# K982795: Philips Bucky Vision

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems, Inc.
- Decided: Nov 24, 1998 after 106 days
- Product code: MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager))
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: 17 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K931071 (1994). 3 ancestors in all.
141 later devices descend from it; 11 cite it directly.
0 of 145 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945278: Philips Bucky Diagnost Family, Philips Medical Systems North America, Inc. (1994). Our OCR of the scanned summary read K945287, FDA’s number for Inhealth Blom-Singer Indwelling Valved Insert Accessory… (Helix Medical, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Philips bucky Diagnost System with Radiographic Screen Film Systems”.
- K973206: Sterling Diagnostic Imaging Direct Radiography, Sterling Diagnostic Imaging, Inc. (1997) Summary page 2.
- K931071: Philips Thoravision, Philips Medical Systems, Inc. (1994) Summary page 2.

## Most influential descendants
- 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
- K120020: Vivix-S (2012), 30 descendants of its own

## Recalls of this device
- Mar 17, 2014 · Class II · Z-1503-2014: The footboard of Patient support for stitching can be fixed in upper position. When the fix clamp (hook) is not correctly adjusted into its correct position, the footboard is not securely held.
- Aug 8, 2013 · Class II · Z-2059-2013: The mirror icon on the bottom of each image could be misinterpreted as a RIGHT lead marker for side indication if the image is mirrored within a PACS system.
- Jan 16, 2013 · Class II · Z-1448-2013: Installation Acceptance Test Document (IATD) non compliant with regulations. Records shows table height measurements out of specification with the consequence of potential system mis-alignment.
- Jan 16, 2013 · Class II · Z-1447-2013: Installation Acceptance Test Document (IATD) non compliant with regulations IATDs (Installation Acceptance Test could not be located or different templates have been used
- Oct 30, 2012 · Class II · Z-0475-2013: With Digital Diagnost R2.0.2 a mirrored "R in a circle" is burnt into the image (if mirrored) in the lower right corner of the image. When such an image is mirrored back inside the PACS system, an unm
- Oct 30, 2012 · Class II · Z-0900-2013: When the operator for a wall stand view selects an "image rotation" different from default, or such image rotation is preset in the examination database, then the resulting image may be rotated in the
- Oct 25, 2012 · Class II · Z-0884-2013: When the operator for a wall stand view selects an "image rotation" different from default, or such image rotation is preset in the examination database, then the resulting image may be rotated in the
- Sep 12, 2012 · Class II · Z-2494-2012: Hook does not securely hold the footplate in vertical position, causing the footplate to disengage and may fall on patient or operator
- Sep 6, 2012 · Class II · Z-2465-2012: The Wireless Portable Detector (WPD) is not fixed securely inside the Mobile Detector Holder and may fall down
- Aug 14, 2012 · Class II · Z-2384-2012: Creepage Distance between the two primary phases in the GEO Transformer is 4.5 mm.does not meet (IEC) International standard of 5.5 mm.
- May 22, 2012 · Class II · Z-1818-2012: With Digital Diagnost (DIDI) R 2.0.2 a mirrored "R in a circle" is burnt into the image (if mirrored) in the lower right corner of the image. When such an image is mirrored back inside the PACS system
- Apr 3, 2012 · Not classified · Z-1464-2012: Potential misdiagnosis due to improperly automatically stitched images, improper image ruler handling.
- Nov 1, 2011 · Not classified · Z-0313-2012: Missing a small, metal protective cover on the bottom side of the control handle for the ceiling suspension. exposes printed circuit
- Sep 9, 2010 · Not classified · Z-0022-2011: 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-0847-2010: Device failed to display appropriate labels indicating Radiation Symbol along with the required wording.
- Dec 13, 2007 · Not classified · Z-2422-2010: When using DICOM print functionality, the printed images may contain data for the wrong patient.
- Jul 23, 2007 · Not classified · Z-0908-2007: 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

## Indications for use
The Philips BuckyVision is intended for use in general radiographic examinations and applications wherever conventional screen-film systems may be used (excluding fluoroscopy, angiography, and mammography).

Source page: https://510kreport.com/device/K982795
Methodology: https://510kreport.com/methodology