# K003437: Odyssey LX, Model 211320

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems (Cleveland), Inc.
- Decided: Feb 2, 2001 after 88 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
42 later devices descend from it; 3 cite it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K013673: HI-Art System (2002), 27 descendants of its own
- K033347: Modification to: HI-Art System (2003), 26 descendants of its own
- K042739: HI-Art System (2004), 25 descendants of its own
- K060912: Modification to: HI-Art System (2006), 24 descendants of its own
- K082005: Modification to HI-Art Treatment System (2008), 13 descendants of its own

## Recalls of this device
- Sep 15, 2003 · Not classified · Z-0093-04: Due to a software anomaly, an incorrect patient name may be transmitted with image to Odyssey workstation.

Source page: https://510kreport.com/device/K003437
Methodology: https://510kreport.com/methodology