MEDCHECK許可證索引
衛部醫器輸字
許可證編號032067
許可證編號032067
輸入器材
醫療器材許可證 ／ 輸入器材
“飛利浦”心血管X光系統
“Philips” Azurion Series X-ray System
衛部醫器輸字第032067號
本站收錄狀態核准有效
有效日期2029 / 01 / 10
醫療器材級數第二等級
申請商為 台灣飛利浦股份有限公司，收錄 31 個 UDI 型號。 以下整理許可證、規格與製造廠資料，供核對產品身分使用。
許可證資料 依公開資料欄位整理
- 許可證字號
- 衛部醫器輸字第032067號
- 申請商
- 台灣飛利浦股份有限公司 （查看此申請商全部許可證）
- 統一編號
- 11916803
- 申請商地址
- 臺北市信義區市民大道6段288號10樓之6
- 發證日期
- 2019 / 01 / 10
- 有效日期
- 2029 / 01 / 10
- 限制項目
- 輸 入、輸入須附同意書（每次輸入均須取得原子能委員會之同意書為憑）
- 資料異動日期
- 2023 / 09 / 04
這類器材是什麼 X光血管攝影系統，AI 輔助整理
X光血管攝影系統是一台大型的X光影像設備，會即時拍下血管裡的顯影劑流動，讓醫師看清楚血管的走向和狹窄、阻塞的位置。它通常裝在醫院的心導管室或手術室裡。
它跟一般X光機差在哪
一般X光機拍的是靜態的一張影像，像胸腔X光。血管攝影系統要連續拍攝、把顯影劑流過血管的過程記錄下來，所以需要能快速變換角度、即時顯像的設計。
- 會從不同角度取像，方便判斷血管的立體走向。
- 搭配注射顯影劑，才看得見血管腔。
- 有些機型是懸吊式或落地式，差在X光管球怎麼移動、怎麼貼近病人。
- 部分機型可做術中螢光影像，在手術中輔助確認血流。
誰會用到它
- 心導管檢查與治療，例如冠狀動脈攝影、放支架。
- 周邊血管的檢查與介入治療。
- 腦血管、肝臟等部位的血管攝影。
- 部分外科手術中，用來確認血管接合或血流狀況。
為什麼許可證這麼少
這類設備是整台機器，不是耗材，一家醫院買一台就用很多年，所以全台有效的許可證只有 32 張。其中 30 張是進口，國內製造 2 張；製造廠以德國 15 張最多，其次日本、法國、荷蘭。全部都是第 2 等級。
民眾要確認什麼
這類設備是由醫療院所採購、由受過訓練的放射師與醫師操作，民眾不會自己買。如果想知道醫院用的設備是否合法，可以看機器上的醫療器材許可證字號，再到本站查詢。
常見問題
X光血管攝影系統是什麼？
它是一台大型X光設備，能在注射顯影劑後連續拍攝血管影像，讓醫師看到血管的走向、狹窄或阻塞。常裝在心導管室或手術室，用來做心導管、周邊血管等檢查與治療。
血管攝影和電腦斷層血管攝影有什麼差別？
兩者都能看血管，但方式不同。血管攝影是把導管放進血管、直接注射顯影劑，影像即時且解析度高，還能在同一時間做治療。電腦斷層血管攝影是從靜脈打顯影劑再掃描，屬非侵入性檢查，通常用來初步評估。
做血管攝影會痛嗎？
打顯影劑時身體可能一陣發熱，穿刺部位會先局部麻醉，多數人不會覺得劇痛。實際感受因人而異，檢查前醫師會說明流程和可能的風險，有疑慮可以直接問。
X光血管攝影系統有輻射嗎？
有，它用X光成像，檢查過程會接觸輻射。醫療團隊會用最短的曝露時間和適當的防護來降低劑量。孕婦或可能懷孕的人，檢查前一定要先告知醫師。
本段由 AI 依官方分類輔助整理，僅供認識器材之用，不構成醫療建議。使用前請以醫師指示與產品仿單為準。
UDI 標示 依 UDI 資料彙整
- 單次使用是
- 滅菌包裝是
- 天然橡膠（乳膠）不含
- DEHP不含
- 批號有
- 序號有
- 製造日期有
- 有效期限有
- 健保特材未填
這張許可證底下有多個型號時，只要其中一款有標示，就顯示為「是」或「有」。
效能與規格
- 效能
- 詳如中文仿單核定本
- 規格
- Azurion 3 M12、Azurion 3M15、Azurion 7 M12、Azurion 7 M20、Azurion 7 B12、Azurion 7 B20，以下空白。
規格變更：詳如中文仿單核定本(原108年1月25日核定之仿單標籤核定本收回作廢)。
規格變更：詳如核定之中文說明書(原109年6月17日核定之標籤、說明書或包裝予以收回作廢)。
增加規格：Azurion 5 M12、Azurion 5 M20。
製造廠
- 製造商
- Philips Medical Systems Nederland B.V.
- 國別
- 荷蘭
- 廠址
- Veenpluis 6, 5684 PC Best, The Netherlands
- 製造許可登錄編號
- QSD5478
UDI 型號 共 31 筆
| 基本 DI | 型號 | 產品描述 | 單次使用 | 乳膠 | DEHP |
|---|---|---|---|---|---|
| 00884838059184 | 000071 | EP navigator, Software medical device, used with a Philips Interventional X-Ray System. Provides navigation support for cardiovascular devices for heart rhythm disorders. | 否 | 否 | 否 |
| 00884838059221 | 001003 | 3D Roadmap, Software medical device, used with a Philips Interventional X-Ray System. Extension of 3D-RA. Superimposes live fluoroscopic images on a 3D reconstruction of the vessel anatomy. | 否 | 否 | 否 |
| 00884838059238 | 001004 | MR-CT Roadmap, Software medical device, used with a Philips Interventional X-Ray System. Extension of 3D-RA. Provides live 3D image guidance for navigating endovascular devices through vascular structures. | 否 | 否 | 否 |
| 00884838059252 | 001006 | XperGuide, Software medical device, used with a Philips Interventional X-Ray System. Extension of XperCT. Intended to assist the user during percutaneous interventions by providing live 3D needle image guidance. | 否 | 否 | 否 |
| 00884838059269 | 001007 | StentBoost, Software medical device, used with a Philips Interventional X-Ray System. Provides high resolution visualization of stents in vessels. Supports the user in placing and deploying stents. | 否 | 否 | 否 |
| 00884838059276 | 001008 | 2D Perfusion, Software medical device, used with a Philips Interventional X-Ray System. Provides a color coded representation of a digital subtraction angiography (DSA). | 否 | 否 | 否 |
| 00884838059290 | 001012 | EmboGuide, Software medical device, used with a Philips Interventional X-Ray System. Extension of XperCT. Assists physicians with embolization of hypervascular tumors in the liver using interventional X-ray. | 否 | 否 | 否 |
| 00884838059306 | 001105 | XperCT Dual, Software medical device, used with a Philips Interventional X-Ray System. Reconstructs 3D volumes from rotational fluoroscopic acquisitions and provides CT-like images to assist the physician. | 否 | 否 | 否 |
| 00884838064768 | 001015 | AneurysmFlow, Software medical device, used with a Philips Interventional X-Ray System. Intended to assist with saccular cerebral aneurysm embolization, by visualizing and quantifying blood flow changes. | 否 | 否 | 否 |
| 00884838064775 | 001013 | VesselNavigator , Software medical device, used with a Philips Interventional X-Ray System. Intended to assist in the treatment of endovascular diseases during an endovascular intervention procedure. | 否 | 否 | 否 |
| 00884838080737 | 001011 | EchoNavigator, Software medical device. Supports treatments with live X-ray and live Echo guidance. To be used with compatible Echo-probes and Echo units in combination with a Philips Interventional X-Ray System. | 否 | 否 | 否 |
| 00884838080744 | 001001 | HeartNavigator , Software medical device, used with a Philips Interventional X-Ray System. Assists the user with treatment of structural heart diseases using minimal invasive interventional techniques. | 否 | 否 | 否 |
| 00884838084544 | 002010 | Philips Hemodynamic Application, Software medical device. Intended for use by professional healthcare providers for physiologic/hemodynamic monitoring, medical data processing and analytical assessment. | 否 | 否 | 否 |
| 00884838084766 | 001102 | 3D-RA, Software medical device, used with a Philips Interventional X-Ray System. Creates 3D views of vessels and bones from sets of 2D images from rotational angiographic runs. | 否 | 否 | 否 |
| 00884838085732 | 001018 | SmartCT, Software medical device, used with a Philips Interventional X-Ray System. Assists physicians by providing 3D views of the anatomy combined with planning and live guidance functionality. | 否 | 否 | 否 |
| 00884838088566 | 001119 | SmartPerfusion , Software medical device used with a Philips Interventional X-Ray System. Provides color coded representation of digital subtraction angiography to assist diagnosis of perfusion alterations of tissues. | 否 | 否 | 否 |
| 00884838099203 | 722221 | Azurion 3 M12 Monoplane Interventional X-Ray System. A floor-mounted monoplane system with a 12-inch flat detector. | 否 | 否 | 否 |
| 00884838099241 | 722223 | Azurion 7 M12 Monoplane Interventional X-Ray System. A ceiling or floor-mounted monoplane system with a 12-inch flat detector. | 否 | 否 | 否 |
| 00884838099258 | 722224 | Azurion 7 M20 Monoplane Interventional X-Ray System. A ceiling or floor-mounted monoplane system with a 20-inch flat detector. Optionally the ceiling-mounted configuration has an interface for an OR table | 否 | 否 | 否 |
| 00884838099265 | 722225 | Azurion 7 B12 Biplane Interventional X-Ray System with floor-mounted frontal stand (12-inch flat detector), ceiling-mounted lateral stand (12-inch flat detector) and optional interface for an OR table. | 否 | 否 | 否 |
| 00884838099272 | 722226 | Azurion 7 B20 Biplane Interventional X-Ray System with floor-mounted frontal stand (20-inch flat detector), ceiling-mounted lateral stand (12-inch or 15-inch flat detector) and optional interface for an OR table. | 否 | 否 | 否 |
| 00884838100084 | 830230 | Xper IM.The Information Management System is a software to acquire, display, trend, store and transmit physiologic, hemodynamic, clinical, medical image and other related data. | 否 | 否 | 否 |
| 00884838101883 | 001016 | Dynamic Coronary Roadmap, Software medical device, used with a Philips Interventional X-Ray System. Intended to provide a real-time and dynamic angiographic roadmap of coronary arteries. | 否 | 否 | 否 |
| 00884838101890 | 001017 | StentBoost Live, Software medical device, used with a Philips Interventional X-Ray System. Provides real-time enhanced visualization of stents in coronary vessels. Supports the user in placing and deploying stents. | 否 | 否 | 否 |
| 00884838105034 | 830230 | Xper IM. The Information Management System is a software to acquire, display, trend, store and transmit physiologic, hemodynamic, clinical, medical image and other related data. | 否 | 否 | 否 |
| 00884838106437 | 001011 | EchoNavigator, Software medical device. Supports treatments with live X-ray and live Echo guidance. To be used with compatible Echo-probes and Echo units in combination with a Philips Interventional X-Ray System. | 否 | 否 | 否 |
| 00884838096844 | 45980159392x | ClarifEye Marker | 是 | 否 | 否 |
| 00884838096851 | 45980159390x | ClarifEye Needle | 是 | 否 | 否 |
| 00884838099210 | 722222 | Azurion 3 M15 Monoplane Interventional X-Ray System. A floor-mounted monoplane system with a 15-inch flat detector. | 否 | 否 | 否 |
| 00884838099227 | 722227 | Azurion 5 M12 Monoplane | 否 | 否 | 否 |
找的不是這個型號？
可改用包裝上的完整型號或許可證字號查詢。