# K042861: Odyssey

- Pathway: 510(k) (Traditional)
- Applicant: Permedics, Inc.
- Decided: Jan 12, 2005 after 89 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K993895 (2000). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002237: P3IMRT TM, Adac Laboratories (2001) Summary page 1.
- K993895: Optirad, Permedics, Inc. (2000) Summary page 1.

## Most influential descendants
- K062032: Accusoft, Accusoft XL (2006), 1 descendant of its own
- K063482: Crossplan / Accusoft-XL V.4.04 (2006), 0 descendants of its own

## Recalls of this device
- Nov 4, 2010 · Not classified · Z-0345-2012: Anomaly 1 - Invalid Export of Beam Table and or Collimator Angle for DICOM RT Ion, DICOM Image and RTP Link export files: During PerMedics' internal code reviews for lEC 61217 compliance verification,
- Mar 23, 2010 · Not classified · Z-1609-2010: Anomaly 1, Invalid Characters in Patient ID Error: Currently, Odyssey considers a valid ID to be comprised of numbers and/or letters. If a patient ID in a study contains a character other than a lette

## Indications for use
Odyssey is to be used for the computation, display, evaluation and output of radiation dose estimations to be submitted for independent clinical review and judgment prior to use in radiation therapy.

Source page: https://510kreport.com/device/K042861
Methodology: https://510kreport.com/methodology