# K113360: Medical Image Processing Unit

- Pathway: 510(k) (Special)
- Applicant: Humanray Co,Ltd
- Decided: Feb 7, 2012 after 85 days
- Product code: EAP (Unit, X-Ray, Intraoral)
- Device class: 2
- Regulation: 21 CFR 872.1810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K933455 (1994). 5 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090526: Medical Image Processing Unit, Model Ezsensor, E-Woo Technology (2009) Summary page 2.

## Most influential descendants
- K121132: Ezsensor P Digital Intraoral Sensor (2012), 4 descendants of its own
- K143000: RIS500 (2015), 2 descendants of its own
- K201247: Intraoral Sensor (2020), 0 descendants of its own
- K153710: Tuxedo Digital Dental Sensor (2016), 0 descendants of its own
- K140060: Digital Dental Intra Oral Sensor, Hdi 2000, Hdi 2000A (2014), 0 descendants of its own

## Indications for use
EzSensor T, Intra-oral Imaging System, is intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed, and manipulated for diagnostic use by dentists.

Source page: https://510kreport.com/device/K113360
Methodology: https://510kreport.com/methodology