# K981911: PROFA

- Pathway: 510(k) (Traditional)
- Applicant: Duncan Hynd Associates, Ltd.
- Decided: Nov 12, 1998 after 164 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
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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
For radiation therapy, patient/body contouring, virtual simulation and verification of the patient’s treatment plan. Provides any simulator with a fast, non-contact method for obtaining accurate patient contours. The results can be downloaded to the treatment planning computer. Profa is fully automatic and offers software solution for scanning and simulation of the breast, pelvis, head and neck, treatment masks and sagittal cases. The hand-held Profa plus system 1s portable and can be used in the radiotherapy room.

Source page: https://510kreport.com/device/K981911
Methodology: https://510kreport.com/methodology