FDA 510(k)

VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)

N.º K: K230600 · 2023-04-28

SolicitanteSpectrum Dynamics Medical, Ltd.

Fecha de decisión2023-04-28

Código de productoKPS

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464) is the device name listed in this FDA 510(k) record. The listed applicant is Spectrum Dynamics Medical, Ltd.. It received FDA 510(k) clearance on 2023-04-28 under 510(k) number K230600. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)?

VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464) is a medical device that received FDA 510(k) clearance on 2023-04-28. The listed applicant is Spectrum Dynamics Medical, Ltd.. The 510(k) number is K230600.

When did VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464) receive FDA 510(k) clearance?

VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464) received FDA 510(k) clearance on 2023-04-28, under 510(k) number K230600.

Who is the listed applicant for VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)?

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

What is the FDA product code for VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)?

The FDA product code for VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464) is KPS.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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

Otros registros que enlistan a Spectrum Dynamics Medical, Ltd. como solicitante

K254001VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)K253532TruSPECT Processing Station K212230TruSPECT Radiological Image Processing Station K190457VERITON CT whole body SPECT/CT system K182484VERITON CT whole body SPECT/CT system K180514VERITON NM

Ver todos los 8 dispositivos →

Dispositivos relacionados (Código: KPS)

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.