FDA 510(k)

SPRY TMS治療系統（0550）

K 號：K251653 · 2026-02-20

決定日期2026-02-20

產品代碼OBP

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

SPRY TMS Therapy System (0550) is the device name listed in this FDA 510(k) record. The listed applicant is Soterix Medical, Inc.. It received FDA 510(k) clearance on 2026-02-20 under 510(k) number K251653. The device is classified under product code OBP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SPRY TMS Therapy System (0550)?

SPRY TMS Therapy System (0550) is a medical device that received FDA 510(k) clearance on 2026-02-20. The listed applicant is Soterix Medical, Inc.. The 510(k) number is K251653.

When did SPRY TMS Therapy System (0550) receive FDA 510(k) clearance?

SPRY TMS Therapy System (0550) received FDA 510(k) clearance on 2026-02-20, under 510(k) number K251653.

Who is the listed applicant for SPRY TMS Therapy System (0550)?

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

What is the FDA product code for SPRY TMS Therapy System (0550)?

The FDA product code for SPRY TMS Therapy System (0550) is OBP.

其他以 Soterix Medical, Inc. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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相關器械（代碼：OBP）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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