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FDA 510(k)

Small Field Applicator

K-Number: K220883 · 2022-12-15

ApplicantHitachi, Ltd. Radiation Oncology Systems, Kashiwanoha
Decision Date2022-12-15
Product CodeLHN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Small Field Applicator is a medical device manufactured by Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha. It received FDA 510(k) clearance on 2022-12-15 under approval number K220883. The device is classified under product code LHN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Small Field Applicator?

Small Field Applicator is a medical device that received FDA 510(k) clearance on 2022-12-15. It is manufactured by Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha. The 510(k) number is K220883.

When was Small Field Applicator approved by the FDA?

Small Field Applicator received FDA 510(k) clearance on 2022-12-15, under approval number K220883.

What company makes Small Field Applicator?

Small Field Applicator is manufactured by Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha.

What is the FDA product code for Small Field Applicator?

The FDA product code for Small Field Applicator is LHN.

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Other Devices by Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha

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Official Source

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