# K984241: Rocs Ultraseed

- Pathway: 510(k) (Traditional)
- Applicant: Radiation Oncology Computer Systems
- Decided: May 12, 1999 after 166 days
- Product code: IYE (Accelerator, Linear, Medical)
- 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 K862643 (1987). 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)
- K862643: Radiation Oncology Computer Sys Treatment Planning, Pacific Physics, Inc. (1987) Summary page 1.

## Indications for use
ROCS ULTRASEED™ (Prostate Ultrasound-guided Brachytherapy Planning System) is intended to be used for the computation, display, evaluation and output documentation of radiation dose estimations for prostate ultrasound-guided brachytherapy to be submitted for independent clinical review and judgment. The device provides output data in the form of displays, hardcopy prints and/or plots to guide a physician in selecting the optimum patient treatment plan and for documenting the actual implant. 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/K984241
Methodology: https://510kreport.com/methodology