Cleared Traditional

SKAN C PULSAR

K251893 · Skanray Technologies Limited · Radiology

Dec 2025

Decision

179d

Days

Class 2

Risk

About This 510(k) Submission

K251893 is an FDA 510(k) clearance for the SKAN C PULSAR, a Interventional Fluoroscopic X-ray System (Class II — Special Controls, product code OWB), submitted by Skanray Technologies Limited (Mysore, IN). The FDA issued a Cleared decision on December 16, 2025, 179 days after receiving the submission on June 20, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number	K251893 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 20, 2025
Decision Date	December 16, 2025
Days to Decision	179 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF

Device Classification

Product Code	OWB — Interventional Fluoroscopic X-ray System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 892.1650
Definition	Interventional Fluoroscopy