FDA 510(k)

Famille de Scanners NM AnyScan 3.0

Numéro K : K253844 · 2025-12-30

DemandeurMediso Medical Imaging Systems, Ltd.

Date de décision2025-12-30

Code produitKPS

Comité consultatifRA

DécisionSubstantially Equivalent

Résumé du dispositif

AnyScan 3.0 NM Scanner Family is the device name listed in this FDA 510(k) record. The listed applicant is Mediso Medical Imaging Systems, Ltd.. It received FDA 510(k) clearance on 2025-12-30 under 510(k) number K253844. 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 AnyScan 3.0 NM Scanner Family?

AnyScan 3.0 NM Scanner Family is a medical device that received FDA 510(k) clearance on 2025-12-30. The listed applicant is Mediso Medical Imaging Systems, Ltd.. The 510(k) number is K253844.

When did AnyScan 3.0 NM Scanner Family receive FDA 510(k) clearance?

AnyScan 3.0 NM Scanner Family received FDA 510(k) clearance on 2025-12-30, under 510(k) number K253844.

Who is the listed applicant for AnyScan 3.0 NM Scanner Family?

The FDA 510(k) record lists Mediso Medical Imaging Systems, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AnyScan 3.0 NM Scanner Family?

The FDA product code for AnyScan 3.0 NM Scanner Family 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.