510(k) · Cleared
ClearedMulti-Spect
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eagle Heart Imaging, LLC · KPS System, Tomography, Computed, Emission
Cleared on Nov 6, 2007 as substantially equivalent to K790499 (Engineering Dynamics Corp., 1979) and 3 other predicates after an 11-day review. Its family tree reaches back 1 generation to 1979.
- Decided
- Nov 6, 2007
- Review
- 11 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K790499 (1979). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK790499 Multiple Pinhole Tomographic CollimoterEngineering Dynamics Corp. · 1979
- This deviceK073021 Multi-SpectEagle Heart Imaging, LLC · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K790499 | Multiple Pinhole Tomographic Collimoter | Engineering Dynamics Corp. | 1979 | — |
| 0 (this device) | K073021 | Multi-Spect | Eagle Heart Imaging, LLC | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1992 | 1 | 0 |
| 1999 | 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 18.6 · 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 |
|---|---|---|---|
| * | K790499 | Multiple Pinhole Tomographic CollimoterSummary page 1…FR 892.1200, Class II Product Code: 90 KPS C: Predicate Device(s): Multiple Pinhole Tomographic Collimator Engineering Dynamics Corp. (K790499); ADAC Tomography Option (K791055) This collimator was used as an add on accessory to single headed… | 1979 |
| * | K791055 | Adac Tomography OptionSummary page 1…: 90 KPS C: Predicate Device(s): Multiple Pinhole Tomographic Collimator Engineering Dynamics Corp. (K790499); ADAC Tomography Option (K791055) This collimator was used as an add on accessory to single headed gamma cameras such as the Picker Dyna… | 1979 |
| * | K922080 | Genesys IISummary page 1…gamma cameras such as the Picker Dynacamera 4/15, Ohio Sigma 410, or the Siemens LFOV. Vertex Dual Headed Gamma Camera ADAC Laboratories (K922080) The detectors from this camera are used with the new device. Cardiac images from this camera are of typi… | 1992 |
| * | K992317 | Autospect Plus with Instill Motion CorrectionSummary page 1…ed with the new device. Cardiac images from this camera are of typical quality for current SPECT cameras. AutoSPECT ADAC Laboratories (K992317) This software package reconstructs the views acquired by a SPECT system into a 3 dimensional array for dat… | 1999 |
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?
- 1 of the 4 ancestors has a recall of any class.
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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 Multi-SPECT is intended for use as an accessory to an dual headed nuclear medicine gamma camera (for example - the ADAC Vertex Dual Headed Nuclear Medicine Camera). It is to be used to perform static, dynamic and/or gated Single Photon Emission Computed Tomography clinical nuclear medicine images of the heart. It is indicated for use to produce images showing the location and distribution of radioisotopes in the human body for interpretation by a physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073021 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073021: Multi-Spect.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073021
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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