510(k) · Cleared
ClearedGammaloc System, Model 03-00001
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dilon Technologies, LLC · IYX Camera, Scintillation (Gamma)
Cleared on Dec 11, 2009 as substantially equivalent to K984466 (Dilon Technologies, Inc., 1999) after a 459-day review. Its family tree reaches back 2 generations to 1993. 1 later device descends from it.
- Decided
- Dec 11, 2009
- Review
- 459 days
- Class
- Class I
- Product code
- IYX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K924639 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK924639 New Detector for Transcam/Polaris S315Adac Laboratories · 1993
- 1 generation backK984466 Dilon 2000, Model 2000-6X8 and Dilon 2000, Model 2000-5X5Dilon Technologies, Inc. · 1999
- This deviceK082588 Gammaloc System, Model 03-00001Dilon Technologies, LLC · 2009
- Descendant · cites it directly · 0 of its ownK160933 Discovery NM 750b BopsyGE Healthcare · 2016
Most influential descendants
Showing 1 of 1 · See all- K160933Discovery NM 750b BopsyGE Healthcare · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K924639 | New Detector for Transcam/Polaris S315 | Adac Laboratories | 1993 | — |
| −1 | K984466 | Dilon 2000, Model 2000-6X8 and Dilon 2000, Model 2000-5X5 | Dilon Technologies, Inc. | 1999 | — |
| 0 (this device) | K082588 | Gammaloc System, Model 03-00001 | Dilon Technologies, LLC | 2009 | — |
| +1 | K160933 | Discovery NM 750b Bopsy | GE Healthcare | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K984466 | Dilon 2000, Model 2000-6X8 and Dilon 2000, Model 2000-5X5Summary page 1…CFR 892.1100, Radiology Panel, IYX Device Descnption‘ The GammaLdc® System is a lesion localization accessory to the Dilon 6800 Gamma Camera, previously cleared under K984466 (originally named Dilon 2000 Digital Gamma Camera). The Dilon Gamma Camera is a high resolution, small field of view, portable ga… | 1999 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160933 | Discovery NM 750b Bopsy | 2016 | 0 |
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 16 years and passes through 3 companies; a new generation was cleared every 10.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K160933 (GE Healthcare, 2016) has gone furthest, with 0 descendants of its own.
- 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. 2009, 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 GammaLoc® System is a lesion localization accessory for the Dilon 6800 Gamma Camera. This stereotactic localization system gives the physician the capability to perform needle biopsy of lesions determined to be suspicious through gamma imaging.
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/K082588 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082588: Gammaloc System, Model 03-00001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082588
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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