Cleared Traditional

K042861 - ODYSSEY

K042861 is an FDA 510(k) clearance for ODYSSEY, manufactured by Permedics, Inc.. The device is a Class 2 Radiology device with product code MUJ cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K042861 · Permedics, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2005
Decision
89d
Days
Class 2
Risk

K042861 is an FDA 510(k) clearance for the ODYSSEY. Classified as System, Planning, Radiation Therapy Treatment (product code MUJ), Class II - Special Controls.

Submitted by Permedics, Inc. (San Bernardino, US). The FDA issued a Cleared decision on January 12, 2005 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K042861

510(k) Number K042861 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2004
Decision Date January 12, 2005
Days to Decision 89 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 107d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MUJ Device Classification - Class 2, Special Controls

Product Code MUJ System, Planning, Radiation Therapy Treatment
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - MUJ System, Planning, Radiation Therapy Treatment

All 257
Devices cleared under the same product code (MUJ) and FDA review panel - the closest regulatory comparables to K042861.
CYBERNIFE STEREOTACTIC RADIOSURGERY SYSTEM
K051941 · Accuray, Inc. · Aug 2005
VITESSE 2.0
K051497 · Varian Medical Systems, Inc. · Jul 2005
WIMRT MODULE FOR ARTP PLANNING SYSTEM
K041971 · Prodigm Group, Inc. · May 2005
HI-ART SYSTEM
K042739 · Tomotherapy Incorporated · Nov 2004
LEKSELL GAMMAPLAN 4C WITH MULTIVIEW
K042269 · Elekta Instrument AB · Sep 2004
RADIONICS XKNIFE RT 3 WITH NON STEREOTACTIC MODULE
K041997 · Radionics, A Division of Tyco Healthcare Group LP · Aug 2004
K042861 · ODYSSEY
Download PDF FDA Summary Permedics, Inc.