# K991133: MLC Fit

- Pathway: 510(k) (Traditional)
- Applicant: Impac Medical Systems, Inc.
- Decided: Mar 27, 2000 after 360 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 K962335 (1997). 1 ancestor in all.
9 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962335: MLC Fit, Impac Medical Systems, Inc. (1997) Summary page 1.

## Most influential descendants
- K120067: Mosaiq Oncology Information System (2012), 8 descendants of its own
- K142142: Quality Reports (2014), 5 descendants of its own
- K162468: ClearCheck (2016), 4 descendants of its own
- K220583: ClearCheck Model RADCC V2 (2022), 3 descendants of its own
- K231185: MapRT (2023), 1 descendant of its own

## Indications for use
MLC Fit is to be used to define leaf plans for use with radiation treatment machines equipped with multileaf collimators manufactured by Siemens Medical Systems, Varian Associates, and Elekta Oncology Systems, Inc. This method of defining the geometric parameters associated with treatment fields can be used whenever a conformal treatment field is desired.

Source page: https://510kreport.com/device/K991133
Methodology: https://510kreport.com/methodology