# K961400: Rfa-300, Lda Utility

- Pathway: 510(k) (Traditional)
- Applicant: Scanditronix Medical AB
- Decided: Jan 3, 1997 after 267 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 K934303 (1994). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934303: RFA A-300, Scanditronix, Inc. (1994) Summary page 1.
- (no number) Wellhofer MDA: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K882770: Wellhofer WP600. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K011763: Omnidos (2001), 1 descendant of its own
- K092018: Omnipro Incline (2009), 0 descendants of its own

## Indications for use
The Scanditronix Medical RFA-300, LDA Utility is used to more effectively perform radiation therapy beam measurements including acceptance testing, trimming information, routine beam checks and quality assurance measurements and on-line data analyses using personal computer (PC) monitor.

Source page: https://510kreport.com/device/K961400
Methodology: https://510kreport.com/methodology