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FDA 510(k)

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

K-Number: K152489 · 2016-02-04

ApplicantPanoramic Corp.
Decision Date2016-02-04
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Panoramic Corp.. The 510(k) number is K152489.

When was ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-Ray approved by the FDA?

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

What company makes ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-Ray?

ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-Ray is manufactured by Panoramic Corp..

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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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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