510(k) · Cleared
ClearedMG Atc: Attenuation Correction System for Dual-Head Variable-Angle Gamma Camera
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems F.I. Haifa · KPS System, Tomography, Computed, Emission
Cleared on Aug 23, 1999 as substantially equivalent to K980959 (Ge Medical Systems F.I. Haifa, 1998) after an 81-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Aug 23, 1999
- Review
- 81 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K952674 (1995). No later device cites it as a predicate yet.
- Root · 2 generations backK952674 Transact: Attenuation Correction System for the Apex Cardial Gamma…Elscint, Inc. · 1995 · Recalled
- 1 generation backK980959 Vtransact: Attenuation Correction System for Dual-Head Variable…Ge Medical Systems F.I. Haifa · 1998
- This deviceK991896 MG Atc: Attenuation Correction System for Dual-Head Variable-Angle…Ge Medical Systems F.I. Haifa · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K952674 | Transact: Attenuation Correction System for the Apex Cardial Gamma Camera | Elscint, Inc. | 1995 | 1 |
| −1 | K980959 | Vtransact: Attenuation Correction System for Dual-Head Variable Angle Gamma… | Ge Medical Systems F.I. Haifa | 1998 | — |
| 0 (this device) | K991896 | MG Atc: Attenuation Correction System for Dual-Head Variable-Angle Gamma Camera | Ge Medical Systems F.I. Haifa | 1999 | — |
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 |
|---|---|---|---|
| * | K980959 | Vtransact: Attenuation Correction System for Dual-Head Variable Angle Gamma CameraSummary page 1…of legally marketed device. Identification of Legally Marketed Equivalent Devices V_TransACT: Attenuation Correction System for Dual-Head Variable-Angle Gamma Camera — K980959. Device Description The MG ATC attenuation correction system is an optional addition to the Millennium MG gamma camera (K962738… | 1998 |
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 4 years and passes through 2 companies; a new generation was cleared every 2.7 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 2 other devices also cite its predicate K980959.
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?
MG ATC is indicated to improve the quality of emission SPECT images obtained on the Millennium MG dual head camera by attenuation correction.
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/K991896 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991896: MG Atc: Attenuation Correction System for Dual-Head Variable-Angle Gamma Camera.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991896
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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