FDA 510(k)

Dental Image Plate Scanner, Model DFC-4T-SMART

Номер K: K214091 · 2022-03-02

ЗаявительHefei Dentafilm Medical Equipment Co., Ltd.

Дата решения2022-03-02

Код продуктаMUH

Консультативный комитетDE

РешениеSubstantially Equivalent

Описание устройства

Dental Image Plate Scanner, Model DFC-4T-SMART is the device name listed in this FDA 510(k) record. The listed applicant is Hefei Dentafilm Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2022-03-02 under 510(k) number K214091. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Dental Image Plate Scanner, Model DFC-4T-SMART?

Dental Image Plate Scanner, Model DFC-4T-SMART is a medical device that received FDA 510(k) clearance on 2022-03-02. The listed applicant is Hefei Dentafilm Medical Equipment Co., Ltd.. The 510(k) number is K214091.

When did Dental Image Plate Scanner, Model DFC-4T-SMART receive FDA 510(k) clearance?

Dental Image Plate Scanner, Model DFC-4T-SMART received FDA 510(k) clearance on 2022-03-02, under 510(k) number K214091.

Who is the listed applicant for Dental Image Plate Scanner, Model DFC-4T-SMART?

The FDA 510(k) record lists Hefei Dentafilm Medical Equipment Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dental Image Plate Scanner, Model DFC-4T-SMART?

The FDA product code for Dental Image Plate Scanner, Model DFC-4T-SMART is MUH.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Связанные устройства (Код: MUH)

K251793SOTA Cloud Smart Sensor (1.5)Sota Cloud Corp.K252570EzSensor HD, EzSensor UHDQpix Solutions, Inc.K250687Cocoon Solo (DX-7020s)Dexcowin Global, Inc.K251206Digital X-Ray DentiMax Pro Imaging SystemDentimax, Inc.K240040VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan)VATECH Co., Ltd.K242778X Sensor (Model: IOS-A15IF, HDI-15DGF)Qpix Solutions, Inc.

Официальный источник

Посмотреть в базе данных FDA →

Данные получены из открытого API FDA. Для получения наиболее актуальной и авторитетной информации всегда обращайтесь к официальным записям.