510(k) · Cleared
Recalled · 2008Philips XD-S Direct Radiography Workstation/Package
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems North America Co. · LLZ System, Image Processing, Radiological
Cleared on Jan 5, 2007 as substantially equivalent to K982795 (Philips Medical Systems, Inc., 1998) and 1 other predicate after a 15-day review. Its family tree reaches back 2 generations to 1992. 16 later devices descend from it. It has been recalled once.
- Decided
- Jan 5, 2007
- Review
- 15 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K915237 (1992). 7 ancestors in all. 16 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK915237 Philips PCR-Ace SystemPhilips Medical Systems, Inc. · 1992
- 1 generation backK964124 Philips Computed RadiographyPhilips Medical Systems, Inc. · 1996 · Recalled
- This deviceK063781 Philips XD-S Direct Radiography Workstation/PackagePhilips Medical Systems North America Co. · 2007
- Descendant · cites it directly · 15 of its ownK140771 Philips Eleva WorkspotPhilips Medical Systems Dmc GmbH · 2014
- Descendant · 2 generations on · 6 of its ownK141736 Philips Prograde; Philips Eleva Workspot for Digital DiagnostPhilips Medical Systems Dmc GmbH · 2014 · Recalled
- Descendant · 2 generations on · 3 of its ownK203188 ADDH&abyz Co., Ltd. · 2021
- Descendant · 3 generations on · 3 of its ownK182973 DigitalDiagnost C90Philips Medical Systems Dmc GmbH · 2019
- Descendant · 3 generations on · 2 of its ownK213497 ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW)H&abyz Co., Ltd. · 2021
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K140771Philips Eleva WorkspotPhilips Medical Systems Dmc GmbH · 2014 · cites it directly15descendants
- K141736Philips Prograde; Philips Eleva Workspot for Digital DiagnostPhilips Medical Systems Dmc GmbH · 2014 · 2 generations on6descendants
- K203188ADDH&abyz Co., Ltd. · 2021 · 2 generations on3descendants
- K182973DigitalDiagnost C90Philips Medical Systems Dmc GmbH · 2019 · 3 generations on3descendants
- K213497ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW)H&abyz Co., Ltd. · 2021 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K915237 | Philips PCR-Ace System | Philips Medical Systems, Inc. | 1992 | — |
| −1 | K964124 | Philips Computed Radiography | Philips Medical Systems, Inc. | 1996 | 3 |
| 0 (this device) | K063781 | Philips XD-S Direct Radiography Workstation/Package | Philips Medical Systems North America Co. | 2007 | — |
| +1 | K140771 | Philips Eleva Workspot | Philips Medical Systems Dmc GmbH | 2014 | — |
| +2 | K141736 | Philips Prograde; Philips Eleva Workspot for Digital Diagnost | Philips Medical Systems Dmc GmbH | 2014 | 6 |
| +2 | K203188 | ADD | H&abyz Co., Ltd. | 2021 | — |
| +3 | K182973 | DigitalDiagnost C90 | Philips Medical Systems Dmc GmbH | 2019 | — |
| +3 | K213497 | ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW) | H&abyz Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 6 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 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 LLZ? 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 LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K982795 | Philips Bucky VisionSummary page 2…tially equivalent to the Philips DigitalDiagnost, which received FDA marketing on November 25, 1998, under the name Philips Bucky Vision in 510(k) Number K982795. In relation to the image plate reader connection, the PHILIPS XD-S is substantially equivalent to the Philips Co… | 1998 |
| * | K964124 | Philips Computed RadiographySummary page 2…the PHILIPS XD-S is substantially equivalent to the Philips Computed Radiography, which received FDA marketing on December 18, 1996, under 510(k) Number K964124. Section 5 Summary of Saf… | 1996 |
What descends from it? (16)
See all 161 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140771 | Philips Eleva Workspot | 2014 | 15 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 9, 2008 | Not classified | Z-2194-2010 | Other | Potential for bright artifacts to appear on the patient image from a previous exposure. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 10.0 years on median.
- 4 of the 7 ancestors have a recall of any class.
- Of its descendants, K140771 (Philips Medical Systems Dmc GmbH, 2014) has gone furthest, with 15 descendants of its own.
- 10 other devices also cite its predicate K982795.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, 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 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
As a part of a radiographic system, the PhilipsXD-S is intended to acquire, process, store, display, and export digital radiographic images. The Philips XD-S is suitable for all routine radiography exams, including specialist areas like intensive care, trauma, or pediatric work, excluding mammography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063781 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063781: Philips XD-S Direct Radiography Workstation/Package.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063781
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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