# K032100: I-BEAM

- Pathway: 510(k) (Traditional)
- Applicant: Computerized Medical Systems, Inc.
- Decided: Oct 2, 2003 after 86 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: 3 generations back to K851659 (1985). 9 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 14 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.
- K003285: Exac Trac 2.0 (Novalis Body Module), Brainlab AG (2001) Summary page 1.

## Most influential descendants
- K041937: Restitu (2004), 3 descendants of its own
- 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
I-Beam is a self-contained mobile patient positioning system that uses real time ultrasound images of patient target organs or tumors while the patient is positioned on the couch of the linear accelerator to confirm the location of these patient target organs or tumors prior to delivery of external beam radiation therapy.

Source page: https://510kreport.com/device/K032100
Methodology: https://510kreport.com/methodology