# K013176: Modification to: Sens-a-Ray System with Proimage Software

- Pathway: 510(k) (Special)
- Applicant: Afp Imaging Corp.
- Decided: Oct 16, 2001 after 22 days
- Product code: EHD (Unit, X-Ray, Extraoral With Timer)
- 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 K923067 (1992). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923067: Sens-a-Ray, Regam Medical Systems (1992) Summary page 1.

## Indications for use
The AFP Imaging Sens-A-Ray Digital Dental X-Ray System with Prolmage Software is intended for use with standard digital dental X-ray systems and computer stations for system operation, archive data storage, image capture and enhancement, and patient data and support.

Source page: https://510kreport.com/device/K013176
Methodology: https://510kreport.com/methodology