510(k) · Cleared
ClearedDilon 6800 Acella (Acella)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dilon Technologies, Inc. · IYX Camera, Scintillation (Gamma)
Cleared on May 3, 2011 as substantially equivalent to K984466 (Dilon Technologies, Inc., 1999) and 1 other predicate after an 82-day review. Its family tree reaches back 6 generations to 1989.
- Decided
- May 3, 2011
- Review
- 82 days
- Class
- Class I
- Product code
- IYX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K885054 (1989). 18 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK885054 System Seventy SevenScinticor, Inc. · 1989
- 5 generations backK982855 Digirad 2020TC Spect Imaging SystemDigirad Corp. · 1998
- 4 generations backK051549 Cardius-1, Cardius-2, Cardius-3, 2020TC Spect Imaging SystemDigirad Corp. · 2005
- 3 generations backK052430 Cardius-1, Cardius-2, Cardius-3, 2020TC Spect Imaging SystemDigirad Corp. · 2005
- 2 generations backK070542 Cardius 1, 2 and 3 Xpo and 2020TC Spect Imaging SystemsDigirad Corp. · 2007
- 1 generation backK100838 Ergo Imaging SystemDigirad Corp. · 2010
- This deviceK110384 Dilon 6800 Acella (Acella)Dilon Technologies, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K885054 | System Seventy Seven | Scinticor, Inc. | 1989 | — |
| −5 | K982855 | Digirad 2020TC Spect Imaging System | Digirad Corp. | 1998 | — |
| −4 | K051549 | Cardius-1, Cardius-2, Cardius-3, 2020TC Spect Imaging System | Digirad Corp. | 2005 | — |
| −3 | K052430 | Cardius-1, Cardius-2, Cardius-3, 2020TC Spect Imaging System | Digirad Corp. | 2005 | — |
| −2 | K070542 | Cardius 1, 2 and 3 Xpo and 2020TC Spect Imaging Systems | Digirad Corp. | 2007 | — |
| −1 | K100838 | Ergo Imaging System | Digirad Corp. | 2010 | — |
| 0 (this device) | K110384 | Dilon 6800 Acella (Acella) | Dilon Technologies, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IYX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new IYX device
- #1 K230221 QDOSE® Multi-purpose Voxel Dosimetry…score 6.2 · 2 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K984466 | Dilon 2000, Model 2000-6X8 and Dilon 2000, Model 2000-5X5Summary page 1…llation (gamma) PRO CODE: IYX SUBSTANTIALLY EQUIVALENT TO: —SPECIAL 510(k) Modifications to Dilon 2000 (now known as Dilon 6800, K984466 for a technology change. The primary difference isthechange indetector technology from photomultiplier tubes tothe photodi… | 1999 |
| * | K100838 | Ergo Imaging SystemSummary page 1…ology change. The primary difference isthechange indetector technology from photomultiplier tubes tothe photodiode technology, previously cleared by FDA in K100838. DilonTechnologies, Inc. has demonstrated that thereare no new safety issues due to the change indetector technology and h… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 18 ancestors has a recall of any class.
- 1 other device also cites its predicate K984466.
How does its category compare?
All IYX devicesIYX Camera, Scintillation (Gamma): FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · IYX
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · IYX
82in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYX
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYX
1in 2022
MAUDE reports naming product code IYX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 11 |
| 2008 | 2 | — | 0 | 10 |
| 2009 | 2 | — | 0 | 8 |
| 2010 | 4 | 82 | 0 | 5 |
| 2011 | 3 | 82 | 0 | 6 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 4 |
| 2016 | 2 | — | 0 | 2 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 2 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K110384 · printed Nov 3, 2026
Cite this page
510(k) Report. “K110384: Dilon 6800 Acella (Acella).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K110384
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026