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FDA 510(k)

Garion Image-Intensified Fluoroscopic X-Ray System, Mobile

K-Number: K222080 · 2022-10-06

ApplicantSg Healthcare Co, Ltd.
Decision Date2022-10-06
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Garion Image-Intensified Fluoroscopic X-Ray System, Mobile is the device name listed in this FDA 510(k) record. The listed applicant is Sg Healthcare Co, Ltd.. It received FDA 510(k) clearance on 2022-10-06 under 510(k) number K222080. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Garion Image-Intensified Fluoroscopic X-Ray System, Mobile?

Garion Image-Intensified Fluoroscopic X-Ray System, Mobile is a medical device that received FDA 510(k) clearance on 2022-10-06. The listed applicant is Sg Healthcare Co, Ltd.. The 510(k) number is K222080.

When did Garion Image-Intensified Fluoroscopic X-Ray System, Mobile receive FDA 510(k) clearance?

Garion Image-Intensified Fluoroscopic X-Ray System, Mobile received FDA 510(k) clearance on 2022-10-06, under 510(k) number K222080.

Who is the listed applicant for Garion Image-Intensified Fluoroscopic X-Ray System, Mobile?

The FDA 510(k) record lists Sg Healthcare Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Garion Image-Intensified Fluoroscopic X-Ray System, Mobile?

The FDA product code for Garion Image-Intensified Fluoroscopic X-Ray System, Mobile is OWB.

Other records listing Sg Healthcare Co, 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.

K230241Jumong General

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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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