510(k) · Cleared
ClearedInterventional Workspot
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems Nederland B.V. · LLZ System, Image Processing, Radiological
Cleared on Jan 2, 2013 as substantially equivalent to K031836 (Philips Medical Systems North America Co., 2003) and 4 other predicates after a 247-day review. Its family tree reaches back 9 generations to 1989. 1 later device descends from it.
- Decided
- Jan 2, 2013
- Review
- 247 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 9 generations to K890348 (1989). 52 ancestors in all, the oldest K852353 (1985). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK890348 LC, Cardiac Positioner #B5078AGeneral Electric Co. · 1989 · Recalled
- 5 generations between
- 3 generations backK062650 EP Navigator SoftwarePhilips Medical Systems · 2006
- 2 generations backK101311 EP Navigator R3Philips Medical Systems North America Co. · 2010
- 1 generation backK111245 Heartnavigator Release 1Philips Medical Systems Nederland B.V. · 2011
- This deviceK121296 Interventional WorkspotPhilips Medical Systems Nederland B.V. · 2013
- Descendant · cites it directly · 0 of its ownK181177 Interventional WorkspotPhilips Medical Systems Nederland B.V. · 2018
Show all 9 generations
- Root · 9 generations backK890348 LC, Cardiac Positioner #B5078AGeneral Electric Co. · 1989 · Recalled
- 8 generations backK993037 LCV+ Version 2Ge Medical Systems, Inc. · 2000 · Recalled
- 7 generations backK020055 Philips Integris Allura 9 with FD OptionPhilips Medical Systems · 2002 · Recalled
- 6 generations backK022899 Philips Integris Allura Flat Detector Release 1.0Philips Medical Systems North America Co. · 2002 · Recalled
- 5 generations backK031333 Philips Integris Allura Flat Detector Release 1.2Philips Medical Systems North America, Inc. · 2003 · Recalled
- 4 generations backK031836 Philips Fresco Release 1Philips Medical Systems North America Co. · 2003
- 3 generations backK062650 EP Navigator SoftwarePhilips Medical Systems · 2006
- 2 generations backK101311 EP Navigator R3Philips Medical Systems North America Co. · 2010
- 1 generation backK111245 Heartnavigator Release 1Philips Medical Systems Nederland B.V. · 2011
- This deviceK121296 Interventional WorkspotPhilips Medical Systems Nederland B.V. · 2013
Most influential descendants
Showing 1 of 1 · See all- K181177Interventional WorkspotPhilips Medical Systems Nederland B.V. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K890348 | LC, Cardiac Positioner #B5078A | General Electric Co. | 1989 | 5 |
| −8 | K993037 | LCV+ Version 2 | Ge Medical Systems, Inc. | 2000 | 6 |
| −7 | K020055 | Philips Integris Allura 9 with FD Option | Philips Medical Systems | 2002 | 2 |
| −6 | K022899 | Philips Integris Allura Flat Detector Release 1.0 | Philips Medical Systems North America Co. | 2002 | 8 |
| −5 | K031333 | Philips Integris Allura Flat Detector Release 1.2 | Philips Medical Systems North America, Inc. | 2003 | 25 |
| −4 | K031836 | Philips Fresco Release 1 | Philips Medical Systems North America Co. | 2003 | — |
| −3 | K062650 | EP Navigator Software | Philips Medical Systems | 2006 | — |
| −2 | K101311 | EP Navigator R3 | Philips Medical Systems North America Co. | 2010 | — |
| −1 | K111245 | Heartnavigator Release 1 | Philips Medical Systems Nederland B.V. | 2011 | — |
| 0 (this device) | K121296 | Interventional Workspot | Philips Medical Systems Nederland B.V. | 2013 | — |
| +1 | K181177 | Interventional Workspot | Philips Medical Systems Nederland B.V. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 3 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 5 | 0 |
| 2002 | 1 | 0 |
| 2003 | 4 | 0 |
| 2004 | 7 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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? (5)
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 |
|---|---|---|---|
| * | K031836 | Philips Fresco Release 1Summary page 1…0LLZ Legally marketed devices Trade names: Fresco Manufacturer: Philips 510(k) numbers: K031836 -Aug 14, 2003 Trade names: Allura 3D-RA Manufacturer: Philips 510(k) nu… | 2003 |
| * | K040254 | Integris 3D-RA, Release 4.2Summary page 1…K031836 -Aug 14, 2003 Trade names: Allura 3D-RA Manufacturer: Philips 510(k) numbers: K040254 - Feb 19, 2004 Trade names: Allura 3D-CA Manufacturer: Philips 510(k) n… | 2004 |
| * | K042334 | Allura 3D-CA, Release 1Summary page 1…K040254 - Feb 19, 2004 Trade names: Allura 3D-CA Manufacturer: Philips 510(k) numbers: K042334 - Sep 27, 2004 Trade names: Xper CT Manufacturer: Philips 510(k) number… | 2004 |
| * | K060749 | XperctSummary page 1…K042334 - Sep 27, 2004 Trade names: Xper CT Manufacturer: Philips 510(k) numbers: K060749 - Apr 4, 2006 Interventional Workspot Page 17 of 401… | 2006 |
| * | K111245 | Heartnavigator Release 1Summary page 2…Page 17 of 401 Trade names: HeartNavigator Release 1 Manufacturer: Philips 51 0(k) numbers: K1 11245 - Jul 29, 20 Device description The Interventional Workspot software medical device is a software platform for host… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181177 | Interventional Workspot | 2018 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 6 companies; a new generation was cleared every 1.4 years on median.
- 24 of the 52 ancestors have a recall of any class.
- Of its descendants, K181177 (Philips Medical Systems Nederland B.V., 2018) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K031836.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
1.1 Device Description The interventional workspot is a software platform to host Interventional Tools. It provides common functionalities (e.g. import / export and data handling functions) that are required by the Interventional Tools to support the physician with performing the interventional procedure. 1.2 Medical Purpose The Interventional Workspot has the following medical purpose: - import, export, and store digital clinical images. - manage the…
Read the full statement (127 words)
1.1 Device Description
The interventional workspot is a software platform to host Interventional Tools. It provides common functionalities (e.g. import / export and data handling functions) that are required by the Interventional Tools to support the physician with performing the interventional procedure.
1.2 Medical Purpose
The Interventional Workspot has the following medical purpose:
- import, export, and store digital clinical images.
- manage the patient information associated with those images:
1.3 Patient Population
Not applicable because Interventional Workspot is only a hosting platform.
1.4 Intended Operator Profile
The operator of Interventional Workspot has basic understanding of the operating principle of medical computer software.
1.5 Clinical Environment
The software can be used in the control room and in the exam room of an interventional suite and/or operating room.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121296 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121296: Interventional Workspot.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121296
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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