510(k) · Cleared
Recalled · Class II · 2024Silhouette FC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems, Inc. · KPR System, X-Ray, Stationary
Cleared on Oct 1, 1999 after a 15-day review. The FDA summary names no predicate by number. It has been recalled 13 times.
- Decided
- Oct 1, 1999
- Review
- 15 days
- Class
- Class II
- Product code
- KPR
- Recalls
- 13
- Predicates
- 0
The FDA summary names no predicate by number.
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 KPR? 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 KPR device
- #1 K242119 Innovision-Exiiscore 17.0 · 9 generations · no Class I recall
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What was it cleared against?
The FDA summary names no predicate by number.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 24, 2024 | Class II | Z-0550-2025 | Equipment maintenance | Steel cables in the Wall Stand for certain Proteus XR/a systems serviced by GE HealthCare have not been replaced at the intervals detailed in the Preventative Maintenance Action List. |
| Jul 12, 2024 | Class II | Z-2733-2024 | Error in labeling | The XR system, Proteus XR/a, does not have a de-installation manual describing process steps for de-installing the devices. De-installation instruction process steps must be followed when de-installing these devices to avoid personnel… |
| Aug 9, 2019 | Class II | Z-2449-2019 | Device Design | Intermittently not receiving an audible exposure indication upon completion of an exposure on the Proteus stationary radiographic system. |
| Mar 29, 2019 | Class II | Z-1752-2019 | Device Design | There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging. |
| Jan 30, 2015 | Class II | Z-1248-2015 | Device Design | Potential breakage of the steel cable which supports the bucky device in certain wall stands of Proteus XR/a X-ray imaging systems. A fall of a bucky while the system is in use could result in an injury to a patient or operator. |
| Dec 8, 2014 | Class II | Z-0954-2015 | Nonconforming Material/Component | GE Healthcare has recently become aware of a potential safety issue involving the breakage of the two steel cables which support the bucky device in the wall stand of Proteus XR/a X-ray imaging systems. No injuries reported. |
| Jun 4, 2014 | Class II | Z-1988-2014 | Equipment maintenance | GE Healthcare has become aware of a potential safety issue due to a collimator installation error during a service maintenance activity involving the Proteus XR/a and Revolution XR/d X-ray imaging systems. . There was a reported incident… |
| Aug 13, 2009 | Not classified | Z-0526-2010 | Nonconforming Material/Component | Certain GE Radiographic fixed X-ray tables (Proteus XR/a, Revolution XR/d, and Definium 8000) were found to have tabletops that move unexpectedly in a bi-directional mode. In rare cases, a malfunction may occur, which could result in the… |
| Nov 1, 2007 | Not classified | Z-0842-2008 | Process control | The warning label that is required by 21 CFR 1020.30(j) was not on the control console of the Proteus XR/a Radiographic X-ray System, Model 2259976. |
| Mar 29, 2007 | Not classified | Z-1713-2008 | Radiation Control for Health and Safety Act | The actual average illuminance for the collimators are approximately 140-lux. This does not meet the 160-lux requirement. GE will be correcting the units by replacing all collimators. |
| May 31, 2006 | Class II | Z-1790-2012 | Device Design | An incident was reported that an operator's finger was pinched between the fixed roller and the gliding tabletop of a Proteus XR/a Table while moving the tabletop with the thumb placed over its edge and fingers underneath |
| May 31, 2006 | Not classified | Z-1087-2007 | Other | Labeling; failure to properly label per 21 CFR 1010.2 and 1010.3 -The Operator Console of the Proteus XR/a General Purpose Radiographic Systems were not properly labeled. |
| Dec 30, 2004 | Not classified | Z-0219-05 | Other | Units have a defect in accordance with 21 CFR 1003.2 because an incorrect exposure can occur. |
The 5 latest of 13 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All KPR devicesKPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KPR
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KPR
155in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KPR
7in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KPR
39in 2025
MAUDE reports naming product code KPR, 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 | 12 | 31 | 10 | 120 |
| 2008 | 15 | 48 | 10 | 95 |
| 2009 | 9 | 35 | 5 | 61 |
| 2010 | 9 | 126 | 3 | 82 |
| 2011 | 9 | 152 | 5 | 103 |
| 2012 | 11 | 58 | 1 | 74 |
| 2013 | 5 | 163 | 5 | 24 |
| 2014 | 10 | 108 | 8 | 34 |
| 2015 | 18 | 81 | 1 | 59 |
| 2016 | 11 | 84 | 4 | 18 |
| 2017 | 6 | 75 | 3 | 31 |
| 2018 | 15 | 30 | 4 | 36 |
| 2019 | 12 | 33 | 1 | 77 |
| 2020 | 16 | 39 | 1 | 41 |
| 2021 | 6 | 55 | 0 | 37 |
| 2022 | 8 | 43 | 2 | 27 |
| 2023 | 9 | 76 | 4 | 39 |
| 2024 | 11 | 162 | 1 | 34 |
| 2025 | 8 | 155 | 7 | 39 |
| 2026 | 6 | 197 | 0 | — |
What is it indicated for?
The Silhouette FC is intended for use in generating radiographic images of human anatomy in all general purpose diagnostic procedures. This device is not intended for mammographic applications.
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/K993090 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993090: Silhouette FC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993090
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026