510(k) · Cleared
ClearedPulsera
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems North America Co. · IZL System, X-Ray, Mobile
Cleared on Sep 15, 2006 as substantially equivalent to K042646 (Siemens Medical Systems, Inc., 2004) after a 92-day review. Its family tree reaches back 1 generation to 2004. 15 later devices descend from it.
- Decided
- Sep 15, 2006
- Review
- 92 days
- Class
- Class II
- Product code
- IZL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K042646 (2004). 15 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK042646 DynactSiemens Medical Systems, Inc. · 2004
- This deviceK061685 PulseraPhilips Medical Systems North America Co. · 2006
- Descendant · cites it directly · 14 of its ownK090590 Veradius, Model 718-130Philips Medical Systems North America Co. · 2009
- Descendant · 2 generations on · 12 of its ownK133819 VeradiusPhilips Medical Systems Nederland B.V. · 2014
- Descendant · 3 generations on · 11 of its ownK142708 Veradius UnityPhilips Medical Systems Nethrlands BV · 2014 · Recalled
- Descendant · 4 generations on · 6 of its ownK183040 Zenition 70Philips Medical Systems Nederland B.V. · 2018 · Recalled
- Descendant · 4 generations on · 3 of its ownK230871 Extron 5; Extron 7DRTECH Corporation · 2023
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K090590Veradius, Model 718-130Philips Medical Systems North America Co. · 2009 · cites it directly14descendants
- K133819VeradiusPhilips Medical Systems Nederland B.V. · 2014 · 2 generations on12descendants
- K142708Veradius UnityPhilips Medical Systems Nethrlands BV · 2014 · 3 generations on11descendants
- K183040Zenition 70Philips Medical Systems Nederland B.V. · 2018 · 4 generations on6descendants
- K230871Extron 5; Extron 7DRTECH Corporation · 2023 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K042646 | Dynact | Siemens Medical Systems, Inc. | 2004 | — |
| 0 (this device) | K061685 | Pulsera | Philips Medical Systems North America Co. | 2006 | — |
| +1 | K090590 | Veradius, Model 718-130 | Philips Medical Systems North America Co. | 2009 | — |
| +2 | K133819 | Veradius | Philips Medical Systems Nederland B.V. | 2014 | — |
| +3 | K142708 | Veradius Unity | Philips Medical Systems Nethrlands BV | 2014 | 4 |
| +4 | K183040 | Zenition 70 | Philips Medical Systems Nederland B.V. | 2018 | 5 |
| +4 | K230871 | Extron 5; Extron 7 | DRTECH Corporation | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 2 | 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 IZL? 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 IZL device
- #1 K242015 TOPAZ Mobile X-ray System (Models : TOPAZ-32D…score 19.9 · 19 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K042646 | DynactSummary page 1…5684 PC Best, The Nederlands Predicate Device: The Philips 3D-RX Option for BV Pulsera is substantially equivalent to the Siemens ArcadisOrbic 3D (FDA Number K042646). Device Description: The Philips 3D-RX Option for BV Pulsera is a mobile C-Armn X-Ray System offering Radiographic and Fluorosc… | 2004 |
What descends from it? (15)
See all 151 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090590 | Veradius, Model 718-130 | 2009 | 14 |
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?
How does its category compare?
All IZL devicesIZL System, X-Ray, Mobile: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IZL
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IZL
153in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IZL
47in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IZL
27in 2025
MAUDE reports naming product code IZL, 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 | 3 | 30 | 7 | 16 |
| 2008 | 4 | 49 | 0 | 27 |
| 2009 | 3 | 125 | 0 | 35 |
| 2010 | 3 | 65 | 4 | 75 |
| 2011 | 6 | 66 | 6 | 118 |
| 2012 | 3 | 83 | 5 | 24 |
| 2013 | 0 | — | 10 | 17 |
| 2014 | 7 | 104 | 4 | 51 |
| 2015 | 4 | 88 | 4 | 30 |
| 2016 | 6 | 47 | 0 | 33 |
| 2017 | 7 | 45 | 0 | 35 |
| 2018 | 8 | 47 | 0 | 27 |
| 2019 | 9 | 33 | 2 | 40 |
| 2020 | 9 | 43 | 1 | 48 |
| 2021 | 13 | 48 | 0 | 47 |
| 2022 | 16 | 89 | 1 | 32 |
| 2023 | 3 | 55 | 6 | 77 |
| 2024 | 9 | 159 | 5 | 39 |
| 2025 | 11 | 153 | 47 | 27 |
| 2026 | 6 | 157 | 5 | — |
What is it indicated for?
The 3D-RX Option on the BV Pulsera provides 3D imaging functionality and is intended to be used whenever the physician benefits from intra-operatively-generated 3D information of high contrast objects and anatomical structures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061685 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061685: Pulsera.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061685
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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