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FDA 510(k)

Klarity SGRT System (ARSG-E1A, ARSG-E3A)

K-Number: K241937 · 2025-03-18

ApplicantKlarity Medical & Equipment (GZ) Co., Ltd.
Decision Date2025-03-18
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Klarity SGRT System (ARSG-E1A, ARSG-E3A) is the device name listed in this FDA 510(k) record. The listed applicant is Klarity Medical & Equipment (GZ) Co., Ltd.. It received FDA 510(k) clearance on 2025-03-18 under 510(k) number K241937. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Klarity SGRT System (ARSG-E1A, ARSG-E3A)?

Klarity SGRT System (ARSG-E1A, ARSG-E3A) is a medical device that received FDA 510(k) clearance on 2025-03-18. The listed applicant is Klarity Medical & Equipment (GZ) Co., Ltd.. The 510(k) number is K241937.

When did Klarity SGRT System (ARSG-E1A, ARSG-E3A) receive FDA 510(k) clearance?

Klarity SGRT System (ARSG-E1A, ARSG-E3A) received FDA 510(k) clearance on 2025-03-18, under 510(k) number K241937.

Who is the listed applicant for Klarity SGRT System (ARSG-E1A, ARSG-E3A)?

The FDA 510(k) record lists Klarity Medical & Equipment (GZ) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Klarity SGRT System (ARSG-E1A, ARSG-E3A)?

The FDA product code for Klarity SGRT System (ARSG-E1A, ARSG-E3A) is IYE.

Other records listing Klarity Medical & Equipment (GZ) 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.

K220539Klarity SRS Baseplate, Klarity Promise BaseplateK202747Klarity Bolus

Related Devices (Code: IYE)

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.

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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.

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