510(k) · Cleared
Recalled · Class II · 2014Philips Bucky Vision
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems, Inc. · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Nov 24, 1998 as substantially equivalent to K945278 (Philips Medical Systems North America, Inc., 1994) and 2 other predicates after a 106-day review. Its family tree reaches back 1 generation to 1994. 141 later devices descend from it. It has been recalled 17 times.
- Decided
- Nov 24, 1998
- Review
- 106 days
- Class
- Class II
- Product code
- MQB
- Recalls
- 17
- Predicates
- 3
Its longest line of descent runs back 1 generation to K931071 (1994). 3 ancestors in all. 141 later devices descend from it, 11 citing it directly.
- Root · 1 generation backK931071 Philips ThoravisionPhilips Medical Systems, Inc. · 1994 · Recalled
- This deviceK982795 Philips Bucky VisionPhilips Medical Systems, Inc. · 1998
- Descendant · cites it directly · 103 of its ownK992794 Stingray DR, Model 1Infimed, Inc. · 1999
- Descendant · cites it directly · 78 of its ownK024147 Paxscan 4030 Medical Digital Imaging SystemVarian Medical Systems, Inc. · 2003
- Descendant · cites it directly · 41 of its ownK090625 Wireless Portable Detector FD-W17Philips Medical Systems North America Co. · 2009 · Recalled
- Descendant · 2 generations on · 34 of its ownK092669 DX-D Imaging PackageAgfa Healthcare N.V. · 2009 · Recalled
- Descendant · 2 generations on · 30 of its ownK120020 Vivix-SVieworks Co., Ltd. · 2012
Showing 5 of 141 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 141 · See all- K992794Stingray DR, Model 1Infimed, Inc. · 1999 · cites it directly103descendants
- K024147Paxscan 4030 Medical Digital Imaging SystemVarian Medical Systems, Inc. · 2003 · cites it directly78descendants
- K090625Wireless Portable Detector FD-W17Philips Medical Systems North America Co. · 2009 · cites it directly41descendants
- K092669DX-D Imaging PackageAgfa Healthcare N.V. · 2009 · 2 generations on34descendants
- K120020Vivix-SVieworks Co., Ltd. · 2012 · 2 generations on30descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K931071 | Philips Thoravision | Philips Medical Systems, Inc. | 1994 | 1 |
| 0 (this device) | K982795 | Philips Bucky Vision | Philips Medical Systems, Inc. | 1998 | — |
| +1 | K992794 | Stingray DR, Model 1 | Infimed, Inc. | 1999 | — |
| +1 | K024147 | Paxscan 4030 Medical Digital Imaging System | Varian Medical Systems, Inc. | 2003 | — |
| +1 | K090625 | Wireless Portable Detector FD-W17 | Philips Medical Systems North America Co. | 2009 | 28 |
| +2 | K092669 | DX-D Imaging Package | Agfa Healthcare N.V. | 2009 | 1 |
| +2 | K120020 | Vivix-S | Vieworks Co., Ltd. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 6 | 0 |
| 2010 | 6 | 0 |
| 2011 | 10 | 0 |
| 2012 | 5 | 0 |
| 2013 | 11 | 0 |
| 2014 | 12 | 0 |
| 2015 | 5 | 0 |
| 2016 | 10 | 0 |
| 2017 | 12 | 0 |
| 2018 | 5 | 0 |
| 2019 | 9 | 0 |
| 2020 | 7 | 0 |
| 2021 | 12 | 0 |
| 2022 | 5 | 0 |
| 2023 | 5 | 0 |
| 2024 | 3 | 0 |
| 2025 | 5 | 0 |
| 2026 | 5 | 0 |
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 MQB? 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 MQB device
- #1 K201528 Yushan X-Ray Flat Panel Detector with DROCscore 21.5 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K945278 | Philips Bucky Diagnost Family 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”. | 1994 |
| * | K973206 | Sterling Diagnostic Imaging Direct RadiographySummary page 2…hilips bucky Diagnost System 510(k) Number : K945287, with Radiographic Screen Film Systems, the Sterling Diagnostic Imaging Direct Radiography™ device: 510(k) Number : K973206 and the Philips Thoravision 510(k) Number : K931071. Therefore the Philips BuckyVision system complies to the same or equivalent… | 1997 |
| * | K931071 | Philips ThoravisionSummary page 2…, with Radiographic Screen Film Systems, the Sterling Diagnostic Imaging Direct Radiography™ device: 510(k) Number : K973206 and the Philips Thoravision 510(k) Number : K931071. Therefore the Philips BuckyVision system complies to the same or equivalent standards and has the same intended use as the pred… | 1994 |
What descends from it? (141)
See all 14111 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K992794 | Stingray DR, Model 1 | 1999 | 103 |
| K024147 | Paxscan 4030 Medical Digital Imaging System | 2003 | 78 |
| K090625 | Wireless Portable Detector FD-W17 | 2009 | 41 |
| K063781 | Philips XD-S Direct Radiography Workstation/Package | 2007 | 16 |
| K182973 | DigitalDiagnost C90 | 2019 | 3 |
| K141381 | Duradiagnost | 2014 | 3 |
| K073165 | Drad-3000E, Radrex-I | 2007 | 3 |
| K082494 | DRAD3000E/Radrex-I | 2008 | 2 |
| K131483 | Philips Pixium 4343RC | 2013 | 1 |
| K083503 | DRAD30003/Radrex-I | 2009 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 17, 2014 | Class II | Z-1503-2014 | Process control | 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 | Software design | 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 | Radiation Control for Health and Safety Act | 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 | Radiation Control for Health and Safety Act | 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 | Software design | 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 unmirrored "R in a circle" appears in the… |
| Oct 30, 2012 | Class II | Z-0900-2013 | Software design | 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 wrong direction. When the operator… |
| Oct 25, 2012 | Class II | Z-0884-2013 | Software design | 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 wrong direction. When the operator… |
| Sep 12, 2012 | Class II | Z-2494-2012 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Software change control | 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, an unmirrored "R in a circle"… |
| Apr 3, 2012 | Not classified | Z-1464-2012 | Labeling design | Potential misdiagnosis due to improperly automatically stitched images, improper image ruler handling. |
| Nov 1, 2011 | Not classified | Z-0313-2012 | Process control | 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 | Equipment maintenance | 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 | Radiation Control for Health and Safety Act | Device failed to display appropriate labels indicating Radiation Symbol along with the required wording. |
| Dec 13, 2007 | Not classified | Z-2422-2010 | Software design | When using DICOM print functionality, the printed images may contain data for the wrong patient. |
| Jul 23, 2007 | Not classified | Z-0908-2007 | Other | 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 procedures. |
The 5 latest of 17 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All MQB devicesMQB Solid State X-Ray Imager (Flat Panel/Digital Imager): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MQB
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MQB
127in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQB
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQB
141in 2025
MAUDE reports naming product code MQB, 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 | 13 | 22 | 15 | 25 |
| 2008 | 8 | 15 | 36 | 30 |
| 2009 | 15 | 57 | 19 | 34 |
| 2010 | 11 | 116 | 14 | 39 |
| 2011 | 24 | 102 | 10 | 101 |
| 2012 | 22 | 80 | 8 | 267 |
| 2013 | 21 | 105 | 6 | 159 |
| 2014 | 32 | 102 | 0 | 29 |
| 2015 | 21 | 81 | 0 | 21 |
| 2016 | 22 | 92 | 0 | 26 |
| 2017 | 31 | 30 | 1 | 20 |
| 2018 | 16 | 30 | 4 | 84 |
| 2019 | 22 | 30 | 1 | 45 |
| 2020 | 19 | 28 | 4 | 9 |
| 2021 | 21 | 48 | 1 | 26 |
| 2022 | 31 | 48 | 0 | 13 |
| 2023 | 10 | 30 | 0 | 51 |
| 2024 | 8 | 187 | 0 | 91 |
| 2025 | 8 | 127 | 1 | 141 |
| 2026 | 3 | 245 | 1 | — |
What is it indicated for?
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).
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/K982795 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982795: Philips Bucky Vision.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982795
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026