LogoFDA 510(k) Search
K Number
K070658
Device Name
DENTAL DIGITAL PANORAMIC/3D IMAGING SYSTEM
Manufacturer
E-WOO TECHNOLOGY
Date Cleared
2007-04-05

(27 days)

Product Code
JAK
Regulation Number
892.1750
Type
Traditional
Panel
RA
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

EPX-Impla is a computed tomography x-ray system that acquires a 360° rotational sequence of the head and neck areas, including the ENT and dentomaxillofacial area for use in diagnostic support. The device is operated and used by physicians, dentists, and x-ray technologists.

Device Description

E-Woo Dental Imaging System Model EPX-Impla is a computed tomography x-ray system.

AI/ML Overview

The provided text describes an FDA 510(k) clearance letter for the "E-WOO Dental Imaging System Model EPX Impla." This document is notification of substantial equivalence, not a study report. Therefore, it does not contain the detailed information about acceptance criteria, device performance, study design, or ground truth establishment that would typically be found in a clinical study report or a pre-market approval application (PMA).

The letter indicates that the device has been found substantially equivalent to legally marketed predicate devices, meaning that "the device is at least as safe and effective as the predicate device." However, it does not provide specific performance metrics or the study that demonstrates this.

Therefore, I cannot provide the requested information from the given text. The text does not elaborate on:

  1. A table of acceptance criteria and the reported device performance.
  2. Sample size used for the test set and data provenance.
  3. Number of experts used to establish ground truth and their qualifications.
  4. Adjudication method for the test set.
  5. Whether an MRMC comparative effectiveness study was done or its effect size.
  6. Whether a standalone performance study was done.
  7. The type of ground truth used.
  8. The sample size for the training set.
  9. How the ground truth for the training set was established.

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.