# K070535: Retropan CCD-Twain-Usb

- Pathway: 510(k) (Traditional)
- Applicant: Video Dental Concepts, Inc.
- Decided: Apr 24, 2007 after 57 days
- Product code: MUH (System, X-Ray, Extraoral Source, Digital)
- Device class: 2
- Regulation: 21 CFR 872.1800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The RetroPan CCD - TWAIN - USB Digital X-ray Conversion Kit from Video Dental Concepts, Inc. is used to provide instant x-ray images of human oral tissue and teeth without the use of conventional x-ray films. The RetroPan CCD - TWAIN - USS sensor produces instant digital images. The RetroPan CCD - TWAIN - USB allows the use of less exposure time than with conventional films, thus lowering patient dose. The sensor is connected to the DentalEye software, #K-1 2439, which gives post processing capabilities to enhance images. It is faster to obtain images with the RetroPan CCD - TWAIN - USB Retrofit Kit than from conventional film since no chemical nor any other type of processing is required.

Source page: https://510kreport.com/device/K070535
Methodology: https://510kreport.com/methodology