# K201667: Midmark Extraoral Imaging System (EOIS)

- Pathway: 510(k) (Traditional)
- Applicant: Midmark Corporation
- Decided: Aug 6, 2020 after 48 days
- Product code: OAS (X-Ray, Tomography, Computed, Dental)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K973642 (1997). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160166: X-MIND trium, De Gotzen S.R.L. (2016) Summary page 5.
- K122643: Vantage Model V5000, V5100, V5000C, V5100C, Midmark Corp. (2013) Summary page 5.

## Indications for use
The intended use of the Midmark EOIS is to provide dental radiographic examination to aid in the diagnosis of diseases of the teeth, jaw and oral structures. When the system is equipped with the cephalometric option, the system will provide cephalometric radiographic examinations for use in orthodontic treatment planning and evaluation. When the system is equipped with the CBCT option, the system will also provide volumetric and tomographic images of the oral and maxillofacial region, for diagnostic examination of teeth, jaws, oral structures, and some cranial bones.

Source page: https://510kreport.com/device/K201667
Methodology: https://510kreport.com/methodology