# K991518: Panatome

- Pathway: 510(k) (Traditional)
- Applicant: Imaging Sciences Intl., Inc.
- Decided: Jun 18, 1999 after 49 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.
No later device cites it as a predicate yet.
0 of 1 device 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) Imaging Sciences International Inc. CommCAT IS 2000 Tomographic X-Ray system: named in the summary without a submission number

## Indications for use
The Imaging Sciences International Inc. Panatome Imaging system is a multifunction computer controlled Tomographic X-Ray device for taking radiographs of the head and neck region. This device has the ability to produce panoramic and pluridirectional Tomographic images. The operator's manual describes the computerized operator interface for selecting and executing the various radiographic procedures. The panoramic function of this unit produces the same standard panoramic image as numerous other units in use for past several decades. The tomographic function is also similar to other units in use for past few decades, except it employs complex motion to produce tomographic slices as opposed to more commonly used linear motion. Slices produced by complex tomographic motion are superior and more accurate as compared to linear slices. Complex motion has been used by a few other units in the recent past. Tomographic imaging is commonly used for TM Joint studies, mandible & maxilla for implant planning, sinuses, etc.

Source page: https://510kreport.com/device/K991518
Methodology: https://510kreport.com/methodology