510(k) · Cleared
ClearedDilon 2000, Model 2000-6X8 and Dilon 2000, Model 2000-5X5
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 Mar 16, 1999 as substantially equivalent to K924639 (Adac Laboratories, 1993) after a 90-day review. Its family tree reaches back 1 generation to 1993. 3 later devices descend from it.
- Decided
- Mar 16, 1999
- Review
- 90 days
- Class
- Class I
- Product code
- IYX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K924639 (1993). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK924639 New Detector for Transcam/Polaris S315Adac Laboratories · 1993
- This deviceK984466 Dilon 2000, Model 2000-6X8 and Dilon 2000, Model 2000-5X5Dilon Technologies, Inc. · 1999
- Descendant · cites it directly · 1 of its ownK082588 Gammaloc System, Model 03-00001Dilon Technologies, LLC · 2009
- Descendant · 2 generations on · 0 of its ownK160933 Discovery NM 750b BopsyGE Healthcare · 2016
- Descendant · cites it directly · 0 of its ownK110384 Dilon 6800 Acella (Acella)Dilon Technologies, Inc. · 2011
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K924639 | New Detector for Transcam/Polaris S315 | Adac Laboratories | 1993 | — |
| 0 (this device) | K984466 | Dilon 2000, Model 2000-6X8 and Dilon 2000, Model 2000-5X5 | Dilon Technologies, Inc. | 1999 | — |
| +1 | K082588 | Gammaloc System, Model 03-00001 | Dilon Technologies, LLC | 2009 | — |
| +2 | K160933 | Discovery NM 750b Bopsy | GE Healthcare | 2016 | — |
| +1 | K110384 | Dilon 6800 Acella (Acella) | Dilon Technologies, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2016 | 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? (1)
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 |
|---|---|---|---|
| * | K924639 | New Detector for Transcam/Polaris S315Summary page 1…m Contact Person: Dilon 2000 Gamma Camera System Scintillation (Gamma) Camera Device Trade Name: Common Name: Classification Name: ADAC Transcam Predicate Devices: (K924639) Device Description: The Dilon 2000 is a high resolution, small field of view, portable gamma camera designed for general use i… | 1993 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Its one ancestor has no recall.
- Of its descendants, K082588 (Dilon Technologies, LLC, 2009) has gone furthest, with 1 descendant of its own.
How does its category compare?
All IYX devicesIYX Camera, Scintillation (Gamma): FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
To detect or image the distribution of radionuclides in the body or organ, using the following technique(s).
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/K984466 · printed Nov 6, 2026
Cite this page
510(k) Report. “K984466: Dilon 2000, Model 2000-6X8 and Dilon 2000, Model 2000-5X5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K984466
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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