510(k) · Cleared
ClearedLumagem Molecular Breast Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gamma Medica-Ideas Incorporated · IYX Camera, Scintillation (Gamma)
Cleared on Sep 23, 2011 as substantially equivalent to K993813 (Gamma Medica, 2000) and 1 other predicate after an 88-day review. Its family tree reaches back 5 generations to 1995. 3 of the 13 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Sep 23, 2011
- Review
- 88 days
- Class
- Class I
- Product code
- IYX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K952674 (1995). 11 ancestors in all, the oldest K885054 (1989). 1 later device descends from it, 1 citing it directly. 3 of the 13 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK952674 Transact: Attenuation Correction System for the Apex Cardial Gamma…Elscint, Inc. · 1995 · Recalled
- 4 generations backK980959 Vtransact: Attenuation Correction System for Dual-Head Variable…Ge Medical Systems F.I. Haifa · 1998
- 3 generations backK991841 Hawkeye Option for Dual-Head Variable Angle Gamma CameraGe Medical Systems F.I. Haifa · 1999 · Recalled (Class I)
- 2 generations backK022960 GE Quasar Nuclear Medicine SystemGe Medical Systems F.I. Haifa · 2002 · Recalled (Class I)
- 1 generation backK102231 Discovery NM 750BGe Medical Systems Israel, Functional Imaging · 2010
- This deviceK111791 Lumagem Molecular Breast Imaging SystemGamma Medica-Ideas Incorporated · 2011
- Descendant · cites it directly · 0 of its ownK123408 Ergo Imaging SystemDigirad Corp. · 2013
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K123408Ergo Imaging SystemDigirad Corp. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K952674 | Transact: Attenuation Correction System for the Apex Cardial Gamma Camera | Elscint, Inc. | 1995 | 1 |
| −4 | K980959 | Vtransact: Attenuation Correction System for Dual-Head Variable Angle Gamma… | Ge Medical Systems F.I. Haifa | 1998 | — |
| −3 | K991841 | Hawkeye Option for Dual-Head Variable Angle Gamma Camera | Ge Medical Systems F.I. Haifa | 1999 | Class I |
| −2 | K022960 | GE Quasar Nuclear Medicine System | Ge Medical Systems F.I. Haifa | 2002 | Class I |
| −1 | K102231 | Discovery NM 750B | Ge Medical Systems Israel, Functional Imaging | 2010 | — |
| 0 (this device) | K111791 | Lumagem Molecular Breast Imaging System | Gamma Medica-Ideas Incorporated | 2011 | — |
| +1 | K123408 | Ergo Imaging System | Digirad Corp. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 1 |
| 1997 | 2 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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.
3 devices in this family have a Class I recall. 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 |
|---|---|---|---|
| * | K993813 | Lumagem Scintillation CameraSummary page 1…ame: LumaGEMr Molecular Breast Imaging System Generic/Common Name: Scintillation (gamma) camera PREDICATE DEVICES Gamma Medica. LumaGEMT M Scintillation Camera (K9938 13). GE Healthcare Discovery NM 750b Gamma Camera (K1 0223 1)… | 2000 |
| * | K102231 | Discovery NM 750BSummary page 1…c/Common Name: Scintillation (gamma) camera PREDICATE DEVICES Gamma Medica. LumaGEMT M Scintillation Camera (K9938 13). GE Healthcare Discovery NM 750b Gamma Camera (K1 0223 1) 22 GAMMA MEDICA-IDEAS,… | 2010 |
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 |
|---|---|---|---|
| K123408 | Ergo Imaging System | 2013 | 0 |
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K022960GE Quasar Nuclear Medicine SystemGe Medical Systems F.I. Haifa · 2002 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K991841Hawkeye Option for Dual-Head Variable Angle Gamma CameraGe Medical Systems F.I. Haifa · 1999 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K953801VaricamElscint, Inc. · 1995 · 3 generations back · ◆ in the 1995 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- 4 of the 11 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K123408 (Digirad Corp., 2013) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K993813.
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 LumaGEM Molecular Breast Imaging System is intended to measure and image the distribution of radionuclides by means of photon detection in order to aid in the evaluation of lesions in the breast tissue and other small body parts. The LumaGEM TM Molecular Breast Imaging System, when used for breast imaging, is intended to serve as an adjunct to mammography or other primary breast imaging modalities. The LumaGEM Molecular Breast Imaging System is indicated for planar scintigraphy in the energy range of 30-300 key for the detection and display of radioisotope tracer uptake in patients of all ages. The resultant images are intended to be viewed by qualified medical professionals.
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/K111791 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111791: Lumagem Molecular Breast Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111791
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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