FDA 510(k)

ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-Ray

Número K: K152489 · 2016-02-04

Data da decisão2016-02-04

Código do produtoOAS

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-Ray is the device name listed in this FDA 510(k) record. The listed applicant is Panoramic Corp.. It received FDA 510(k) clearance on 2016-02-04 under 510(k) number K152489. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-Ray?

ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-Ray is a medical device that received FDA 510(k) clearance on 2016-02-04. The listed applicant is Panoramic Corp.. The 510(k) number is K152489.

When did ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-Ray receive FDA 510(k) clearance?

ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-Ray received FDA 510(k) clearance on 2016-02-04, under 510(k) number K152489.

Who is the listed applicant for ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-Ray?

The FDA 510(k) record lists Panoramic Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-Ray?

The FDA product code for ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-Ray is OAS.

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