510(k) · Cleared
ClearedMini-Gamma Camera, Models MGC500-101U and MGC500-301U
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acrorad Co., Ltd. · KPS System, Tomography, Computed, Emission
Cleared on Dec 17, 2004 as substantially equivalent to K040587 (Acrorad Co., Ltd., 2004) after an 18-day review. Its family tree reaches back 3 generations to 1989.
- Decided
- Dec 17, 2004
- Review
- 18 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K885054 (1989). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK885054 System Seventy SevenScinticor, Inc. · 1989
- 2 generations backK961104 Notebook ImagerDigirad Corp. · 1997
- 1 generation backK040587 Mini Gamma Camera, Model MGC-500Acrorad Co., Ltd. · 2004
- This deviceK043293 Mini-Gamma Camera, Models MGC500-101U and MGC500-301UAcrorad Co., Ltd. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K885054 | System Seventy Seven | Scinticor, Inc. | 1989 | — |
| −2 | K961104 | Notebook Imager | Digirad Corp. | 1997 | — |
| −1 | K040587 | Mini Gamma Camera, Model MGC-500 | Acrorad Co., Ltd. | 2004 | — |
| 0 (this device) | 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 |
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 KPS? 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 KPS device
- #1 K253564 uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI…score 18.7 · 17 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K040587 | Mini Gamma Camera, Model MGC-500Summary page 1…LEGALLY MARKETED PREDICATE DEVICE The Mini Gamma Camera Models MGC500-101U and MGC500-301U are substantially equivalent to the currently marketed MGC500 (K040587). B. DEVICE DESCRIPTION The Mini Gamma Camera MGC500-101U and MGC500-301U , are nuclear medical imagers (comm… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
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 7.0 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KPS
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KPS
65in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KPS
16in 2025
Class I (17 since 2007) Class II/III not classified
Adverse event reports per year · KPS
36in 2025
MAUDE reports naming product code KPS, 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 | 8 | 38 | 22 | 38 |
| 2008 | 17 | 25 | 16 | 11 |
| 2009 | 9 | 42 | 14 | 15 |
| 2010 | 3 | 91 | 4 | 44 |
| 2011 | 7 | 28 | 34 | 56 |
| 2012 | 6 | 94 | 13 | 34 |
| 2013 | 11 | 84 | 13 | 240 |
| 2014 | 11 | 92 | 18 | 33 |
| 2015 | 3 | 112 | 5 | 24 |
| 2016 | 11 | 65 | 16 | 10 |
| 2017 | 11 | 104 | 11 | 31 |
| 2018 | 13 | 59 | 12 (3) | 26 |
| 2019 | 3 | 60 | 5 (5) | 105 |
| 2020 | 12 | 72 | 8 | 22 |
| 2021 | 15 | 66 | 4 | 10 |
| 2022 | 5 | 60 | 8 (6) | 15 |
| 2023 | 12 | 63 | 6 (3) | 22 |
| 2024 | 11 | 59 | 15 | 23 |
| 2025 | 12 | 65 | 16 | 36 |
| 2026 | 6 | 67 | 6 | — |
What is it indicated for?
The Mini Gamma Camera MGC500-101U and MGC500-301U are indicated for use in imaging the distribution of radionuclides in the human body using planer imaging techniques. The MGC500-101U and MGC500-301U may also be used intraoperatively if a protective sheath is used.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043293 · printed Nov 3, 2026
Cite this page
510(k) Report. “K043293: Mini-Gamma Camera, Models MGC500-101U and MGC500-301U.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K043293
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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