# K992392: RTLX

- Pathway: 510(k) (Traditional)
- Applicant: Infimed, Inc.
- Decided: Mar 31, 2000 after 256 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
Longest line of descent: 1 generation back to K881133 (1989). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943532: Panoramic Corporation HDLX, Panoramic Corp. (1994) Summary page 2.
- K933455: Computed Oral Radiology System, Schick Technologies, Inc. (1994) Summary page 2.
- K881133: 70-X/RVG (Radiovisiography), Trophy Radiologie (1989) Summary page 2.

## Indications for use
The RTLX is a digital dental X-ray system with an intra-oral electronic sensor. Its intended use is to provide real-time x-ray images for dentists with a low X-ray dose By producing real-time imaging, the RTLX provides immediate information in the course of operative treatment, such as information on the position of instruments in internal structures.

Source page: https://510kreport.com/device/K992392
Methodology: https://510kreport.com/methodology