# K213278: Planmed Verity

- Pathway: 510(k) (Traditional)
- Applicant: Planmed OY
- Decided: Apr 28, 2022 after 209 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: 6 generations back to K973598 (1997). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180918: Planmed Verity, Planmed OY (2018) Summary page 4.

## Indications for use
Planmed Verity is intended to be used for X-ray computed cone beam tomography imaging of anatomies within upper and lower extremities, head and neck.

Source page: https://510kreport.com/device/K213278
Methodology: https://510kreport.com/methodology