# K051664: SCAN300FP / Retropan (VDC)

- Pathway: 510(k) (Traditional)
- Applicant: Oy Ajat, Ltd.
- Decided: Jul 20, 2005 after 28 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K060149: Sunipan Imaging System & Accessories (2006), 0 descendants of its own

## Indications for use
The Scan300fp / Recropan (VDOC Digital X-ray Conversion Kit is used to provide instant x-ray images of human oral tissue and teeth without the use of conventional x-ray films. The Scan300fp sensor produces instant digital images. The Scan300fp allows the use of less exposure time than with conventional films, thus lowering patient dose. The sensor is connected to the DentalEye software. #KO 12439, which gives post processing capabilities to enhance images. It is faster to obtain images with the Scan300fp / Retrofit (VDC] than with conventional film since no chemical nor any other type of processing is required.

Source page: https://510kreport.com/device/K051664
Methodology: https://510kreport.com/methodology