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FDA 510(k)

Portable X-ray System

K-Number: K223010 · 2023-01-17

Decision Date2023-01-17
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Portable X-ray System is the device name listed in this FDA 510(k) record. The listed applicant is Iray Technology Taicang , Ltd.. It received FDA 510(k) clearance on 2023-01-17 under 510(k) number K223010. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Portable X-ray System?

Portable X-ray System is a medical device that received FDA 510(k) clearance on 2023-01-17. The listed applicant is Iray Technology Taicang , Ltd.. The 510(k) number is K223010.

When did Portable X-ray System receive FDA 510(k) clearance?

Portable X-ray System received FDA 510(k) clearance on 2023-01-17, under 510(k) number K223010.

Who is the listed applicant for Portable X-ray System?

The FDA 510(k) record lists Iray Technology Taicang , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Portable X-ray System?

The FDA product code for Portable X-ray System is EHD.

Other records listing Iray Technology Taicang , Ltd. 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.

View all 21 devices →

Related Devices (Code: EHD)

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

View on FDA Database →

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