OAS

X-Ray, Tomography, Computed, Dental

产品代码
OAS
器械名称
X-Ray, Tomography, Computed, Dental
管理类别
第 2 类(Class II)
21 CFR 条款
21 CFR 892.1750
FDA 专业组
Radiology
上市路径
需提交 510(k) 上市前通告
该代码近三年的 510(k)
24 件
其中 Summary 已存档
22 份,可直接下载
FDA 历史累计 510(k)
135 件(全部年份;本站只收录近三年的明细)

FDA 分类定义

Produce cross-sectional diagnostic x-ray images of the intra-oral tissue and teeth.

定义原文来自 FDA 器械分类库,属美国联邦政府作品(公有领域)。

该代码近三年的 510(k)(24 件)

数据窗口为最近三年。最新一件:2026-07-23。

510(k) 号批准日期申请人器械名称摘要
K2617482026-07-23Hefei Meyer Optoelectronic Technology,Dental Cone-beam Computed Tomography (mDX-15P SeriesPDF
K2508392026-06-11Changzhou Boen Zhongding Medical TechnDental X-ray SystemPDF
K2606622026-06-04Yofo Medical Technology Co., Ltd.Dental Cone Beam Computed Tomography SystemPDF
K2539352026-05-15medXion Technologies, Inc.medXion NEXUSPDF
K2604622026-04-09Ray Co., Ltd.RCT800PDF
K2600932026-03-31VATECH Co., Ltd.Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)PDF
K2523532026-03-10Cefla S.C.myray ProXIma X6PDF
K2539592026-02-05Dentsply SironaPrimevision 3DPDF
K2517982025-11-25Ray Co., Ltd.RCT700PDF
K2518422025-11-13Fussen Technology Co., Ltd.Dental Computed Tomography X-ray SystemPDF
K2500602025-10-08Genoray Co., Ltd.GT300; GT300-CPDF
K2516422025-06-27Yian Medical Technology (Haining) Co.,Dental CBCT X-ray SystemPDF
K2433372025-04-17Yofo Medical Technology Co., Ltd.Dental Cone Beam Computed Tomography SystemPDF
K2439032025-03-12Ray Co., Ltd.RCT600PDF
K2430882025-02-21VATECH Co., Ltd.Green X 12 SE (PHT-40CHS)PDF
K2430812025-02-14VATECH Co., Ltd.Green X 21 (PHT-90CHO)PDF
K2428052025-01-09Changzhou Finno Medical Technology Co.Dental Cone-beam Computed Tomography (FinScan F350)PDF
K2412492024-09-12Palodex Group OYOrthopantomograph™ OP 3D LX (PAN 3D); OrthopantomogrPDF
K2338062024-09-06Osstem Implant Co., Ltd.T2 PlusPDF
K2408552024-04-25Yian Medical Technology (Haining) Co.,Dental Cone-beam Computed TomographyPDF
K2327102024-01-09Yian Medical Technology (Haining) Co.,Dental Cone-beam Computed TomographyFDA
K2309852023-12-28Planmeca OyPlanmeca VisoPDF
K2311812023-12-14Dentium Co., Ltd (Ict Branch)bright CTFDA
K2324872023-09-14Durr Dental SEProvecta 3D Prime and Provecta 3D Prime CephPDF

其中 22 件的 Summary 已存档在本站,点 PDF 直接下载;其余给 FDA 官方链接。

FDA 官方分类页: OAS
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA(CC0 公有领域),不构成注册策略建议。