510(k) · Cleared
ClearedSkan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm X-Ray System - 110V Variant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Skanray Technologies Private Limited · OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
Cleared on Nov 24, 2017 as substantially equivalent to K043076 (Ge Oec Medical Systems, Inc., 2004) after a 239-day review. Its family tree reaches back 1 generation to 2004. 1 later device descends from it.
- Decided
- Nov 24, 2017
- Review
- 239 days
- Class
- Class II
- Product code
- OXO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K043076 (2004). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK043076 GE Oec FluorostarGe Oec Medical Systems, Inc. · 2004 · Recalled
- This deviceK170946 Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm…Skanray Technologies Private Limited · 2017
- Descendant · cites it directly · 0 of its ownK251893 Skan C PulsarSkanray Technologies Limited · 2025
Most influential descendants
Showing 1 of 1 · See all- K251893Skan C PulsarSkanray Technologies Limited · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K043076 | GE Oec Fluorostar | Ge Oec Medical Systems, Inc. | 2004 | 1 |
| 0 (this device) | K170946 | Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm X-Ray… | Skanray Technologies Private Limited | 2017 | — |
| +1 | K251893 | Skan C Pulsar | Skanray Technologies Limited | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 OXO? 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 OXO device
- #1 K253296 Digital C-ARM with 3Dscore 15.1 · 13 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 |
|---|---|---|---|
| * | K043076 | GE Oec FluorostarSummary page 4…892.1650 Product Code: OXO -Primary & OWB-Secondary 5.4. Predicate Device GE OEC Fluorostar – K043076 Regulation Name: Image-intensified fluoroscopic x-ray system Regulation number:… | 2004 |
| † | K091918 | Zen-2090 Pro, Fluoroscopic X-Ray System, Model Zen-2090 Pro | 2009 |
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 |
|---|---|---|---|
| K251893 | Skan C Pulsar | 2025 | 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?
How does its category compare?
All OXO devicesOXO Image-Intensified Fluoroscopic X-Ray System, Mobile: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · OXO
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OXO
97in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OXO
4in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OXO
118in 2025
MAUDE reports naming product code OXO, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 4 | 48 | 4 | 5 |
| 2013 | 2 | — | 3 | 41 |
| 2014 | 2 | — | 4 | 89 |
| 2015 | 1 | — | 0 | 97 |
| 2016 | 3 | 128 | 3 | 3,820 |
| 2017 | 4 | 57 | 4 | 1,697 |
| 2018 | 1 | — | 11 | 1,647 |
| 2019 | 3 | 213 | 0 | 1,297 |
| 2020 | 0 | — | 0 | 816 |
| 2021 | 2 | — | 0 | 554 |
| 2022 | 0 | — | 0 | 295 |
| 2023 | 0 | — | 0 | 275 |
| 2024 | 2 | — | 4 | 192 |
| 2025 | 4 | 97 | 0 | 118 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The Skan-C, a Mobile Surgical C-Arm X-Ray System, is intended to provide Fluoroscopic and Radiographic images of the patient during Diagnostic, Surgical and Interventional procedures.
Examples of Clinical Applications may include Orthopaedic, GI Procedure like Endoscopy and Cholenography, Neurology, Urology Procedures, Vascular, Critical Care and Emergency Room Procedures.
Skan-C is not recommended for Cardiac Applications.
Skan-C 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/K170946 · printed Nov 5, 2026
Cite this page
510(k) Report. “K170946: Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm X-Ray System - 110V Variant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K170946
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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