510(k) · Cleared
ClearedDigirad 2020TC Spect Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Digirad Corp. · KPS System, Tomography, Computed, Emission
Cleared on Nov 4, 1998 as substantially equivalent to K885054 (Scinticor, Inc., 1989) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 1989. 1 of the 384 devices in its family, counting itself, has a Class I recall. 381 later devices descend from it.
- Decided
- Nov 4, 1998
- Review
- 90 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K885054 (1989). 2 ancestors in all. 381 later devices descend from it, 7 citing it directly. 1 of the 384 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK885054 System Seventy SevenScinticor, Inc. · 1989
- This deviceK982855 Digirad 2020TC Spect Imaging SystemDigirad Corp. · 1998
- Descendant · cites it directly · 354 of its ownK011572 Quantitative Gated Spect (QGS), Quantitative Perfusion Spect (QPS)Digirad Corp. · 2001
- Descendant · 2 generations on · 353 of its ownK052379 Mim 3.5 (Circa)Mimvista Corp. · 2005
- Descendant · 3 generations on · 350 of its ownK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- Descendant · 4 generations on · 287 of its ownK071964 Mim 4.1 (Seastar)Mimvista Corp. · 2007 · Recalled
- Descendant · 5 generations on · 200 of its ownK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
Showing 5 of 381 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…10 generations on · 2025
Most influential descendants
Showing 5 of 381 · See all- K011572Quantitative Gated Spect (QGS), Quantitative Perfusion Spect (QPS)Digirad Corp. · 2001 · cites it directly354descendants
- K052379Mim 3.5 (Circa)Mimvista Corp. · 2005 · 2 generations on353descendants
- K060816Mim 4.0 (NeuroMimvista Corp. · 2006 · 3 generations on350descendants
- K071964Mim 4.1 (Seastar)Mimvista Corp. · 2007 · 4 generations on287descendants
- K091373Syngo TruedSiemens Medical Solutions USA, Inc. · 2009 · 5 generations on200descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K885054 | System Seventy Seven | Scinticor, Inc. | 1989 | — |
| 0 (this device) | K982855 | Digirad 2020TC Spect Imaging System | Digirad Corp. | 1998 | — |
| +1 | K011572 | Quantitative Gated Spect (QGS), Quantitative Perfusion Spect (QPS) | Digirad Corp. | 2001 | — |
| +2 | K052379 | Mim 3.5 (Circa) | Mimvista Corp. | 2005 | — |
| +3 | K060816 | Mim 4.0 (Neuro | Mimvista Corp. | 2006 | 1 |
| +4 | K071964 | Mim 4.1 (Seastar) | Mimvista Corp. | 2007 | 2 |
| +5 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 4 | 0 |
| 2007 | 7 | 0 |
| 2008 | 5 | 0 |
| 2009 | 2 | 0 |
| 2010 | 7 | 0 |
| 2011 | 8 | 0 |
| 2012 | 8 | 0 |
| 2013 | 7 | 0 |
| 2014 | 11 | 0 |
| 2015 | 12 | 0 |
| 2016 | 16 | 0 |
| 2017 | 17 | 0 |
| 2018 | 26 | 0 |
| 2019 | 24 | 0 |
| 2020 | 28 | 0 |
| 2021 | 27 | 0 |
| 2022 | 32 | 0 |
| 2023 | 31 | 0 |
| 2024 | 28 | 0 |
| 2025 | 40 | 1 |
| 2026 | 37 | 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.
1 device in this family has a Class I recall. 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? (2)
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 |
|---|---|---|---|
| * | K885054 | System Seventy SevenSummary page 1…tem Common/Usual Name: SPECT Gamma Camera System Trade Name: Digirad 2020zc SPECT Imaging System C. Predicate Device: Sponsor Product 510(k) No. SCINTICOR SIM 400 System K885054 SITCO Inc. NuQuest Nuclear Medicine K953255 Computer ‘ D. Device Description: The Digirad SPECT Rotating Chair is an option to D… | 1989 |
| * | K953255 | Nuquest Nuclear Medicine ComputerSummary page 1…stem Trade Name: Digirad 2020zc SPECT Imaging System C. Predicate Device: Sponsor Product 510(k) No. SCINTICOR SIM 400 System K885054 SITCO Inc. NuQuest Nuclear Medicine K953255 Computer ‘ D. Device Description: The Digirad SPECT Rotating Chair is an option to Digirad 2020¢c Imager™ so that SPECT imaging… | 1995 |
What descends from it? (381)
See all 3817 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K011572 | Quantitative Gated Spect (QGS), Quantitative Perfusion Spect (QPS) | 2001 | 354 |
| K053062 | Cardiarc Spect Imaging Device, Model CQ103-RV2 | 2006 | 16 |
| K051549 | Cardius-1, Cardius-2, Cardius-3, 2020TC Spect Imaging System | 2005 | 8 |
| K052430 | Cardius-1, Cardius-2, Cardius-3, 2020TC Spect Imaging System | 2005 | 7 |
| K070542 | Cardius 1, 2 and 3 Xpo and 2020TC Spect Imaging Systems | 2007 | 6 |
| K100838 | Ergo Imaging System | 2010 | 2 |
| K082368 | Cardius-1, -2, -3, and Cardius 1,2,3 Xpo Spect Imaging Systems, 2020TC Spect Imaging… | 2008 | 1 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH · 2025 · 10 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
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?
The Digirad 2020¢c SPECT Imaging System is intended for use in the generation of both planar and Single Photon Emission Computed Tomography (SPECT) clinical images in Nuclear Medicine applications. The Digirad SPECT Rotating Chair is used in conjunction with the Digirad 2020¢c Imager™ to obtain SPECT images in patients who are seated in an upright position.
Specifically, the 2020¢c Imager™ is intended to image the distribution of radionuclides in the body by means of a photon radiation detector. In so doing, the system produces images depicting the anatomical distribution of radioisotopes within the human body for interpretation by authorized medical personnel.
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/K982855 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982855: Digirad 2020TC Spect Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982855
Report an extraction error
Are you the manufacturer?
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