# K043612: Orthopantomograph OP200, OP200D, and Orthoceph OC200, OC200D

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentarium Corp. Imaging Division
- Decided: Feb 9, 2005 after 41 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 K973642 (1997). 3 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992385: Orthopantomograph OP100D, Instrumentarium Corp. (1999) Summary page 2.
- K001439: Orthoceph OC100 D, Instrumentarium Corp. (2000) Summary page 2.
- K973642: Orthopantomograph OP100 and Orthoceph OC100, Instrumentarium Imaging, Inc. (1997) Summary page 2.

## Most influential descendants
- K141700: Papaya Plus, Digital Extraoral Source X-Ray System (2014), 6 descendants of its own
- K150354: PAPAYA 3D Plus (2015), 4 descendants of its own
- K200469: PAPAYA 3D Premium & PAPAYA 3D Premium Plus (2020), 1 descendant of its own
- K122643: Vantage Model V5000, V5100, V5000C, V5100C (2013), 1 descendant of its own
- K250060: GT300; GT300-C (2025), 0 descendants of its own

## Indications for use
Orthopantomograph® OP200 (film unit) and OP200 D (digital unit) devices are intended to be used for producing X-ray radiographs of dentition, TM-joints and other oral structures. The units are capable of taking panoramic, TM-joint and maxillary sinus radiographs from patients. When the units are equipped with cephalometric option Orthoceph® OC200 (film unit) or OC200 D (digital unit) units can be used for cephalometric radiography and examinations related thereto. OP200 or OC200 units can also be equipped with Ortho Trans (OT) option, which is capable of taking both cross and longitudinal slices of region of interest. Ortho Trans uses linear tomography imaging principle.

Source page: https://510kreport.com/device/K043612
Methodology: https://510kreport.com/methodology