Cleared Traditional

PodSKAN HF Diagnostic X-ray System

K231761 · Skanray Technologies Limited · Radiology

Oct 2023

Decision

133d

Days

Class 2

Risk

About This 510(k) Submission

K231761 is an FDA 510(k) clearance for the PodSKAN HF Diagnostic X-ray System, a System, X-ray, Stationary (Class II — Special Controls, product code KPR), submitted by Skanray Technologies Limited (Mysore, IN). The FDA issued a Cleared decision on October 27, 2023, 133 days after receiving the submission on June 16, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number	K231761 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 16, 2023
Decision Date	October 27, 2023
Days to Decision	133 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF