510(k) · Cleared
ClearedErgo Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Digirad Corp. · IYX Camera, Scintillation (Gamma)
Cleared on Apr 23, 2010 as substantially equivalent to K961104 (Digirad Corp., 1997) and 3 other predicates after a 30-day review. Its family tree reaches back 5 generations to 1989. 2 later devices descend from it.
- Decided
- Apr 23, 2010
- Review
- 30 days
- Class
- Class I
- Product code
- IYX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K885054 (1989). 15 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK885054 System Seventy SevenScinticor, Inc. · 1989
- 4 generations backK982855 Digirad 2020TC Spect Imaging SystemDigirad Corp. · 1998
- 3 generations backK051549 Cardius-1, Cardius-2, Cardius-3, 2020TC Spect Imaging SystemDigirad Corp. · 2005
- 2 generations backK052430 Cardius-1, Cardius-2, Cardius-3, 2020TC Spect Imaging SystemDigirad Corp. · 2005
- 1 generation backK070542 Cardius 1, 2 and 3 Xpo and 2020TC Spect Imaging SystemsDigirad Corp. · 2007
- This deviceK100838 Ergo Imaging SystemDigirad Corp. · 2010
- Descendant · cites it directly · 0 of its ownK123408 Ergo Imaging SystemDigirad Corp. · 2013
- Descendant · cites it directly · 0 of its ownK110384 Dilon 6800 Acella (Acella)Dilon Technologies, Inc. · 2011
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 |
|---|---|---|---|---|---|
| −5 | K885054 | System Seventy Seven | Scinticor, Inc. | 1989 | — |
| −4 | K982855 | Digirad 2020TC Spect Imaging System | Digirad Corp. | 1998 | — |
| −3 | K051549 | Cardius-1, Cardius-2, Cardius-3, 2020TC Spect Imaging System | Digirad Corp. | 2005 | — |
| −2 | K052430 | Cardius-1, Cardius-2, Cardius-3, 2020TC Spect Imaging System | Digirad Corp. | 2005 | — |
| −1 | K070542 | Cardius 1, 2 and 3 Xpo and 2020TC Spect Imaging Systems | Digirad Corp. | 2007 | — |
| 0 (this device) | K100838 | Ergo Imaging System | Digirad Corp. | 2010 | — |
| +1 | K123408 | Ergo Imaging System | Digirad Corp. | 2013 | — |
| +1 | K110384 | Dilon 6800 Acella (Acella) | Dilon Technologies, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 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 IYX? 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 IYX device
- #1 K230221 QDOSE® Multi-purpose Voxel Dosimetry…score 6.2 · 2 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K961104 | Notebook ImagerSummary page 2…ftware, with minor modifications required for use with the 3mm pixel size RIM detector modules. The 2020tc Imager was initially marketed as the Digirad Notebook Imager (K961104), then . re-branded as the 2020tc Imaging System (K982855) when it was used in conjunction with the SPECTour Rotating Chair to ob… | 1997 |
| * | K982855 | Digirad 2020TC Spect Imaging SystemSummary page 1…a Camera), cleared on May 28, 1997, under K9641104, and (2) 2020tc SPECT Imaging System and the SPECTour Chair (SPECT Imaging System), cleared on November 9, 1998 under K982855, and (3) Cardius-1, Cardius-2, Cardius-3, 2020tc SPECT Imaging System, cleared on July 13, 2005 under K051549, and (4) Cardius… | 1998 |
| * | K051549 | Cardius-1, Cardius-2, Cardius-3, 2020TC Spect Imaging SystemSummary page 1…(SPECT Imaging System), cleared on November 9, 1998 under K982855, and (3) Cardius-1, Cardius-2, Cardius-3, 2020tc SPECT Imaging System, cleared on July 13, 2005 under K051549, and (4) Cardius XPO series and 2020tc SPECT Imaging Systems cleared on March 23, 2007 under K070542. E. Device Description Th… | 2005 |
| * | K070542 | Cardius 1, 2 and 3 Xpo and 2020TC Spect Imaging SystemsSummary page 1…dius-3, 2020tc SPECT Imaging System, cleared on July 13, 2005 under K051549, and (4) Cardius XPO series and 2020tc SPECT Imaging Systems cleared on March 23, 2007 under K070542. E. Device Description The proposed changes involve modifications to the 2020tc Imaging System to increase size of the detector… | 2007 |
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?
- The line of descent spans 21 years and passes through 2 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 15 ancestors has a recall of any class.
- Of its descendants, K123408 (Digirad Corp., 2013) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K961104.
How does its category compare?
All IYX devicesIYX Camera, Scintillation (Gamma): FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · IYX
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · IYX
82in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYX
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYX
1in 2022
MAUDE reports naming product code IYX, 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 | 2 | — | 0 | 11 |
| 2008 | 2 | — | 0 | 10 |
| 2009 | 2 | — | 0 | 8 |
| 2010 | 4 | 82 | 0 | 5 |
| 2011 | 3 | 82 | 0 | 6 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 4 |
| 2016 | 2 | — | 0 | 2 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 2 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ergo Imaging System 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 radicisotopes 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/K100838 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100838: Ergo 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/K100838
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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