# K041937: Restitu

- Pathway: 510(k) (Traditional)
- Applicant: Resonant Medical, Inc.
- Decided: Nov 16, 2004 after 120 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: 4 generations back to K851659 (1985). 13 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981424: Nomos Bat Ultrasound Localization and Positioning System, Nomos Corp. (1998) Summary page 1.
- K032100: I-BEAM, Computerized Medical Systems, Inc. (2003) Summary page 1.
- K030981: Eclipse, Varian Medical Systems, Inc. (2003) Summary page 1.
- K923851: Acqsim Simulator/Localizer, Philips Medical Systems (Cleveland), Inc. (1992) Summary page 1.

## Most influential descendants
- K111332: Clarity Obp System (2012), 2 descendants of its own
- K121663: Clarity (2012), 1 descendant of its own
- K141855: Clarity (2014), 0 descendants of its own

## Indications for use
RESTITU™ can be used for the positioning of patients that are prescribed external beam radiation treatments to organs which are readily identifiable on ultrasound images.

Source page: https://510kreport.com/device/K041937
Methodology: https://510kreport.com/methodology