# K970812: PM 2002 CC Proline

- Pathway: 510(k) (Traditional)
- Applicant: Planmeca Oy
- Decided: Aug 5, 1997 after 153 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
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K040748: Ana-Bel, Model 087D and Ana-Bel CM, Model 187-CM (2004), 4 descendants of its own
- K090020: Bel-Cypher, Model Y977 (2009), 2 descendants of its own
- K110160: Bel-Cypher N (2011), 1 descendant of its own
- K163175: Bel-Cypher Pro (2017), 0 descendants of its own
- K062529: Belmax CM Model X168 (2006), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K970812
Methodology: https://510kreport.com/methodology