# K993895: Optirad

- Pathway: 510(k) (Traditional)
- Applicant: Permedics, Inc.
- Decided: Jun 2, 2000 after 199 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
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 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) Rocs TPS: named in the summary without a submission number

## Most influential descendants
- K032171: Accusoft (2003), 3 descendants of its own
- K042861: Odyssey (2005), 2 descendants of its own
- K040474: Accusoft (2004), 2 descendants of its own
- K062032: Accusoft, Accusoft XL (2006), 1 descendant of its own
- K063482: Crossplan / Accusoft-XL V.4.04 (2006), 0 descendants of its own

## Indications for use
The OptiRad software is to be used for the computation, display, evaluation and output documentation of radiation dose estimations to be submitted for independent clinical review and judgement prior to use. The device provides output data in the form of displays and/or hardcopies to guide a physician in selecting the optimum patient treatment plan. It is intended to provide a report to be used by a competent health professional such as a radiation oncologist, medical physicist, radiation therapist or dosimetrist.

Source page: https://510kreport.com/device/K993895
Methodology: https://510kreport.com/methodology