# K041078: Surgplan and Panplan

- Pathway: 510(k) (Traditional)
- Applicant: Imaging Sciences Intl., Inc.
- Decided: Dec 23, 2004 after 241 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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) SimPlant: named in the summary without a submission number
- (no number) CDRPan and CDR DICOM: named in the summary without a submission number

## Most influential descendants
- K051715: Starpacs Dental (2005), 0 descendants of its own

## Indications for use
SurgPLAN and PanPlan are Software packages that scan (scan film using optical scanner or Direct Digital Capture using Solid State Sensor) and store images produced by Imaging Sciences International's (or other manufacturer's) Tomographic, Panoramic and Cephlometric imaging machines. Additionally, the software has the ability to import DICOM images from volumetric data sets for visualization, analysis and reporting. The software allows the practitioner to perform surgical demonstrations for dental implant planning, cephlometric analysis, measurements and bone graft visualizations. The purpose of the software is to provide the doctor with a convenient method for visualization of these multiple imaging modalities and communication between multiple practitioners and to demonstrate treatment plan for the patient.

Source page: https://510kreport.com/device/K041078
Methodology: https://510kreport.com/methodology