Cleared Traditional

K180289 - 3D Bolus Software

K180289 is an FDA 510(k) clearance for 3D Bolus Software, manufactured by 3D Bolus, Inc.. The device is a Class 2 Radiology device with product code MUJ cleared through the Traditional 510(k) pathway after a 159-day FDA review.

K180289 · 3D Bolus, Inc. · Radiology device
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Jul 2018
Decision
159d
Days
Class 2
Risk

K180289 is an FDA 510(k) clearance for the 3D Bolus Software. Classified as System, Planning, Radiation Therapy Treatment (product code MUJ), Class II - Special Controls.

Submitted by 3D Bolus, Inc. (Halifax, CA). The FDA issued a Cleared decision on July 10, 2018 after a review of 159 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 3D Bolus, Inc. devices

FDA 510(k) Submission Details - K180289

510(k) Number K180289 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2018
Decision Date July 10, 2018
Days to Decision 159 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
52d slower than avg
Panel avg: 107d · This submission: 159d
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 212
Devices cleared under the same product code (MUJ) and FDA review panel - the closest regulatory comparables to K180289.
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