VirtuOst脊椎骨折評估
K 號：K171435 · 2018-08-03
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器材摘要
VirtuOst Vertebral Fracture Assessment is the device name listed in this FDA 510(k) record. The listed applicant is O.N. Diagnostics, LLC. It received FDA 510(k) clearance on 2018-08-03 under 510(k) number K171435. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the VirtuOst Vertebral Fracture Assessment?
VirtuOst Vertebral Fracture Assessment is a medical device that received FDA 510(k) clearance on 2018-08-03. The listed applicant is O.N. Diagnostics, LLC. The 510(k) number is K171435.
When did VirtuOst Vertebral Fracture Assessment receive FDA 510(k) clearance?
VirtuOst Vertebral Fracture Assessment received FDA 510(k) clearance on 2018-08-03, under 510(k) number K171435.
Who is the listed applicant for VirtuOst Vertebral Fracture Assessment?
The FDA 510(k) record lists O.N. Diagnostics, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for VirtuOst Vertebral Fracture Assessment?
The FDA product code for VirtuOst Vertebral Fracture Assessment is LLZ.
相關臨床試驗
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相關器械（代碼：LLZ）
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
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