FDA 510(k)

X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology)

N.º K: K203374 · 2021-02-05

Fecha de decisión2021-02-05

Código de productoMUH

Comité asesorDE

DecisiónSubstantially Equivalent

Resumen del dispositivo

X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology) is the device name listed in this FDA 510(k) record. The listed applicant is De Götzen S.R.L.. It received FDA 510(k) clearance on 2021-02-05 under 510(k) number K203374. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology)?

X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology) is a medical device that received FDA 510(k) clearance on 2021-02-05. The listed applicant is De Götzen S.R.L.. The 510(k) number is K203374.

When did X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology) receive FDA 510(k) clearance?

X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology) received FDA 510(k) clearance on 2021-02-05, under 510(k) number K203374.

Who is the listed applicant for X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology)?

The FDA 510(k) record lists De Götzen S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology)?

The FDA product code for X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology) is MUH.

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 De Götzen S.R.L. como solicitante

K231055x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology)

Dispositivos relacionados (Código: 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.

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.