# K973642: Orthopantomograph OP100 and Orthoceph OC100

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentarium Imaging, Inc.
- Decided: Nov 21, 1997 after 58 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.
96 later devices descend from it; 4 cite it directly.
0 of 97 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
- K063773: Volumetric  Tomography (2007), 68 descendants of its own
- K082350: PAX-500 (2008), 67 descendants of its own
- K090171: Computed Tomography X-Ray System, Pax-REVE3D (2009), 59 descendants of its own
- K102259: Dental Computed Tomography X-Ray System (2011), 42 descendants of its own
- K121412: Pax-FLEX3D, PHT-7000 (2012), 28 descendants of its own

## Indications for use
Orthopantomograph® OP100 and Orthoceph® OC100 are intended to be used for producing diagnostic x-ray radiographs of dentition, TM-joints and skull. Ortho Trans option produces cross-sectional and lateral images of dental arch using linear tomographic method.

Source page: https://510kreport.com/device/K973642
Methodology: https://510kreport.com/methodology