510(k) · Cleared
ClearedCardiarc Spect Imaging Device, Model CQ103-RV2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiarc, Ltd. · KPS System, Tomography, Computed, Emission
Cleared on Jan 6, 2006 as substantially equivalent to K982855 (Digirad Corp., 1998) and 2 other predicates after a 67-day review. Its family tree reaches back 2 generations to 1991. 16 later devices descend from it.
- Decided
- Jan 6, 2006
- Review
- 67 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K914350 (1991). 7 ancestors in all, the oldest K885054 (1989). 16 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK914350 Icon Computer SystemSiemens Gammasonics, Inc. · 1991 · Recalled
- 1 generation backK972886 MirageSegami Corp., Inc. · 1997
- This deviceK053062 Cardiarc Spect Imaging Device, Model CQ103-RV2Cardiarc, Ltd. · 2006
- Descendant · cites it directly · 14 of its ownK062450 D-Spect Cardiac Scanner SystemSpectrum Dynamics, Ltd. · 2006
- Descendant · 2 generations on · 10 of its ownK072468 Modification to D-Spect Cardiac Scanner SystemSpectrum Dynamics, Ltd. · 2007 · Recalled
- Descendant · 3 generations on · 9 of its ownK110507 Cardiac Scanner and Processing SystemSpectrum Dynamics (Israel), Ltd. · 2011
- Descendant · 4 generations on · 5 of its ownK161740 D-SPECT Scanner, D-SPECT L ScannerSpectrum Dynamics Medical, Ltd. · 2016
- Descendant · 5 generations on · 4 of its ownK180514 Veriton NMSpectrum Dynamics Medical, Ltd. · 2018
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K062450D-Spect Cardiac Scanner SystemSpectrum Dynamics, Ltd. · 2006 · cites it directly14descendants
- K072468Modification to D-Spect Cardiac Scanner SystemSpectrum Dynamics, Ltd. · 2007 · 2 generations on10descendants
- K110507Cardiac Scanner and Processing SystemSpectrum Dynamics (Israel), Ltd. · 2011 · 3 generations on9descendants
- K161740D-SPECT Scanner, D-SPECT L ScannerSpectrum Dynamics Medical, Ltd. · 2016 · 4 generations on5descendants
- K180514Veriton NMSpectrum Dynamics Medical, Ltd. · 2018 · 5 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K914350 | Icon Computer System | Siemens Gammasonics, Inc. | 1991 | 1 |
| −1 | K972886 | Mirage | Segami Corp., Inc. | 1997 | — |
| 0 (this device) | K053062 | Cardiarc Spect Imaging Device, Model CQ103-RV2 | Cardiarc, Ltd. | 2006 | — |
| +1 | K062450 | D-Spect Cardiac Scanner System | Spectrum Dynamics, Ltd. | 2006 | — |
| +2 | K072468 | Modification to D-Spect Cardiac Scanner System | Spectrum Dynamics, Ltd. | 2007 | 1 |
| +3 | K110507 | Cardiac Scanner and Processing System | Spectrum Dynamics (Israel), Ltd. | 2011 | — |
| +4 | K161740 | D-SPECT Scanner, D-SPECT L Scanner | Spectrum Dynamics Medical, Ltd. | 2016 | — |
| +5 | K180514 | Veriton NM | Spectrum Dynamics Medical, Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2011 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (3)
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 |
|---|---|---|---|
| * | K982855 | Digirad 2020TC Spect Imaging SystemSummary page 1…SPECT Camera System CLASSIFICATION NAME: Computed Emission Tomography System PREDICATE DEVICES: DIGIRAD 2020tc SPECT inaging System (K982855) Segami Corporation Inc.'s Mirage software package (K972886 and K010726) INTENDED USE / INDICATIONS FOR USE:… | 1998 |
| * | K972886 | MirageSummary page 1…d Emission Tomography System PREDICATE DEVICES: DIGIRAD 2020tc SPECT inaging System (K982855) Segami Corporation Inc.'s Mirage software package (K972886 and K010726) INTENDED USE / INDICATIONS FOR USE: The CARDIARC SPECT IMAGING DEVICE and its predicate device is… | 1997 |
| * | K010726 | Modification to MirageSummary page 1…omography System PREDICATE DEVICES: DIGIRAD 2020tc SPECT inaging System (K982855) Segami Corporation Inc.'s Mirage software package (K972886 and K010726) INTENDED USE / INDICATIONS FOR USE: The CARDIARC SPECT IMAGING DEVICE and its predicate device is intend… | 2001 |
What descends from it? (16)
See all 162 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?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 8.3 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K062450 (Spectrum Dynamics, Ltd., 2006) has gone furthest, with 14 descendants of its own.
- 6 other devices also cite its predicate K982855.
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 CARDIARC SPECT IMAGING DEVICE is intended for production of single photon emission computed tomography clinical images of the heart in nuclear medicine applications. CARDIARC SPECT IMAGING DEVICE produces images from the distribution of radioisotopes within the thorax, which are then interpreted by healthcare professionals to assess various anatomical structures and functions (e.g., blood flow to the heart).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053062 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053062: Cardiarc Spect Imaging Device, Model CQ103-RV2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053062
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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