Skan C Pulsar
FDA 510(k) K251893 · Skanray Technologies Limited
510(k) numberK251893
Submission
- Device name
- Skan C Pulsar
- Applicant
- Skanray Technologies Limited
Mysore, IN - Received
- June 20, 2025
- Decision date
- December 16, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K253726 | uAngio AVIVA CXOWB · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 08/21/2026SE |
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| K252503 | Intelligent NROWB · Traditional | Canon, Inc. | 04/30/2026SE |
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| K252229 | Belliger AceOWB · Traditional | Genoray Co., Ltd. | 04/02/2026SE |
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| K231761 | PodSKAN HF Diagnostic X-ray SystemKPR · Traditional | 10/27/2023SE |
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| K212940 | Skanmobile, Skanmobile-DrIZL · Traditional | 03/04/2022SE |
| K172147 | Star 65MWI · Traditional | 05/25/2018SE |
| K150512 | Star 90MWI · Traditional | 06/17/2015SE |
| K111330 | Air Techniques High Frequency Intra-Oral X-RayEHD · Traditional | 05/27/2011SE |
| K103579 | Intra Skan DCEHD · Traditional | 03/18/2011SE |
Questions and answers
When was Skan C Pulsar cleared by the FDA?
Skan C Pulsar (K251893) received a 510(k) decision of Substantially Equivalent on December 16, 2025, 179 days after the submission was received.
What is the product code of K251893?
The FDA product code is OWB – Interventional Fluoroscopic X-Ray System, a Class II (moderate risk) device regulated under 21 CFR 892.1650.