510(k) · Cleared
ClearedLumagem Scintillation Camera
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gamma Medica · IYX Camera, Scintillation (Gamma)
Cleared on Jan 18, 2000 as substantially equivalent to K921296 (Adac Laboratories, 1992) and 2 other predicates after a 69-day review. Its family tree reaches back 2 generations to 1989. 5 later devices descend from it.
- Decided
- Jan 18, 2000
- Review
- 69 days
- Class
- Class I
- Product code
- IYX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K885054 (1989). 3 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK885054 System Seventy SevenScinticor, Inc. · 1989
- 1 generation backK961104 Notebook ImagerDigirad Corp. · 1997
- This deviceK993813 Lumagem Scintillation CameraGamma Medica · 2000
- Descendant · cites it directly · 3 of its ownK102231 Discovery NM 750BGe Medical Systems Israel, Functional Imaging · 2010
- Descendant · cites it directly · 1 of its ownK111791 Lumagem Molecular Breast Imaging SystemGamma Medica-Ideas Incorporated · 2011
- Descendant · 2 generations on · 0 of its ownK160933 Discovery NM 750b BopsyGE Healthcare · 2016
- Descendant · 2 generations on · 0 of its ownK123408 Ergo Imaging SystemDigirad Corp. · 2013
- Descendant · cites it directly · 0 of its ownK092471 Model Sentinella 102General Equipment For Medical Imaging, S.A. · 2009
Most influential descendants
Showing 5 of 5 · See all- K102231Discovery NM 750BGe Medical Systems Israel, Functional Imaging · 2010 · cites it directly3descendants
- K111791Lumagem Molecular Breast Imaging SystemGamma Medica-Ideas Incorporated · 2011 · cites it directly1descendant
- K160933Discovery NM 750b BopsyGE Healthcare · 2016 · 2 generations on0descendants
- K123408Ergo Imaging SystemDigirad Corp. · 2013 · 2 generations on0descendants
- K092471Model Sentinella 102General Equipment For Medical Imaging, S.A. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K885054 | System Seventy Seven | Scinticor, Inc. | 1989 | — |
| −1 | K961104 | Notebook Imager | Digirad Corp. | 1997 | — |
| 0 (this device) | K993813 | Lumagem Scintillation Camera | Gamma Medica | 2000 | — |
| +1 | K102231 | Discovery NM 750B | Ge Medical Systems Israel, Functional Imaging | 2010 | — |
| +1 | K111791 | Lumagem Molecular Breast Imaging System | Gamma Medica-Ideas Incorporated | 2011 | — |
| +2 | K160933 | Discovery NM 750b Bopsy | GE Healthcare | 2016 | — |
| +2 | K123408 | Ergo Imaging System | Digirad Corp. | 2013 | — |
| +1 | K092471 | Model Sentinella 102 | General Equipment For Medical Imaging, S.A. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 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? (5)
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 |
|---|---|---|---|
| * | K921296 | ADAC S315Summary page 2…e intended use, uses the same principle of radiation detection, and has very similar performance characteristics as the predicate devices; the the ADAC S$315 (Transcam), K921296, the Elscint APEX SPX-4, the DIGIRAD Notebook Imager K961104, the Siemens Orbiter and the SCINTICOR System Seventy Five (SIM-400)… | 1992 |
| * | K961104 | Notebook ImagerSummary page 2…n, and has very similar performance characteristics as the predicate devices; the the ADAC S$315 (Transcam), K921296, the Elscint APEX SPX-4, the DIGIRAD Notebook Imager K961104, the Siemens Orbiter and the SCINTICOR System Seventy Five (SIM-400), K885054. The main difference is that the LumaGEM™ camera us… | 1997 |
| * | K885054 | System Seventy SevenSummary page 2…the the ADAC S$315 (Transcam), K921296, the Elscint APEX SPX-4, the DIGIRAD Notebook Imager K961104, the Siemens Orbiter and the SCINTICOR System Seventy Five (SIM-400), K885054. The main difference is that the LumaGEM™ camera uses position sensitive photomultiplier tubes, which eliminate a substantial par… | 1989 |
| * | — | Elscint APEX SPX-4 Named without a submission number | |
| * | — | Siemens Orbiter Named without a submission number |
What descends from it? (5)
3 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?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 8.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K102231 (Ge Medical Systems Israel, Functional Imaging, 2010) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K921296.
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?
The LumaGEM™ scintillation camera is a gamma camera system, which is intended for measuring and imaging the distribution of radionuclides in the human body by means of photon detection. These images are intended to be interpreted 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/K993813 · printed Nov 5, 2026
Cite this page
510(k) Report. “K993813: Lumagem Scintillation Camera.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K993813
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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