510(k) · Cleared
ClearedMini Gamma Camera, Model MGC-500
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acrorad Co., Ltd. · IYX Camera, Scintillation (Gamma)
Cleared on May 14, 2004 as substantially equivalent to K961104 (Digirad Corp., 1997) after a 70-day review. Its family tree reaches back 2 generations to 1989. 1 later device descends from it.
- Decided
- May 14, 2004
- Review
- 70 days
- Class
- Class I
- Product code
- IYX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K885054 (1989). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK885054 System Seventy SevenScinticor, Inc. · 1989
- 1 generation backK961104 Notebook ImagerDigirad Corp. · 1997
- This deviceK040587 Mini Gamma Camera, Model MGC-500Acrorad Co., Ltd. · 2004
- Descendant · cites it directly · 0 of its ownK043293 Mini-Gamma Camera, Models MGC500-101U and MGC500-301UAcrorad Co., Ltd. · 2004
Most influential descendants
Showing 1 of 1 · See all- K043293Mini-Gamma Camera, Models MGC500-101U and MGC500-301UAcrorad Co., Ltd. · 2004 · 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) | K040587 | Mini Gamma Camera, Model MGC-500 | Acrorad Co., Ltd. | 2004 | — |
| +1 | K043293 | Mini-Gamma Camera, Models MGC500-101U and MGC500-301U | Acrorad Co., Ltd. | 2004 | — |
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 |
|---|---|---|
| 2004 | 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K961104 | Notebook ImagerSummary page 1…. LEGALLY MARKETED PREDICATE DEVICE The MGC-500 is substantially equivalent to the Digirad 2020 Notebook Imager, which was cleared by FDA on May 28, 1997 as K961 104. For the characteristic of intraoperative use, the MGC-500 is also substantially equivalent to the Neoprobe 1500/2000 r… | 1997 |
| Kept off the family tree | K971320 | FDA’s K971320 is Cre Balloon Dilatation Catheter Our reading of the summary gave K971320, FDA’s number for Cre Balloon Dilatation Catheter (Boston Scientific Corp). Its FDA name has none of the distinctive words the summary uses for the device it names, “Neoprobe 1500/2000 radioisotope detector”. Kept off the family tree. Summary page 1…7 as K961 104. For the characteristic of intraoperative use, the MGC-500 is also substantially equivalent to the Neoprobe 1500/2000 radioisotope detector (K971320). B. DEVICE DESCRIPTION The Mini Gamma Camera, MGC500, is a nuclear medical imager (commonly known as a scintillati… | 1997 |
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 |
|---|---|---|---|
| K043293 | Mini-Gamma Camera, Models MGC500-101U and MGC500-301U | 2004 | 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 15 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, K043293 (Acrorad Co., Ltd., 2004) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K961104.
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 Mini Gamma Camera MGC-500 is indicated for use in imaging the distribution of radionuclides in the human body using planer imaging techniques. The MGC-500 may also be used intraoperatively if a protective sheath is used.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040587 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040587: Mini Gamma Camera, Model MGC-500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040587
Report an extraction error
Are you the manufacturer?
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