510(k) · Cleared
ClearedADAC S315
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Adac Laboratories · IYX Camera, Scintillation (Gamma)
Cleared on May 28, 1992 after a 72-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 14 later devices descend from it.
- Decided
- May 28, 1992
- Review
- 72 days
- Class
- Class I
- Product code
- IYX
- Recalls
- None
- Predicates
- 0
14 later devices descend from it, 2 citing it directly.
- This deviceK921296 ADAC S315Adac Laboratories · 1992
- Descendant · cites it directly · 13 of its ownK961104 Notebook ImagerDigirad Corp. · 1997
- Descendant · cites it directly · 5 of its ownK993813 Lumagem Scintillation CameraGamma Medica · 2000
- Descendant · 2 generations on · 3 of its ownK102231 Discovery NM 750BGe Medical Systems Israel, Functional Imaging · 2010
- Descendant · 2 generations on · 3 of its ownK020643 EZ-Scope an & EZ-Scope an LiteHealth Policy Resorters Group, LLC · 2002
- Descendant · 2 generations on · 2 of its ownK100838 Ergo Imaging SystemDigirad Corp. · 2010
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K961104Notebook ImagerDigirad Corp. · 1997 · cites it directly13descendants
- K993813Lumagem Scintillation CameraGamma Medica · 2000 · cites it directly5descendants
- K102231Discovery NM 750BGe Medical Systems Israel, Functional Imaging · 2010 · 2 generations on3descendants
- K020643EZ-Scope an & EZ-Scope an LiteHealth Policy Resorters Group, LLC · 2002 · 2 generations on3descendants
- K100838Ergo Imaging SystemDigirad Corp. · 2010 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K921296 | ADAC S315 | Adac Laboratories | 1992 | — |
| +1 | K961104 | Notebook Imager | Digirad Corp. | 1997 | — |
| +1 | K993813 | Lumagem Scintillation Camera | Gamma Medica | 2000 | — |
| +2 | K102231 | Discovery NM 750B | Ge Medical Systems Israel, Functional Imaging | 2010 | — |
| +2 | K020643 | EZ-Scope an & EZ-Scope an Lite | Health Policy Resorters Group, LLC | 2002 | — |
| +2 | K100838 | Ergo Imaging System | Digirad Corp. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (14)
See all 142 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?
- Of its descendants, K961104 (Digirad Corp., 1997) has gone furthest, with 13 descendants 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 | — |
https://510kreport.com/device/K921296 · printed Nov 6, 2026
Cite this page
510(k) Report. “K921296: ADAC S315.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K921296
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026