Cleared Traditional

K150547 - .decimal Astroid Dosimetry App

K150547 is an FDA 510(k) clearance for .decimal Astroid Dosimetry App, manufactured by .Decimal, Inc.. The device is a Class 2 Radiology device with product code MUJ cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K150547 · .Decimal, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2015
Decision
73d
Days
Class 2
Risk

K150547 is an FDA 510(k) clearance for the .decimal Astroid Dosimetry App. Classified as System, Planning, Radiation Therapy Treatment (product code MUJ), Class II - Special Controls.

Submitted by .Decimal, Inc. (Sanford, US). The FDA issued a Cleared decision on May 15, 2015 after a review of 73 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 - K150547

510(k) Number K150547 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2015
Decision Date May 15, 2015
Days to Decision 73 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
34d faster than avg
Panel avg: 107d · This submission: 73d
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
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