# K972968: Rotograph Plus

- Pathway: 510(k) (Traditional)
- Applicant: Chicago X-Ray Systems, Inc.
- Decided: Oct 8, 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Belmont X-Caliber unit: named in the summary without a submission number

## Most influential descendants
- K031801: Pantos, Models: Pantos 16, and Pantos DG (2003), 1 descendant of its own
- K161131: FONA Pan/Ceph (2016), 0 descendants of its own

## Indications for use
The Rotograph Plus as manufactured by Villa Sistemi Medicali S.p.A of Milan, Italy is intended to be used as an extra oral radiological device for the examination of the human dentition and related anatomy as well as craniostatic examinations. They are to be used for Panoramic and Cephalometric Radiology as it is applied to dental diagnosis in dentistry

Source page: https://510kreport.com/device/K972968
Methodology: https://510kreport.com/methodology