Cleared Traditional

K993895 - OPTIRAD

K993895 is an FDA 510(k) clearance for OPTIRAD, 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 199-day FDA review.

K993895 · Permedics, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
199d
Days
Class 2
Risk

K993895 is an FDA 510(k) clearance for the OPTIRAD. Classified as System, Planning, Radiation Therapy Treatment (product code MUJ), Class II - Special Controls.

Submitted by Permedics, Inc. (Irvine, US). The FDA issued a Cleared decision on June 2, 2000 after a review of 199 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Permedics, Inc. devices

FDA 510(k) Submission Details - K993895

510(k) Number K993895 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1999
Decision Date June 02, 2000
Days to Decision 199 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
92d slower than avg
Panel avg: 107d · This submission: 199d
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 185
Devices cleared under the same product code (MUJ) and FDA review panel - the closest regulatory comparables to K993895.
PROTON VISION 7.0
K002312 · Varian Medical Systems, Inc. · Aug 2000
BRAINSCAN
K994413 · Brainlab AG · Jul 2000
XPLAN 2.1
K001700 · Radionics, Inc. · Jun 2000
PROTON VISION
K000922 · Varian Assoc., Inc. · May 2000
ADAC PINNACLE3TM RADIATION THERAPY PLANNING SYSTEM
K993923 · Adac Laboratories · Apr 2000
SONOGRAPHIC PLANNING OF ONCOLOGY TREATMENTS (SPOT), MODEL V.. 1.0
K992303 · Nucletron Corp. · Mar 2000