Cleared Traditional

K040688 - STANDARD IMAGING E.IMRT CALCULATOR

K040688 is an FDA 510(k) clearance for STANDARD IMAGING E.IMRT CALCULATOR, manufactured by Standard Imaging, Inc.. The device is a Class 2 Radiology device with product code MUJ cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K040688 · Standard Imaging, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2004
Decision
56d
Days
Class 2
Risk

K040688 is an FDA 510(k) clearance for the STANDARD IMAGING E.IMRT CALCULATOR. Classified as System, Planning, Radiation Therapy Treatment (product code MUJ), Class II - Special Controls.

Submitted by Standard Imaging, Inc. (Middleton, US). The FDA issued a Cleared decision on May 11, 2004 after a review of 56 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 - K040688

510(k) Number K040688 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2004
Decision Date May 11, 2004
Days to Decision 56 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
51d faster than avg
Panel avg: 107d · This submission: 56d
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 256
Devices cleared under the same product code (MUJ) and FDA review panel - the closest regulatory comparables to K040688.
TRIMED PLAN, VERSION 2.2
K031088 · Trimed Systems, Inc. · Jul 2004
ONCENTRA-VISIR
K041719 · Nucletron Corp. · Jul 2004
ACCUSOFT
K040474 · Direx Systems Corp. · Jun 2004
ERGO SRS
K031281 · 3D Line USA, Inc. · Dec 2003
PROWESS
K032456 · Prowess, Inc. · Oct 2003
PINNACLE3 RADIATION THERAPY PLANNING SYSTEM
K032724 · Adac Laboratories · Oct 2003
K040688 · STANDARD IMAGING E.IMRT CALCULATOR
Download PDF FDA Summary Standard Imaging, Inc.