# K962335: MLC Fit

- Pathway: 510(k) (Traditional)
- Applicant: Impac Medical Systems, Inc.
- Decided: Feb 6, 1997 after 234 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.
10 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)
- None. The FDA summary names its predicate without a number.
- (no number) Philips MLC Prescription Entry System: named in the summary without a submission number

## Most influential descendants
- K991133: MLC Fit (2000), 9 descendants of its own
- 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

Source page: https://510kreport.com/device/K962335
Methodology: https://510kreport.com/methodology