510(k) · Cleared
ClearedSkan C Pulsar
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Skanray Technologies Limited · OWB Interventional Fluoroscopic X-Ray System
Cleared on Dec 16, 2025 as substantially equivalent to K230871 (DRTECH Corporation, 2023) and 1 other predicate after a 179-day review. Its family tree reaches back 6 generations to 2004.
- Decided
- Dec 16, 2025
- Review
- 179 days
- Class
- Class II
- Product code
- OWB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K042646 (2004). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK042646 DynactSiemens Medical Systems, Inc. · 2004
- 5 generations backK061685 PulseraPhilips Medical Systems North America Co. · 2006
- 4 generations backK090590 Veradius, Model 718-130Philips Medical Systems North America Co. · 2009
- 3 generations backK133819 VeradiusPhilips Medical Systems Nederland B.V. · 2014
- 2 generations backK142708 Veradius UnityPhilips Medical Systems Nethrlands BV · 2014 · Recalled
- 1 generation backK230871 Extron 5; Extron 7DRTECH Corporation · 2023
- This deviceK251893 Skan C PulsarSkanray Technologies Limited · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K042646 | Dynact | Siemens Medical Systems, Inc. | 2004 | — |
| −5 | K061685 | Pulsera | Philips Medical Systems North America Co. | 2006 | — |
| −4 | K090590 | Veradius, Model 718-130 | Philips Medical Systems North America Co. | 2009 | — |
| −3 | K133819 | Veradius | Philips Medical Systems Nederland B.V. | 2014 | — |
| −2 | K142708 | Veradius Unity | Philips Medical Systems Nethrlands BV | 2014 | 4 |
| −1 | K230871 | Extron 5; Extron 7 | DRTECH Corporation | 2023 | — |
| 0 (this device) | K251893 | Skan C Pulsar | Skanray Technologies Limited | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2017 | 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 OWB? 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 OWB device
- #1 K251602 Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6…score 18.3 · 18 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 |
|---|---|---|---|
| * | K230871 | Extron 5; Extron 7Summary page 6…1 Subsequent product OXO, JAA code Primary Predicate Extron 5, Extron 7 device 510(k) Clearance: K230871 Device class: II Device common name: Interventional Fluoroscopic X-Ray System… | 2023 |
| * | K170946 | Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm X-Ray System - 110V…Summary page 6…e C-arm X-Ray System – 230V Variant (3030-000187-1), Skan C Mobile X-Ray system – 110V Variant Predicate device (3030-00187-2) 510(k) Clearance: K170946 Device class: II Device common name: Image Intensified Fluoroscopic X-Ray System… | 2017 |
| † | K200218 | Digiscan FDX | 2020 |
| † | K181560 | Cios Alpha | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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 21 years and passes through 6 companies; a new generation was cleared every 2.5 years on median.
- 2 of the 8 ancestors have a recall of any class.
- 1 other device also cites its predicate K230871.
How does its category compare?
All OWB devicesOWB Interventional Fluoroscopic X-Ray System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · OWB
22in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OWB
148in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWB
42so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OWB
14,008in 2025
MAUDE reports naming product code OWB, 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 | 52 | 0 | 1 |
| 2008 | 4 | 135 | 1 | 0 |
| 2009 | 9 | 99 | 0 | 0 |
| 2010 | 7 | 66 | 0 | 0 |
| 2011 | 6 | 79 | 0 | 1 |
| 2012 | 6 | 37 | 0 | 1 |
| 2013 | 11 | 119 | 10 | 27 |
| 2014 | 15 | 158 | 9 | 103 |
| 2015 | 11 | 66 | 35 | 2,134 |
| 2016 | 16 | 103 | 13 | 4,074 |
| 2017 | 20 | 76 | 13 | 1,604 |
| 2018 | 23 | 54 | 6 | 1,449 |
| 2019 | 9 | 174 | 7 | 1,558 |
| 2020 | 16 | 53 | 8 | 1,581 |
| 2021 | 24 | 60 | 31 | 1,981 |
| 2022 | 21 | 90 | 24 | 2,932 |
| 2023 | 12 | 152 | 22 | 7,604 |
| 2024 | 13 | 126 | 11 | 7,942 |
| 2025 | 22 | 148 | 30 | 14,008 |
| 2026 | 15 | 221 | 42 | — |
What is it indicated for?
The SKAN C Pulsar, a Mobile Surgical C-Arm X-Ray System, is intended to provide Fluoroscopic images of patients during Diagnostic, Surgical and Interventional procedures. SKAN C Pulsar is to be used by adequately trained, qualified and authorized healthcare professionals. Clinical Applications may include Orthopedic, GI Procedure, Neurology, Urology Procedures, Vascular in Critical Care and Emergency Room Procedures.
SKAN C Pulsar is not recommended for Cardiac Applications.
SKAN C Pulsar surgical C-Arm is indicated for visualization in real time and/or recording of surgical region of interest and anatomy, using X-ray imaging technique.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251893 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251893: Skan C Pulsar.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251893
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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