# K945278: Philips Bucky Diagnost Family

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems North America, Inc.
- Decided: Dec 14, 1994 after 47 days
- Product code: KPR (System, X-Ray, Stationary)
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
150 later devices descend from it; 2 cite it directly.
0 of 151 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K982795: Philips Bucky Vision (1998), 141 descendants of its own
- K992794: Stingray DR, Model 1 (1999), 103 descendants of its own
- K024147: Paxscan 4030 Medical Digital Imaging System (2003), 78 descendants of its own
- K090625: Wireless Portable Detector FD-W17 (2009), 41 descendants of its own
- K092669: DX-D Imaging Package (2009), 34 descendants of its own

## Recalls of this device
- Apr 7, 2020 · Class II · Z-1806-2020: If the shaft breaks due to material fatigue, the trauma arm can fall down and may result in injury.
- Jul 22, 2015 · Class II · Z-0766-2016: If arm is not fastened securely it could fall down.
- Aug 19, 2014 · Class II · Z-0364-2016: The hook does not securely hold the footplate in vertical position. Therefore the footplate can fall or swing down and may hurt the operator or patient.
- Jan 16, 2013 · Class II · Z-1450-2013: An inspection of IATD (Installation Acceptance Test Document)IA SID (Source Image Distance) records shows table height measurements out of specification with the consequence of potential system mis-al
- Jan 16, 2013 · Class II · Z-1449-2013: An inspection shows several IATDs (Installation Acceptance Test could not be located or different templates have been used
- Sep 9, 2010 · Not classified · Z-0021-2011: Potential of broken strands in the main steel cable supporting the accessory holder used with BuckyDiagnost and DigitalDiagnost X-ray systems.
- Jan 21, 2010 · Not classified · Z-0848-2010: Device failed to display appropriate labels indicating Radiation Symbol along with the required wording.
- Jul 23, 2007 · Not classified · Z-0907-2007: Units do not comply with the requirement to provide automatic beam limitation within +/- 3 degrees of horizontal, vertical, and perpendicular to the plane of the image receptor during radiographic pro
- Feb 24, 2005 · Not classified · Z-1084-05: Systems do not comply with the labeling performance standards.
- Nov 18, 2003 · Not classified · Z-0268-04: Support chain attachment on the Bucky carriage may fail and cause the counter weights or X-ray tube to fall.

Source page: https://510kreport.com/device/K945278
Methodology: https://510kreport.com/methodology