# K091197: Planmeca Prosensor

- Pathway: 510(k) (Traditional)
- Applicant: Planmeca Oy
- Decided: Jul 29, 2009 after 97 days
- Product code: EHD (Unit, X-Ray, Extraoral With Timer)
- Device class: 2
- Regulation: 21 CFR 872.1800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K000428 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000428: DIXI 2, Planmeca Oy (2000) Summary page 1.

## Indications for use
Planmeca ProSensor, digital intraoral x-ray imaging system, is an accessory to dental intraoral x-ray devices. It is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures'. The device is digital, and the images are displayed on a monitor, and image manipulation, archiving and communication are performed via a computer. The device is to be operated and used by dentists and other legally qualified professionals.

Source page: https://510kreport.com/device/K091197
Methodology: https://510kreport.com/methodology