# K991815: Explorer 3D

- Pathway: 510(k) (Traditional)
- Applicant: Our Scientific Intl., Inc.
- Decided: Aug 13, 1999 after 78 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- Device class: 2
- Regulation: 21 CFR 892.5050
- 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 K970464 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970464: P Reference TPS (Treatment Planning Software) 1.1, Northwest Medical Physics Equipment, Inc. (1997) Summary page 2.

## Indications for use
The indications for use are applicable as previously presented for pReference TPS (K970464), such intracranial diseases as gliomas, neuromas, meningiomas, astroctyomas, arteriovenous malformations, and metastatic carcinomas. The software is used to electronically import CT images containing the target to be irradiated, to determine the precise location of the the target, to define and visualize treatment beam locations, and to visualize dose to the target and other structures.

Source page: https://510kreport.com/device/K991815
Methodology: https://510kreport.com/methodology