FDA 510(k)

CBit Series Digital Color Doppler Ultrasound System

Numéro K : K180974 · 2018-08-17

DemandeurCHISON Medical Technologies Co., Ltd.

Date de décision2018-08-17

Code produitIYN

Comité consultatifRA

DécisionSubstantially Equivalent

Résumé du dispositif

CBit Series Digital Color Doppler Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is CHISON Medical Technologies Co., Ltd.. It received FDA 510(k) clearance on 2018-08-17 under 510(k) number K180974. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the CBit Series Digital Color Doppler Ultrasound System?

CBit Series Digital Color Doppler Ultrasound System is a medical device that received FDA 510(k) clearance on 2018-08-17. The listed applicant is CHISON Medical Technologies Co., Ltd.. The 510(k) number is K180974.

When did CBit Series Digital Color Doppler Ultrasound System receive FDA 510(k) clearance?

CBit Series Digital Color Doppler Ultrasound System received FDA 510(k) clearance on 2018-08-17, under 510(k) number K180974.

Who is the listed applicant for CBit Series Digital Color Doppler Ultrasound System?

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

What is the FDA product code for CBit Series Digital Color Doppler Ultrasound System?

The FDA product code for CBit Series Digital Color Doppler Ultrasound System is IYN.

Essais cliniques associés

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

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

Autres dossiers indiquant CHISON Medical Technologies Co., Ltd. en tant que demandeur

K253949SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 Exp, SonoPort 1 Pro, SonoPort 1 Elite, SonoPort 1 Plus, SonoPort 2, SonoPort 2 Exp, SonoPort 2 Pro, SonoPort 2 Elite, SonoPort 2 Plus, SonoPort 3, SonoPort 3 Exp, SonoPort 3 Pro, SonoPort 3 Elite, SonoPort 3 Plus, SonoPort 4, SonoPort 4 Exp, SonoPort 4 Pro, SonoPort 4 Elite, SonoPort 4 Plus, SonoPort 5, SonoPort 5 Exp, SonoPort 5 Pro, SonoPort 5 Elite, SonoPort 5 Plus, SonoPort 6, SonoPort 6 Exp, SonoPort 6 K233697SonoMax Series Digital Color Doppler Ultrasound System K223570SonoAir Series Digital Color Doppler Ultrasound System K202457M1 Surgical Face Mask K201965SonoEye P1/ SonoEye P1-G/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital Color Doppler Palm Ultrasound System K201968SonoEye P3/ SonoEye V3/ Sono Eye G3 Digital Color Doppler Palm Ultrasound System

Voir tous les 11 dispositifs →

Dispositifs connexes (Code : IYN)

Source officielle

Voir dans la base de données FDA →

Données issues de l'API ouverte de la FDA. Pour les informations les plus récentes et faisant autorité, veuillez toujours vous référer au registre officiel.