Auto-Seg (SO-0012)，脊柱自動分段（SO-0012）
K 號：K253628 · 2026-06-29
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器材摘要
Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012) is the device name listed in this FDA 510(k) record. The listed applicant is Agada Medical, Ltd.. It received FDA 510(k) clearance on 2026-06-29 under 510(k) number K253628. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012)?
Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012) is a medical device that received FDA 510(k) clearance on 2026-06-29. The listed applicant is Agada Medical, Ltd.. The 510(k) number is K253628.
When did Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012) receive FDA 510(k) clearance?
Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012) received FDA 510(k) clearance on 2026-06-29, under 510(k) number K253628.
Who is the listed applicant for Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012)?
The FDA 510(k) record lists Agada Medical, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012)?
The FDA product code for Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012) is QIH.
相關臨床試驗
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相關器械（代碼：QIH）
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。
官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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