510(k) · Cleared
Recalled · Class II · 2017SCX System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
General Electric Co. · JAA System, X-Ray, Fluoroscopic, Image-Intensified
Cleared on Jun 16, 1986 after a 13-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 227 later devices descend from it. It has been recalled 3 times.
- Decided
- Jun 16, 1986
- Review
- 13 days
- Class
- Class II
- Product code
- JAA
- Recalls
- 3
- Predicates
- 0
227 later devices descend from it, 2 citing it directly.
- This deviceK862120 SCX SystemGeneral Electric Co. · 1986
- Descendant · cites it directly · 221 of its ownK982196 Digital Radiographic Imaging SystemGE Medical Systems · 1998
- Descendant · 2 generations on · 104 of its ownK992066 Revolution TX/I Digital Radiographic Table SystemGE Medical Systems · 1999
- Descendant · 3 generations on · 103 of its ownK012389 Revolution XR/D Digital Radiographic Imaging SystemGe Medical Systems, Inc. · 2001 · Recalled
- Descendant · 2 generations on · 103 of its ownK992794 Stingray DR, Model 1Infimed, Inc. · 1999
- Descendant · 3 generations on · 78 of its ownK024147 Paxscan 4030 Medical Digital Imaging SystemVarian Medical Systems, Inc. · 2003
Showing 5 of 227 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 227 · See all- K982196Digital Radiographic Imaging SystemGE Medical Systems · 1998 · cites it directly221descendants
- K992066Revolution TX/I Digital Radiographic Table SystemGE Medical Systems · 1999 · 2 generations on104descendants
- K012389Revolution XR/D Digital Radiographic Imaging SystemGe Medical Systems, Inc. · 2001 · 3 generations on103descendants
- K992794Stingray DR, Model 1Infimed, Inc. · 1999 · 2 generations on103descendants
- K024147Paxscan 4030 Medical Digital Imaging SystemVarian Medical Systems, Inc. · 2003 · 3 generations on78descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K862120 | SCX System | General Electric Co. | 1986 | — |
| +1 | K982196 | Digital Radiographic Imaging System | GE Medical Systems | 1998 | — |
| +2 | K992066 | Revolution TX/I Digital Radiographic Table System | GE Medical Systems | 1999 | — |
| +3 | K012389 | Revolution XR/D Digital Radiographic Imaging System | Ge Medical Systems, Inc. | 2001 | 4 |
| +2 | K992794 | Stingray DR, Model 1 | Infimed, Inc. | 1999 | — |
| +3 | K024147 | Paxscan 4030 Medical Digital Imaging System | Varian Medical Systems, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2001 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 4 | 0 |
| 2010 | 6 | 0 |
| 2011 | 11 | 0 |
| 2012 | 10 | 0 |
| 2013 | 10 | 0 |
| 2014 | 18 | 0 |
| 2015 | 15 | 0 |
| 2016 | 18 | 0 |
| 2017 | 15 | 0 |
| 2018 | 18 | 0 |
| 2019 | 14 | 0 |
| 2020 | 9 | 0 |
| 2021 | 12 | 0 |
| 2022 | 16 | 0 |
| 2023 | 7 | 0 |
| 2024 | 9 | 0 |
| 2025 | 10 | 0 |
| 2026 | 9 | 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.
Planning a device in JAA? 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 JAA device
- #1 K253103 Nexus DRF Digital X-ray Imaging Systemscore 13.2 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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? (227)
See all 2272 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 6, 2017 | Class II | Z-2179-2017 | Device Design | Reported incidents of a patient step detaching from the table. A fall from a patient step detaching while in use could result in an injury to a patient or operator. |
| Nov 21, 2016 | Class II | Z-0909-2017 | Nonconforming Material/Component | GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, ADVANTX and Innova 2000 systems. |
| Nov 8, 2013 | Class II | Z-0804-2014 | Employee error | Missing screws in the overhead Video Monitor Suspension. GE discovered that the 4 outer screws that hold the overhead Video Monitor Suspension to the carriage were missing since installation of the system. GE is not aware of any fall of… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K982196 (GE Medical Systems, 1998) has gone furthest, with 221 descendants of its own.
How does its category compare?
All JAA devicesJAA System, X-Ray, Fluoroscopic, Image-Intensified: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JAA
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAA
89in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAA
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAA
33in 2025
MAUDE reports naming product code JAA, 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 | 1 | — | 35 | 9,517 |
| 2008 | 6 | 18 | 21 | 9,484 |
| 2009 | 0 | — | 18 | 12,040 |
| 2010 | 1 | — | 6 | 5,803 |
| 2011 | 4 | 48 | 7 | 14,000 |
| 2012 | 1 | — | 2 | 11,684 |
| 2013 | 6 | 129 | 3 | 13,706 |
| 2014 | 6 | 276 | 1 | 10,265 |
| 2015 | 3 | 197 | 1 | 2,922 |
| 2016 | 2 | — | 7 | 35 |
| 2017 | 1 | — | 3 | 56 |
| 2018 | 3 | 30 | 1 | 36 |
| 2019 | 6 | 49 | 2 | 49 |
| 2020 | 4 | 39 | 2 | 39 |
| 2021 | 6 | 104 | 2 | 35 |
| 2022 | 1 | — | 5 | 34 |
| 2023 | 2 | — | 9 | 41 |
| 2024 | 3 | 89 | 2 | 25 |
| 2025 | 2 | — | 4 | 33 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K862120 · printed Nov 4, 2026
Cite this page
510(k) Report. “K862120: SCX System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K862120
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026