# K955643: Alara Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Denoptix, Inc.
- Decided: Mar 1, 1996 after 80 days
- Product code: EGY (Processor, Radiographic-Film, Automatic, Dental)
- Device class: 2
- Regulation: 21 CFR 892.1900
- 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 K884621 (1989). 5 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 10 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.
- K924459: Digiscan 2, Siemens Medical Solutions USA, Inc. (1992) Summary page 1.
- K884621: Digiscan, Siemens Medical Solutions USA, Inc. (1989) Summary page 1.
- K924012: Fuji Computed Radiography HI-C653 DMS CRT Image, Fujifilm Medical System U.S.A., Inc. (1992) Summary page 1.
- K923990: Fuji Computed Radiography HI-C652B DMS CRT Image, Fujifilm Medical System U.S.A., Inc. (1992) Summary page 1.

## Most influential descendants
- K071682: Crystalview T-Series Computed Radiography System, Models T110 (with Eraser) and T100 (Without Eraser) (2007), 1 descendant of its own
- K974619: Scanaray/CD-Dent Advanced Computerized X-Ray System (1998), 1 descendant of its own
- K102479: Alara T210 Computed Radiography System (2011), 0 descendants of its own
- 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 ALARA Imaging System is indicated for use digital dental radiography system for using X-ray recording media (phosphor storage screens) for radiographic diagnostic intraoral and extraoral exposures providing interactive CRT retrieval, viewing and processing of stored computed radiographic images.

Source page: https://510kreport.com/device/K955643
Methodology: https://510kreport.com/methodology