# K041385: Modification to Computed Oral Radiology System

- Pathway: 510(k) (Special)
- Applicant: Schick Technologies, Inc.
- Decided: Jun 7, 2004 after 13 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: 1 generation back to K933455 (1994). 1 ancestor in all.
61 later devices descend from it; 3 cite it directly.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933455: Computed Oral Radiology System, Schick Technologies, Inc. (1994) Summary page 1.

## Most influential descendants
- K072134: Schick Computed Oral Radiology System (2007), 59 descendants of its own
- K090526: Medical Image Processing Unit, Model Ezsensor (2009), 18 descendants of its own
- K090458: Dexis Sensor (2009), 18 descendants of its own
- K103290: Edlen Imaging - Gemini Dusb (2011), 13 descendants of its own
- K150823: EDLENi Intra-Oral Sensor (2015), 11 descendants of its own

## Indications for use
The Computed Oral Radiology System is indicated for patients undergoing an intra-oral dental x-ray examination. It produces instant, digital, intra-oral x-ray images of a patient’s mouth while reducing the necessary x-ray dosage.

Source page: https://510kreport.com/device/K041385
Methodology: https://510kreport.com/methodology