FDA 510(k)

syngo. CT Single Source Dual Energy (twin beam)

Numéro K : K163289 · 2017-02-09

DemandeurSiemens Medical Solutions USA, Inc., Ultrasound DI

Date de décision2017-02-09

Code produitJAK

Comité consultatifRA

DécisionSubstantially Equivalent

Résumé du dispositif

syngo. CT Single Source Dual Energy (twin beam) is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions USA, Inc., Ultrasound DI. It received FDA 510(k) clearance on 2017-02-09 under 510(k) number K163289. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the syngo. CT Single Source Dual Energy (twin beam)?

syngo. CT Single Source Dual Energy (twin beam) is a medical device that received FDA 510(k) clearance on 2017-02-09. The listed applicant is Siemens Medical Solutions USA, Inc., Ultrasound DI. The 510(k) number is K163289.

When did syngo. CT Single Source Dual Energy (twin beam) receive FDA 510(k) clearance?

syngo. CT Single Source Dual Energy (twin beam) received FDA 510(k) clearance on 2017-02-09, under 510(k) number K163289.

Who is the listed applicant for syngo. CT Single Source Dual Energy (twin beam)?

The FDA 510(k) record lists Siemens Medical Solutions USA, Inc., Ultrasound DI as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for syngo. CT Single Source Dual Energy (twin beam)?

The FDA product code for syngo. CT Single Source Dual Energy (twin beam) is JAK.

Essais cliniques associés

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Source officielle

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