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Odyssey

by Permedics, Inc.

510(k) K042861

Odyssey is a Class II device made by Permedics, Inc., cleared under FDA 510(k) K042861 on 12 Jan 2005, active as of 22 Oct 2026. 2 FDA recalls are linked to it.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK042861 Date12 Jan 2005ClearedStatusActive

Official records

Recalls

2 recalls · FDA

    • Terminated Z-0345-2012 FDA Unclassified (pre-2012) initiated 4 Nov 2010

    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, an issue was identified by PerMedics engineers in three export files: D1COM RT Ion Plan, D1COM RT Image and RTP Link. In some cases, this issue can result in table and/or collimator angle values t

    • Terminated Z-1609-2010 FDA Unclassified (pre-2012) initiated 23 Mar 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 letter or number (including spaces). Odyssey removes the invalid character when moving it to a patient folder. Due to this, it is possible that two different patient studies could be listed within Odyssey

Timeline

3 dated events

  1. Cleared FDA 510(k) K042861
  2. Recall initiated FDA recalls Z-1609-2010
  3. Recall initiated FDA recalls Z-0345-2012

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
MUJ
Device class
Class II
Regulation
21 CFR Part 892.5050
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Similar devices

Other devices filed under FDA product code MUJ (System, Planning, Radiation Therapy Treatment).

Other devices from Permedics, Inc.