FDA 510(k)

伽馬Tile

K 號：K190296 · 2019-03-13

決定日期2019-03-13

產品代碼KXK

諮詢委員會RA

決定相當於

器材摘要

GammaTile is the device name listed in this FDA 510(k) record. The listed applicant is Gt Medical Technologies. It received FDA 510(k) clearance on 2019-03-13 under 510(k) number K190296. 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 GammaTile?

GammaTile is a medical device that received FDA 510(k) clearance on 2019-03-13. The listed applicant is Gt Medical Technologies. The 510(k) number is K190296.

When did GammaTile receive FDA 510(k) clearance?

GammaTile received FDA 510(k) clearance on 2019-03-13, under 510(k) number K190296.

Who is the listed applicant for GammaTile?

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

What is the FDA product code for GammaTile?

The FDA product code for GammaTile is KXK.

其他以 Gt Medical Technologies 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。

K221539伽馬Tile K190839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, LLC K223465RadianceTx 放射性同位素近端放射治療源Radiance Therapeutics, Inc.K221539伽馬TileGt Medical Technologies K202267Sirius MRI 標記，內含 Sirius MRI 標記的 Cs-131 預裝纖維，以 18 觀針製成Isoray Medical, Inc.K193602LV Liberty Vision 模型 1 90釔近端放射源Lv Liberty Vision Corporation

官方來源

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