510(k) · Cleared
ClearedMCD-AC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Adac Laboratories · KPS System, Tomography, Computed, Emission
Cleared on Oct 23, 1997 as substantially equivalent to K952684 (Adac Laboratories, 1995) after a 147-day review. Its family tree reaches back 1 generation to 1995. 2 later devices descend from it.
- Decided
- Oct 23, 1997
- Review
- 147 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K952684 (1995). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK952684 Vertex Epic MCDAdac Laboratories · 1995 · Recalled
- This deviceK971980 MCD-ACAdac Laboratories · 1997
- Descendant · cites it directly · 0 of its ownK991565 Tac-2, Transmission Attenuation Correction and DST, DST-XL Gamma…Smv America · 1999
- Descendant · cites it directly · 0 of its ownK991535 Convergence CDR for Hitachi Spectradigital V250DSP Gamma CamerasHitachi Medical Corp. of America · 1999
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K952684 | Vertex Epic MCD | Adac Laboratories | 1995 | 2 |
| 0 (this device) | K971980 | MCD-AC | Adac Laboratories | 1997 | — |
| +1 | K991565 | Tac-2, Transmission Attenuation Correction and DST, DST-XL Gamma Cameras and… | Smv America | 1999 | — |
| +1 | K991535 | Convergence CDR for Hitachi Spectradigital V250DSP Gamma Cameras | Hitachi Medical Corp. of America | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 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 18.6 · 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? (4)
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 |
|---|---|---|---|
| * | K952684 | Vertex Epic MCDSummary page 1…on which can take 180° images). MCD-AC is short for Molecular Coincidence Defection Attenuation Correction, and is a modification to the EPIC-MCD system, cleared in 510k K952684. The MCD-AC uses the same principle of coincidence imaging used by the EPIC-MCD, but adds the image quality enhancing feature of… | 1995 |
| * | — | Vantage 1.0 Named without a submission number | |
| * | — | UGM 240H Named without a submission number | |
| * | — | GE Advance Named without a submission number |
What descends from it? (2)
2 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?
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?
ADAC MCD-AC option to ADAC Dual Head Emission Tomographic System produces images of biodistribution of positron-emitting radioisotopes previously administered to the human body. The system is intended to provide an enhancement to the emission images acquired using the ADAC MCD System by correcting for attenuation effects in the human body.
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/K971980 · printed Nov 5, 2026
Cite this page
510(k) Report. “K971980: MCD-AC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K971980
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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