activated instructions to freeze a view or take a picture. It uses a CCD with 640-480 lines resolution. The picture is transmitted to a monitor and can be printed or attached to computers for digital storage or transmission.
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K Number
K970964Device Name
MAESTRO DIGITAL IMAGE AND PATIENT RECORD STORAGE SYSTEM
Manufacturer
Date Cleared
1997-06-13
(88 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
INTERNATIONAL IMAGING ELECTRONICS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This device is intended to be used by all medical and dental personnel to store all patient medical or dental records on CD, Digital Audio Tapes or any future digital archivable media. The Maestro product is capable of transmitting patient records or claims to third party administrators or insurance companies for processing of patient insurance claims. Maestro allows a user to use digital zoom-in features to enlarge an x-ray film/images, or any type of document for closer examination.
Device Description
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K Number
K950330Device Name
DIGITAL IMAGE ACQUISITION SYSTEM
Manufacturer
Date Cleared
1996-05-07
(466 days)
Product Code
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
INTERNATIONAL IMAGING ELECTRONICS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K953165Device Name
ULTRA COMPACT VIDEO IMAGER
Manufacturer
Date Cleared
1996-05-07
(305 days)
Product Code
Regulation Number
892.2040Why did this record match?
Applicant Name (Manufacturer) :
INTERNATIONAL IMAGING ELECTRONICS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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