FDA 510(k)

S250-FIT プロトン線放射線治療装置（S250-FIT）

K番号: K253406 · 2026-03-25

決定日2026-03-25

製品コードLHN

諮問委員会RA （注：由于原文中未提供具体的医疗设备监管文本内容，因此无法进行翻译。请提供具体的文本内容以便进行翻译。）

決定大幅同等

医療機器の概要

S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) is the device name listed in this FDA 510(k) record. The listed applicant is Mevion Medical Systems, Inc.. It received FDA 510(k) clearance on 2026-03-25 under 510(k) number K253406. The device is classified under product code LHN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)?

S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) is a medical device that received FDA 510(k) clearance on 2026-03-25. The listed applicant is Mevion Medical Systems, Inc.. The 510(k) number is K253406.

When did S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) receive FDA 510(k) clearance?

S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) received FDA 510(k) clearance on 2026-03-25, under 510(k) number K253406.

Who is the listed applicant for S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)?

The FDA 510(k) record lists Mevion Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)?

The FDA product code for S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) is LHN.

申請者としてMevion Medical Systems, Inc.を記載するその他の記録

K250986S250-FIT プロトン線放射線治療装置（S250-FIT）

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