FDA 510(k)

Ajout d'écrans pour le logiciel de traitement cardiaque P.E.T HeartSee approuvé par la FDA K143664

Numéro K : K171303 · 2017-09-22

DemandeurUniversity of Texas Medical School AT Houston, Texas

Date de décision2017-09-22

Code produitKPS

Comité consultatifRA

DécisionSubstantially Equivalent

Résumé du dispositif

Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664 is the device name listed in this FDA 510(k) record. The listed applicant is University of Texas Medical School AT Houston, Texas. It received FDA 510(k) clearance on 2017-09-22 under 510(k) number K171303. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664?

Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664 is a medical device that received FDA 510(k) clearance on 2017-09-22. The listed applicant is University of Texas Medical School AT Houston, Texas. The 510(k) number is K171303.

When did Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664 receive FDA 510(k) clearance?

Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664 received FDA 510(k) clearance on 2017-09-22, under 510(k) number K171303.

Who is the listed applicant for Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664?

The FDA 510(k) record lists University of Texas Medical School AT Houston, Texas as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664?

The FDA product code for Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664 is KPS.

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

Dispositifs connexes (Code : KPS)

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.