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FDA 510(k)

ULTRA 1040

K-Number: K241996 · 2025-04-18

ApplicantEcoray Co., Ltd.
Decision Date2025-04-18
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ULTRA 1040 is the device name listed in this FDA 510(k) record. The listed applicant is Ecoray Co., Ltd.. It received FDA 510(k) clearance on 2025-04-18 under 510(k) number K241996. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRA 1040?

ULTRA 1040 is a medical device that received FDA 510(k) clearance on 2025-04-18. The listed applicant is Ecoray Co., Ltd.. The 510(k) number is K241996.

When did ULTRA 1040 receive FDA 510(k) clearance?

ULTRA 1040 received FDA 510(k) clearance on 2025-04-18, under 510(k) number K241996.

Who is the listed applicant for ULTRA 1040?

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

What is the FDA product code for ULTRA 1040?

The FDA product code for ULTRA 1040 is IZL.

Related Devices (Code: IZL)

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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