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FDA 510(k)

PodSKAN HF Diagnostic X-ray System

K-Number: K231761 · 2023-10-27

Decision Date2023-10-27
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PodSKAN HF Diagnostic X-ray System is the device name listed in this FDA 510(k) record. The listed applicant is Skanray Technologies Limited. It received FDA 510(k) clearance on 2023-10-27 under 510(k) 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. The listed applicant is Skanray Technologies Limited. The 510(k) number is K231761.

When did PodSKAN HF Diagnostic X-ray System receive FDA 510(k) clearance?

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

Who is the listed applicant for PodSKAN HF Diagnostic X-ray System?

The FDA 510(k) record lists Skanray Technologies Limited as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Skanray Technologies Limited as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: KPR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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