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FDA 510(k)

PodSKAN HF Diagnostic X-ray System

K-Number: K231761 · 2023-10-27

ApplicantSkanray Technologies Limited
Decision Date2023-10-27
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PodSKAN HF Diagnostic X-ray System is a medical device manufactured by Skanray Technologies Limited. It received FDA 510(k) clearance on 2023-10-27 under approval number K231761. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PodSKAN HF Diagnostic X-ray System?

PodSKAN HF Diagnostic X-ray System is a medical device that received FDA 510(k) clearance on 2023-10-27. It is manufactured by Skanray Technologies Limited. The 510(k) number is K231761.

When was PodSKAN HF Diagnostic X-ray System approved by the FDA?

PodSKAN HF Diagnostic X-ray System received FDA 510(k) clearance on 2023-10-27, under approval number K231761.

What company makes PodSKAN HF Diagnostic X-ray System?

PodSKAN HF Diagnostic X-ray System is manufactured by Skanray Technologies Limited.

What is the FDA product code for PodSKAN HF Diagnostic X-ray System?

The FDA product code for PodSKAN HF Diagnostic X-ray System is KPR.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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