# K974619: Scanaray/CD-Dent Advanced Computerized X-Ray System

- Pathway: 510(k) (Traditional)
- Applicant: Afp Imaging Corp.
- Decided: Feb 25, 1998 after 76 days
- Product code: LMA (Digitizer, Image, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2030
- 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 K884621 (1989). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934949: Digora, Orion Corporation Soredex (1994) Summary page 1.
- K955643: Alara Imaging System, Denoptix, Inc. (1996) Summary page 1.

## Most influential descendants
- K990049: CD-Dent Digital Imaging Devices for Dental X-Ray Systems, Models 600, 1000 and 2000 (1999), 0 descendants of its own

## Indications for use
The ScanARay Advanced Computerized X-Ray System is intended for digital dental radiography using a phosphor storage screen for radiographic diagnostic intraoral and extraoral exposures.

Source page: https://510kreport.com/device/K974619
Methodology: https://510kreport.com/methodology