510(k) · Cleared
ClearedSystem Seventy Seven
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Scinticor, Inc. · IYX Camera, Scintillation (Gamma)
Cleared on Apr 19, 1989 after a 133-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 394 devices in its family, counting itself, has a Class I recall. 393 later devices descend from it.
- Decided
- Apr 19, 1989
- Review
- 133 days
- Class
- Class I
- Product code
- IYX
- Recalls
- None
- Predicates
- 0
393 later devices descend from it, 3 citing it directly. 1 of the 394 devices in this family, counting this one, has a Class I recall.
- This deviceK885054 System Seventy SevenScinticor, Inc. · 1989
- Descendant · cites it directly · 381 of its ownK982855 Digirad 2020TC Spect Imaging SystemDigirad Corp. · 1998
- Descendant · 2 generations on · 354 of its ownK011572 Quantitative Gated Spect (QGS), Quantitative Perfusion Spect (QPS)Digirad Corp. · 2001
- Descendant · 3 generations on · 353 of its ownK052379 Mim 3.5 (Circa)Mimvista Corp. · 2005
- Descendant · 4 generations on · 350 of its ownK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- Descendant · 5 generations on · 287 of its ownK071964 Mim 4.1 (Seastar)Mimvista Corp. · 2007 · Recalled
Showing 5 of 393 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…11 generations on · 2025
Most influential descendants
Showing 5 of 393 · See all- K982855Digirad 2020TC Spect Imaging SystemDigirad Corp. · 1998 · cites it directly381descendants
- K011572Quantitative Gated Spect (QGS), Quantitative Perfusion Spect (QPS)Digirad Corp. · 2001 · 2 generations on354descendants
- K052379Mim 3.5 (Circa)Mimvista Corp. · 2005 · 3 generations on353descendants
- K060816Mim 4.0 (NeuroMimvista Corp. · 2006 · 4 generations on350descendants
- K071964Mim 4.1 (Seastar)Mimvista Corp. · 2007 · 5 generations on287descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K885054 | System Seventy Seven | Scinticor, Inc. | 1989 | — |
| +1 | K982855 | Digirad 2020TC Spect Imaging System | Digirad Corp. | 1998 | — |
| +2 | K011572 | Quantitative Gated Spect (QGS), Quantitative Perfusion Spect (QPS) | Digirad Corp. | 2001 | — |
| +3 | K052379 | Mim 3.5 (Circa) | Mimvista Corp. | 2005 | — |
| +4 | K060816 | Mim 4.0 (Neuro | Mimvista Corp. | 2006 | 1 |
| +5 | K071964 | Mim 4.1 (Seastar) | Mimvista Corp. | 2007 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 4 | 0 |
| 2007 | 7 | 0 |
| 2008 | 5 | 0 |
| 2009 | 3 | 0 |
| 2010 | 9 | 0 |
| 2011 | 9 | 0 |
| 2012 | 8 | 0 |
| 2013 | 7 | 0 |
| 2014 | 11 | 0 |
| 2015 | 12 | 0 |
| 2016 | 17 | 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), 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 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (393)
See all 3933 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 11 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K982855 (Digirad Corp., 1998) has gone furthest, with 381 descendants of its own.
How does its category compare?
All IYX devicesIYX Camera, Scintillation (Gamma): FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K885054 · printed Nov 6, 2026
Cite this page
510(k) Report. “K885054: System Seventy Seven.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K885054
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026