# K131442: Firecr Dentalimaging System

- Pathway: 510(k) (Traditional)
- Applicant: 3Disc Americas
- Decided: Sep 6, 2013 after 109 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: 2 generations back to K934949 (1994). 2 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041050: Digora Optime (or Digora Ontime), Soredex Palodex Group OY (2004) Summary page 1.

## Most influential descendants
- K160788: RIOScan (RPS500) (2016), 6 descendants of its own
- K170733: ScanX Intraoral View (2017), 5 descendants of its own
- K212080: Imaging Plate Scanner, i-Scan (2021), 1 descendant of its own
- K202633: ScanX Edge (2020), 1 descendant of its own
- K143703: NICAL SMART MICRO CR system for intraoral dental images (2015), 1 descendant of its own

## Indications for use
The FireCR Dental Imaging System is indicated for capturing, digitization and processing of intra-oral x-ray images stored in imaging plate recording media.

Source page: https://510kreport.com/device/K131442
Methodology: https://510kreport.com/methodology