免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料，僅供一般參考，不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

Sirius MRI 標記，內含 Sirius MRI 標記的 Cs-131 預裝纖維，以 18 觀針製成

K 號：K202267 · 2020-12-31

申請人Isoray Medical, Inc.
決定日期2020-12-31
產品代碼KXK
諮詢委員會RA
決定相當於

器材摘要

Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles is the device name listed in this FDA 510(k) record. The listed applicant is Isoray Medical, Inc.. It received FDA 510(k) clearance on 2020-12-31 under 510(k) number K202267. The device is classified under product code KXK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles?

Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles is a medical device that received FDA 510(k) clearance on 2020-12-31. The listed applicant is Isoray Medical, Inc.. The 510(k) number is K202267.

When did Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles receive FDA 510(k) clearance?

Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles received FDA 510(k) clearance on 2020-12-31, under 510(k) number K202267.

Who is the listed applicant for Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles?

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

What is the FDA product code for Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles?

The FDA product code for Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles is KXK.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Isoray 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。

K180515伽馬Tile

相關器械（代碼：KXK）

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。

K252296OncoPatchOncopatch, Inc.K242818IsoSphereIsoaid, LLCK223465RadianceTx 放射性同位素近端放射治療源Radiance Therapeutics, Inc.K221539伽馬TileGt Medical TechnologiesK193602LV Liberty Vision 模型 1 90釔近端放射源Lv Liberty Vision CorporationK190839伽馬TileGt Medical Technologies

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。

↑