Ev Apan Digital, Model K1VSM2000

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K041120 ↗

FDA Product Code

MUH

Device Class

Class II

Regulation

21 CFR Part 872.1800

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K922443 Active Cleared 26 Oct 1992

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  FDA 510(k) K843917 Active Cleared 3 Jan 1985

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  FDA 510(k) K925684 Active Cleared 2 Feb 1993

• Eva Select Digital Dental Imaging System

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  FDA 510(k) K123419 Active Cleared 27 Dec 2012

See all devices from Afp Imaging Corp. →

• What is the primary function of the Ev Apan Digital K1VSM2000?

  This device serves as an extraoral digital X-ray source system. It is designed to integrate with standard dental panoramic X-ray systems and dental image management software to facilitate image capture, enhancement, and data storage.

• Who is authorized to operate this X-ray system?

  The device is intended for use exclusively by qualified dental professionals. This ensures that the equipment is operated by individuals with the necessary training to manage dental imaging procedures safely and effectively.

• What is the regulatory status of this device?

  The Ev Apan Digital, Model K1VSM2000 has received FDA 510(k) clearance. It is categorized under regulation number 872.1800, which pertains to extraoral source X-ray systems used in dental applications.