# K110384: Dilon 6800 Acella (Acella)

- Pathway: 510(k) (Traditional)
- Applicant: Dilon Technologies, Inc.
- Decided: May 3, 2011 after 82 days
- Product code: IYX (Camera, Scintillation (Gamma))
- Device class: 1
- Regulation: 21 CFR 892.1100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K885054 (1989). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984466: Dilon 2000, Model 2000-6X8 and Dilon 2000, Model 2000-5X5, Dilon Technologies, Inc. (1999) Summary page 1.
- K100838: Ergo Imaging System, Digirad Corp. (2010) Summary page 1.

## Indications for use
The Dilon 6800 Acella Digital Gamma Camera is intended to be used to measure and image the distribution of selected single photon emitting radioisotopes in the human body. The resulting images are intended to be reviewed by qualified medical personnel.

Source page: https://510kreport.com/device/K110384
Methodology: https://510kreport.com/methodology