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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 a medical device manufactured by Ecoray Co., Ltd.. It received FDA 510(k) clearance on 2025-04-18 under approval 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. It is manufactured by Ecoray Co., Ltd.. The 510(k) number is K241996.

When was ULTRA 1040 approved by the FDA?

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

What company makes ULTRA 1040?

ULTRA 1040 is manufactured by Ecoray Co., Ltd..

What is the FDA product code for ULTRA 1040?

The FDA product code for ULTRA 1040 is IZL.

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Official Source

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