FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The Planmeca Dimax Digital Panoramic X-ray Unit is an extraoral source X-ray system, which is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. This device is a multimode imaging system, which combines following imaging procedures:

Narrow beam tomography (= panoramic mode)
Cephalometric radiography

The use of the device is allowed only under supervision of a dentist.

Device Description

The Planmeca Dimax Digital Panoramic X-ray Unit is an extraoral source X-ray system.

AI/ML Overview

This letter primarily serves as an FDA clearance for the Planmeca Dimax Digital X-ray device and provides general regulatory information. It does not include details about specific acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot provide the requested information from the given text. The provided document is a regulatory approval letter, not a technical report or study summary that would contain performance data and acceptance criteria.

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K Number

K970263

Device Name

PM 2002 CC PROLINE

Manufacturer

PLANMECA OY

Date Cleared

1997-02-26

(34 days)

Product Code