FDA 510(k)

VersaVue 单次使用柔性膀胱镜，VersaVue 平板电脑，和 VersaVue 视频盒

K号: K223926 · 2023-10-06

申请人Medimaging Integrated Solution, Inc (Miis)

决定日期2023-10-06

产品代码FAJ

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决定实质等同

器械摘要

VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box is the device name listed in this FDA 510(k) record. The listed applicant is Medimaging Integrated Solution, Inc (Miis). It received FDA 510(k) clearance on 2023-10-06 under 510(k) number K223926. The device is classified under product code FAJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box?

VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box is a medical device that received FDA 510(k) clearance on 2023-10-06. The listed applicant is Medimaging Integrated Solution, Inc (Miis). The 510(k) number is K223926.

When did VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box receive FDA 510(k) clearance?

VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box received FDA 510(k) clearance on 2023-10-06, under 510(k) number K223926.

Who is the listed applicant for VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box?

The FDA 510(k) record lists Medimaging Integrated Solution, Inc (Miis) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box?

The FDA product code for VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box is FAJ.

列明Medimaging Integrated Solution, Inc (Miis)为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K253217MiiS Horus 眼镜镜片（EJA 100）；MiiS Horus 内窥镜显示系统 - 平板（EDS 500）；MiiS Horus 内窥镜显示系统 - 视频盒（EVS 700）K234113MiiS Horus 支气管镜；MiiS Horus 内窥镜显示系统 - 平板；MiiS Horus 内窥镜显示系统 - 视频盒 K214050ENT 鼻咽镜及其附件 K193188MiiS Horus 眼前部摄像头 K181260MiiS Horus Scope DPT 100 K170470数字眼前端摄像机

查看所有 7 个设备 →

相关器械（代码：FAJ）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K260649OES ELITE 球囊内镜及其附件；球囊，17 Fr. (WA2C17BO)；球囊，19.8 Fr. (WA2C19BO)；球囊，21 Fr. (WA2C21BO)；球囊，21 Fr.，用于带斜坡的套管 (WA2C21RO)；球囊，21 Fr.，长 (WA2C21LO)；球囊，21 Fr.，用于直型套管 (WA2C21SO)；球囊，22.5 Fr. (WA2C22BO)；球囊，25 Fr. (WA2C25BO)；光学球囊，19.8 Fr. (WA2C19BV)；光学球囊，21 Fr. (WA2C21BV)；光学球囊，21 Fr.，用于直型套管 (WA2C21SV)；光学球囊，Olympus Winter & Ibe GmbH K253696CFlex膀胱镜 - 标准偏转（0570-0455）；CFlex膀胱镜 - 反向偏转（0570-0456）；CystoView监视器（0570-0465）Verathon Medical (Canada) Ulc K253892Strauss Surgical膀胱镜和宫腔镜（STS-2040-302ASA HD内窥镜，4 x 302 mm，视角. 直. 0°，标准型，可高压灭菌）；Strauss Surgical膀胱镜和宫腔镜（STS-2040-302AA HD内窥镜，4 x 302 mm，视角. 直. 0°，广角，可高压灭菌）；Strauss Surgical膀胱镜和宫腔镜（STS-2040-302BA HD内窥镜，4 x 302 mm，视角. 直. 30°，广角，可高压灭菌）；Strauss Surgical膀胱镜和宫腔镜（STS-2040-302BSA HD内窥镜，4 x 302 mm，视角. 直. 30°，Strauss Surgical USA K253905PrimeSight UltraView系统Cogentix Medical, Inc.K260271Strauss Surgical膀胱镜、宫腔镜和配件工具American Medical Endoscopy, Inc.K253226UV5000W 处理器Uroviu Corporation

官方来源

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