Search Results
Found 1 results
510(k) Data Aggregation
K Number
K040691Device Name
INTRA ORAL CAMERA SYSTEM & ACCESSORIES, MODEL WIN-100D
Manufacturer
Date Cleared
2004-03-23
(6 days)
Product Code
Regulation Number
872.6640Why did this record match?
Applicant Name (Manufacturer) :
WIN-US TECHNOLOGY CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Win-100D intra oral camera system and accessories is indicated for use to provide the dentist and the patient with a view of the mouth before and after the dental procedure, which assists the dentist in describing the dental procedure being performed as well as showing the results.
Device Description
Our device comprises of a light (0.6Kg), small (230mmX12mm), compact design and ergonomic handpiece along with a multi-docking system. The handpiece consists of a focusing mechanism and a capture button to assist the capture intraoral or full face images of the patient. The handpiece connects to a multi-docking system via a cable. The multi-docking system in turn can connect directly to a monitor and PC via a standard composite connection (RCA). It uses high definition imaging (460 TV-lines) to capture images at 80 degrees field of view. It can make the screen in 4 frames or full screen mode via a multi-docking system. It can change the side of the captured image.
Ask a Question
Ask a specific question about this device
Page 1 of 1