# K993090: Silhouette FC

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, Inc.
- Decided: Oct 1, 1999 after 15 days
- Product code: KPR (System, X-Ray, Stationary)
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Recalls of this device
- Oct 24, 2024 · Class II · Z-0550-2025: 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: 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-installin
- Aug 9, 2019 · Class II · Z-2449-2019: 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: 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: 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 inju
- Dec 8, 2014 · Class II · Z-0954-2015: 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 system
- Jun 4, 2014 · Class II · Z-1988-2014: 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 sys
- Aug 13, 2009 · Not classified · Z-0526-2010: 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
- Nov 1, 2007 · Not classified · Z-0842-2008: 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: 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: 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 a
- May 31, 2006 · Not classified · Z-1087-2007: 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: Units have a defect in accordance with 21 CFR 1003.2 because an incorrect exposure can occur.

## Indications for use
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.

Source page: https://510kreport.com/device/K993090
Methodology: https://510kreport.com/methodology