# K062376: Direct Digital Radiography CCD Imaging Sensor, Naomi

- Pathway: 510(k) (Traditional)
- Applicant: Rf Systems Lab.
- Decided: Oct 27, 2006 after 73 days
- Product code: MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager))
- Device class: 2
- Regulation: 21 CFR 892.1680
- 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
- K111103: Digital X-Ray Imaging System (2012), 0 descendants of its own

## Indications for use
The Direct Digital Radiography CCD Imaging Sensor, NAOMI provides digital image capture for conventional film / screen radiographic examinations. The device is intended to replace radiographic film / screen systems in all general-purpose diagnostic procedures. "The device must not be used for primary diagnosis in mammography."

Source page: https://510kreport.com/device/K062376
Methodology: https://510kreport.com/methodology