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FDA 510(k)

RCT800

K-Number: K260462 · 2026-04-09

ApplicantRay Co., Ltd.
Decision Date2026-04-09
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RCT800 is the device name listed in this FDA 510(k) record. The listed applicant is Ray Co., Ltd.. It received FDA 510(k) clearance on 2026-04-09 under 510(k) number K260462. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RCT800?

RCT800 is a medical device that received FDA 510(k) clearance on 2026-04-09. The listed applicant is Ray Co., Ltd.. The 510(k) number is K260462.

When did RCT800 receive FDA 510(k) clearance?

RCT800 received FDA 510(k) clearance on 2026-04-09, under 510(k) number K260462.

Who is the listed applicant for RCT800?

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

What is the FDA product code for RCT800?

The FDA product code for RCT800 is OAS.

Other records listing Ray 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.

View all 17 devices →

Related Devices (Code: OAS)

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.